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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03319628
Registration number
NCT03319628
Ethics application status
Date submitted
17/10/2017
Date registered
24/10/2017
Titles & IDs
Public title
First-in-Human Study of XMT-1536 in Cancers Likely to Express NaPi2b
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Scientific title
A Phase 1b/2, First-in-Human, Dose Escalation and Expansion Study of XMT-1536 In Patients With Solid Tumors Likely to Express NaPi2b
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Secondary ID [1]
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XMT-1536-1
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Platinum Resistant Ovarian Cancer
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0
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Non Small Cell Lung Cancer Metastatic
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Metastatic Colorectal Cancer
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0
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Growth Hormone Deficiency, Pediatric
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0
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Endocrine System Diseases
0
0
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Hormone Deficiency
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0
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Pituitary Diseases
0
0
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Condition category
Condition code
Oral and Gastrointestinal
0
0
0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Infection
0
0
0
0
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Other infectious diseases
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Cancer
0
0
0
0
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Lung - Small cell
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Metabolic and Endocrine
0
0
0
0
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Other endocrine disorders
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Human Genetics and Inherited Disorders
0
0
0
0
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Other human genetics and inherited disorders
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Neurological
0
0
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0
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Other neurological disorders
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Cancer
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0
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0
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - upifitamab rilsodotin
Treatment: Drugs - TransCon hGH
Experimental: Dose Escalation - XMT-1536 (upifitamab rilsodotin) treatment is administered in groups of patients who will receive doses that increase over time.
This cohort is closed to enrollment.
Experimental: Dose Expansion - Ovarian Cancer - Once the maximum tolerated dose or recommended Phase 2 dose is achieved in dose escalation, new groups of patients will receive XMT-1536 (upifitamab rilsodotin) at this fixed-dose.
This cohort is closed to enrollment.
Experimental: Dose Expansion - NSCLC adenocarcinoma - Once the maximum tolerated dose or recommended Phase 2 dose is achieved in dose escalation, new groups of patients will receive XMT-1536 (upifitamab rilsodotin) at this fixed-dose.
This cohort is closed to enrollment.
Experimental: Pivotal Cohort (UPLIFT) - Patients with platinum-resistant ovarian cancer will receive XMT-1536 (upifitamab rilsodotin) to further confirm the efficacy.
This cohort is closed to enrollment.
Experimental: QTc Sub-Study - For sites participating in the sub-study, patients with platinum -resistant ovarian cancer will have the option to enroll in this sub-study to evaluate potential changes in the QTc interval following administration of XMT-1536.
This cohort is closed to enrollment.
Experimental: S95005 - Film-coated tablet containing 15 mg of trifluridine and 7.065 mg of tipiracil hydrochloride, or 20 mg of trifluridine and 9.42 mg of tipiracil hydrochloride, taken orally twice a day at the dose of 35 mg/m²/dose. The treatment is given until progression of disease, unacceptable toxicity, investigator decision, patient refusal or until market authorization or reimbursement has been granted by the relevant Authority of the country where that patient is treated or until trifluridine / tipiracil is available by a doctor's prescription or can be accessed from another source or Sponsor decision.
Experimental: TransCon hGH - Once weekly subcutaneous injection of TransCon hGH
Treatment: Drugs: upifitamab rilsodotin
XMT-1536 will be administered once every 28 days until disease progression, unacceptable toxicity, or either the patient or study physician determines it is in the best interest of the patient to discontinue participation in the study.
For sites participating in the sub-study, patients with platinum -resistant ovarian cancer will have the option to enroll in this sub-study to evaluate potential changes in the QTc interval following administration of XMT-1536
Treatment: Drugs: TransCon hGH
Once weekly subcutaneous injection at a starting dose of 0.24 mg/kg/week
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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DES: Maximum tolerated dose or recommended Phase 2 dose
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Assessment method [1]
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Evaluate adverse events and concomitant medication use after XMT-1536 (upifitamab rilsodotin) doses
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Timepoint [1]
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Up to 36 weeks, from the date of first dose until unacceptable side effects or a dose-limiting toxicity is met
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Primary outcome [2]
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DES and EXP: Safety and Tolerability
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Assessment method [2]
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Evaluate incidence and severity of adverse events
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Timepoint [2]
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First dose up until 30 days after study termination
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Primary outcome [3]
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EXP: Anti-neoplastic effects of XMT-1536 (upifitamab rilsodotin)
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Assessment method [3]
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Monitor tumor size
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Timepoint [3]
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Every 6 weeks for up to 36 weeks
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Primary outcome [4]
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UPLIFT: Investigator-assessed objective response rate (ORR) of XMT-1536 (upifitamab rilsodotin) in the ITT-Higher NaPi2b population
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Assessment method [4]
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Confirmed ORR is defined as the proportion of patients who have achieved a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 after the initiation of study treatment.
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Timepoint [4]
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Every 8 weeks until disease progression or up to 24 months
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Primary outcome [5]
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QTc Sub-study: Evaluation of the concentration response analysis of XMT-1536 versus the change in QTcF values
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Assessment method [5]
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"The concentration-QTcf change from baseline deltaQTcF analysis and analysis of central tendency for deltaQTcF
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Timepoint [5]
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60 minutes prior to first dose, up to 26 hours after Cycle 3 dose
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Primary outcome [6]
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Incidence of Adverse Events [safety and tolerability]
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Assessment method [6]
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Timepoint [6]
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Through 28 days following last administration of study medication
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Primary outcome [7]
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Abnormalities in laboratory assessment
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Assessment method [7]
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Timepoint [7]
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Through study completion, an average of 12 weeks
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Primary outcome [8]
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Abnormalities in performance status (ECOG)
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Assessment method [8]
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Timepoint [8]
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Through study completion, an average of 12 weeks
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Primary outcome [9]
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Abnormalities in vital signs
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Assessment method [9]
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Timepoint [9]
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Through study completion, an average of 12 weeks
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Primary outcome [10]
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Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]
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Assessment method [10]
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Safety and tolerability of weekly lonapegsomatropin (TransCon hGH) treatment
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Timepoint [10]
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26 weeks
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Secondary outcome [1]
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DES and EXP: Time of maximum observed concentration of XMT-1536 (upifitamab rilsodotin)
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Assessment method [1]
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Determine the pharmacokinetics of XMT-1536 (upifitamab rilsodotin)
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Timepoint [1]
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Daily for one week after first dose; weekly until 28 days after first dose; immediately before and after and 1 week after all subsequent doses
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Secondary outcome [2]
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DES and EXP: Maximum concentration of XMT-1536 (upifitamab rilsodotin)
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Assessment method [2]
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Determine the pharmacokinetics of XMT-1536 (upifitamab rilsodotin)
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Timepoint [2]
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Daily for one week after first dose; weekly until 28 days after first dose; immediately before and after and 1 week after all subsequent doses
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Secondary outcome [3]
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DES and EXP: Area under the concentration curve of the last measurable concentration of XMT-1536 (upifitamab rilsodotin)
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Assessment method [3]
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Determine the pharmacokinetics of XMT-1536 (upifitamab rilsodotin)
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Timepoint [3]
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Daily for one week after first dose; weekly until 28 days after first dose; immediately before and after and 1 week after all subsequent doses
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Secondary outcome [4]
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DES: Anti-neoplastic effects of XMT-1536 (upifitamab rilsodotin)
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Assessment method [4]
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Monitor tumor size
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Timepoint [4]
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Every 6 weeks for up to 36 weeks
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Secondary outcome [5]
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DES and EXP: Anti-drug antibody and neutralizing antibody
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Assessment method [5]
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Analyze blood for antibodies to XMT-1536 (upifitamab rilsodotin) and neutralizing antibodies
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Timepoint [5]
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Every 6 weeks for up to 36 weeks
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Secondary outcome [6]
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UPLIFT: Confirmed Investigator-assessed objective response rate of XMT-1536 (upifitamab rilsodotin) regardless of NaPi2b expression
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Assessment method [6]
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Assess the confirmed investigator-assessed objective response rate of XMT-1536 (upifitamab rilsodotin) regardless of NaPi2b expression
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Timepoint [6]
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Every 8 weeks until disease progression or up to 24 months
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Secondary outcome [7]
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UPLIFT: Confirmed objective response rate by independent radiology review (IRR) for patients with high NaPi2b and overall
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Assessment method [7]
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Assess the confirmed objective response rate by IRR for patients with high NaPi2b (TPS \>/=75) and overall
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Timepoint [7]
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Every 8 weeks until disease progression or up to 24 months
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Secondary outcome [8]
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UPLIFT: Duration of objective response (DOR)
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Assessment method [8]
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Assess the duration of objective response (DOR) in patients who achieve a response
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Timepoint [8]
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4 weeks after first response and every 8 weeks until disease progression or up to 24 months
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Secondary outcome [9]
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UPLIFT: Incidence and severity of adverse events
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Assessment method [9]
0
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Evaluate incidence and severity of adverse events
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Timepoint [9]
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First dose up until 60 days after study termination
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Secondary outcome [10]
0
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QTc Sub-Study: Evaluation of the effect of XMT-1536 on QTcF in patients with platinum-resistant HGSOC by timepoint analysis
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Assessment method [10]
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Con.-QTc evaluation
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Timepoint [10]
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60 minutes prior to first dose, up to 26 hours after Cycle 3 dose
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Secondary outcome [11]
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QTc Sub-Study: Evaluation of the effect of XMT-1536 on the PR-interval (PR), QRS duration (QRS), Heart Rate (HR), and ECG morphology
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Assessment method [11]
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Con.-QTc evaluation
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Timepoint [11]
0
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60 minutes prior to first dose, up to 26 hours after Cycle 3 dose
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Secondary outcome [12]
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Progression free survival (PFS)
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Assessment method [12]
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time from the date of first study drug intake until the date of the investigator-assessed disease progression or death due to any cause whichever occurs first.
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Timepoint [12]
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Through study completion, an average of 12 weeks
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Secondary outcome [13]
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Quality of life using the questionnaire EQ-5D
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Assessment method [13]
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0
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Timepoint [13]
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Through study completion, an average of 12 weeks
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Secondary outcome [14]
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Quality of life using the questionnaire EORTC QLQ-C30
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Assessment method [14]
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0
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Timepoint [14]
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Through study completion, an average of 12 weeks
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Secondary outcome [15]
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Annualized Height Velocity (AHV) at 26 Weeks of Weekly Lonapegsomatropin Treatment
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Assessment method [15]
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Annualized height velocity (AHV) at 26 weeks of weekly lonapegsomatropin (TransCon hGH) treatment. The AHV at each visit was modeled using ANCOVA adjusting for baseline age, peak GH levels (log transformed) at diagnosis, delta average-parental height SDS, prior GH dose level (log transformed), and prior GH dose duration (log transformed) as covariates and gender as a factor. Subjects who did not take prior GH treatment were not included in the model.
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Timepoint [15]
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26 weeks
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Secondary outcome [16]
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Number of Subjects With IGF-1 Standard Deviation Score (SDS) in the Range of 0.0 to +2.0 at 26 Weeks of Weekly Lonapegsomatropin Treatment
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Assessment method [16]
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IGF-1 Standard Deviation Score (SDS) is the number of standard deviations above or below the mean Insulin-like Growth Factor 1 (IGF-1) level for age and sex. IGF-1 SDS was derived using the LMS method as ((IGF-1/M)\^L)-1)/(L x S), where M = median, S = generalized coefficient of variation, and L = power in the Box-Cox transformation, the M, S, L values were obtained from Bidlingmaier et al. (2014). A Standard Deviation Score of 0 represents the population mean.
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Timepoint [16]
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26 weeks
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Secondary outcome [17]
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Change in Height Standard Deviation Scores (SDS) at 26 Weeks of Weekly Lonapegsomatropin Treatment
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Assessment method [17]
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Height Standard Deviation Score (SDS) is the number of standard deviations above or below the mean height for age and sex. Height SDS was derived using the LMS method as ((Height/M)\^L)-1)/(L x S), where M = median, S = generalized coefficient of variation, and L = power in the Box-Cox transformation, the M, S, L values were obtained from 2000 CDC growth charts for the United States. A Standard Deviation Score of 0 represents the population mean. A higher change from baseline in Height SDS indicates a better outcome. The height SDS change from baseline at each visit was modeled using ANCOVA adjusting for baseline age, peak GH levels (log transformed) at diagnosis, delta average-parental height SDS, prior GH dose level (log transformed), and prior GH dose duration (log transformed) as covariates and gender as a factor. Subjects who did not take prior GH treatment were not included in the model.
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Timepoint [17]
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Baseline and 26 weeks
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Secondary outcome [18]
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Number of Participants With Treatment Emergent Anti-hGH Binding Antibody Formation
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Assessment method [18]
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Number of participants with treatment emergent anti-hGH antibodies over 26 weeks of weekly lonapegsomatropin (TransCon hGH) treatment. All samples were negative for anti-hGH neutralizing antibodies.
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Timepoint [18]
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26 weeks
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Eligibility
Key inclusion criteria
General Inclusion Criteria (for Dose Escalation, Expansion, and UPLIFT):
* ECOG performance status 0 or 1
* Measurable disease as per RECIST, version 1.1
* Resolution of all acute toxic effects of prior therapy or surgical procedures to =Grade 1 (except alopecia, stable immune-related toxicity such as hypothyroidism on hormone replacement, adrenal insufficiency on =10 mg daily prednisone [or equivalent], chronic Grade 2 peripheral sensory neuropathy after prior taxane therapy).
* Cardiac left ventricular ejection fraction (LVEF) =50% or = the institution's lower limit of normal by either Echo or MUGA scan
* Adequate organ function as defined by the following criteria:
1. Absolute neutrophil count (ANC) =1500 cells/mm3
2. Platelet count =100,000/mm3
3. Hemoglobin =9 g/dL
4. In patients not on anticoagulation therapy: INR, activated partial thromboplastin time (aPTT), and prothrombin time (PT) all within 1.2 times the institution's upper limit of normal (ULN). Patients on anticoagulation therapy are allowed if their relevant laboratory values are within the therapeutic window.
5. Estimated glomerular filtration rate (GFR) =45 mL/min
6. Total bilirubin =ULN
7. g. Patients with asymptomatic elevations in unconjugated bilirubin due to Gilbert syndrome or stable chronic hemolytic anemia (e.g., hereditary spherocytosis, sickle cell disease, thalassemia intermedia) may be eligible after discussion with the Sponsor Medical Monitor.
* Aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) =1.5 times the institutional ULN.
* Albumin =3.0 g/dL
* Able to provide informed consent.
General
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria (for Dose Escalation, Expansion, and UPLIFT) :
* Major surgery within 28 days of starting study treatment, systemic anti-cancer therapy within the lesser of 28 days or 5 half-lives of the prior therapy before starting study treatment, or recent radiation therapy with unresolved toxicity or within a time window of potential toxicity.
* Patients with untreated CNS metastases (including new and progressive brain metastases), history of leptomeningeal metastasis or carcinomatous meningitis.
* Current known active infection with HIV, hepatitis B virus, or hepatitis C virus.
* Prior history of liver disease such as liver cirrhosis, hepatic fibrosis
* Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease) or intercurrent illness that could interfere with per-protocol evaluations.
* Current use of either constant or intermittent supplementary oxygen therapy.
* History of suspected pneumonitis or interstitial lung disease.
* Pregnant or nursing women.
* History of other malignancy within the last 2 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or other malignancy with a similar expected curative outcome.
* Active corneal disease, or history of corneal disease within 12 months prior to enrollment
* Use of strong CYP450 3A inhibitors or inducers that cannot be discontinued while receiving study treatment
* Oxygen saturation on room air <93%
Ovarian Cancer Inclusion Criteria for UPLIFT:
* Histological diagnosis of high grade serous ovarian cancer, which includes fallopian tube, or primary peritoneal cancer, that is metastatic or recurrent.
* Platinum-resistant disease
1. Patients who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum, must have had a response [complete response/remission (CR) or partial response/remission (PR)], and then progressed between 3 months and = 6 months after the date of the last dose of platinum
2. Patients who have received 2 to 4 lines of prior therapy must have received at least 4 cycles of platinum and then progressed within 6 months after the date of the last dose of platinum
* One to 4 prior lines of systemic therapy for ovarian cancer
a. Prior treatment with bevacizumab is required for patients with 1 to 2 prior lines of therapy
* Patients must be willing to provide an archival tumor tissue block or slides or if not available, undergo procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure
Ovarian Cancer Exclusion Criteria for UPLIFT:
* Low-grade, clear cell, endometrioid, mucinous, carcinosarcoma, germ-cell, mixed histology, or stromal tumors
* Prior treatment with mirvetuximab soravtansine or another ADC containing an antitubulin payload
* Primary platinum-resistant disease, defined by a lack of response or by progression within 3 months after completing front-line, platinum-containing therapy.
* Participation in DES or EXP segments of this study
Ovarian Cancer Inclusion Criteria for QTc sub-study:
Note: patients must meet all UPLIFT cohort inclusion criteria in order to participate in the QTc sub-study
• Study patient has agreed to remain in the clinic for the additional QTc related study activities on the Day 1 of Cycle 1 and Cycle 3.
Ovarian Cancer Exclusion Criteria for QTc sub-study:
* Use of strong CYP450 3A inducers.
* Uncontrolled cardiac arrhythmias, for example, atrial fibrillation with a ventricular response at rest > 100 beats per minute. left bundle branch block (LBBB)
* Known abnormality of any cardiac valve (either stenosis or regurgitation) that is greater than moderate in severity.
* Subjects not in sinus rhythm at screening with HR >45- <100
* Any ECG abnormality that can interfere with the measurement of the QT interval
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/12/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/10/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
523
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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0
Royal Brisbane & Women's Hospital - Herston
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Recruitment hospital [2]
0
0
Alfred Hospital - Melbourne
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Recruitment hospital [3]
0
0
Royal Melbourne Hospital - Parkville
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Recruitment hospital [4]
0
0
Chris O'Brien Lifehouse Oncology - Camperdown
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Recruitment hospital [5]
0
0
St Vincent's Hospital The Kinghorn Cancer Centre - Darlinghurst
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Recruitment hospital [6]
0
0
St Vincent's Hospital (Melbourne) Cancer Centre - Fitzroy
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Recruitment hospital [7]
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0
The Canberra Hospital Cancer,Ambulatory & Community Health Service (CACHS) Bldg 19 - Garran
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Recruitment hospital [8]
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Royal Brisbane & Women's Hospital Clinical Research Unit - Herston
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Recruitment hospital [9]
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Cabrini Hospital Cabrini Haematology and Oncology Centre - Malvern
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Recruitment hospital [10]
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Perth Oncology - Mount Hospital - Perth
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Recruitment hospital [11]
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The Queen Elizabeth Hospital Haematology and Oncology Unit - Woodville
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Recruitment hospital [12]
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Monash Children's Hospital - Clayton
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Recruitment postcode(s) [1]
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0
4029 - Herston
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Recruitment postcode(s) [2]
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0
3004 - Melbourne
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Recruitment postcode(s) [3]
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0
3050 - Parkville
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Recruitment postcode(s) [4]
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NSW 2050 - Camperdown
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Recruitment postcode(s) [5]
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0
2010 - Darlinghurst
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Recruitment postcode(s) [6]
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0
3065 - Fitzroy
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Recruitment postcode(s) [7]
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2605 - Garran
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Recruitment postcode(s) [8]
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0
3144 - Malvern
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Recruitment postcode(s) [9]
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0
6000 - Perth
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Recruitment postcode(s) [10]
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SA 5011 - Woodville
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Recruitment postcode(s) [11]
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3168 - Clayton
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
North Carolina
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0
0
United States of America
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0
0
Oklahoma
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0
0
United States of America
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0
0
Pennsylvania
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0
0
United States of America
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0
0
Tennessee
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Country [5]
0
0
United States of America
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0
0
Texas
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0
0
United States of America
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0
0
Virginia
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0
0
United States of America
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0
0
Washington
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0
0
Argentina
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State/province [8]
0
0
Buenos Aires
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Country [9]
0
0
Argentina
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State/province [9]
0
0
Buenos Aries
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Country [10]
0
0
Austria
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0
0
Wels
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Country [11]
0
0
Belgium
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State/province [11]
0
0
Oost-Vlaanderen
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Country [12]
0
0
Belgium
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State/province [12]
0
0
Vlaams-Brabant
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Country [13]
0
0
Canada
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State/province [13]
0
0
Alberta
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Country [14]
0
0
Canada
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State/province [14]
0
0
Ontario
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Country [15]
0
0
Chile
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State/province [15]
0
0
Coquimbo
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Country [16]
0
0
Czechia
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State/province [16]
0
0
Ostrava
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Country [17]
0
0
France
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State/province [17]
0
0
Lyon
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Country [18]
0
0
France
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State/province [18]
0
0
Paris
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Country [19]
0
0
Germany
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State/province [19]
0
0
Baden-Wurttemberg
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Country [20]
0
0
Germany
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Israel
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Manchester
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Bruxelles
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Edegem
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Gent
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Brazil
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Salvador
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Varna
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Arras
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Ohio
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Caen
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Oregon
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Chambray Les Tours
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France
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Dijon
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France
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France
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France
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Nice
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Pessac
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Poitiers
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Reims
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Rennes
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Saint Etienne
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France
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TOULOUSE cedex 9
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Cork
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Torino
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Opole
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Iasi
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Ljubljana
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Kharkiv
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Kiev
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Ukraine
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Kyiv
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Ukraine
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Odesa
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Mersana Therapeutics
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Address
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Country
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Other collaborator category [1]
0
0
Commercial sector/industry
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Name [1]
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0
ADIR, a Servier Group company
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0
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0
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Ethics approval
Ethics application status
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Summary
Brief summary
First-in-human, Phase 1b/2 safety study of the antibody-drug conjugate (ADC) XMT-1536 (upifitamab rilsodotin) administered as an intravenous infusion once every four weeks. Patients with tumor types likely to express NaPi2b were enrolled in dose escalation. Patients with platinum-resistant ovarian cancer and non-small cell lung cancer (adenocarcinoma subtype) were enrolled in the expansion segment of this study. Patients with platinum-resistant, high-grade serous ovarian cancer were enrolled in the UPLIFT segment of this study. In addition to safety assessments, the pharmacokinetics of the drug were assessed along with ADC activity. A QTc sub-study was added for the UPLIFT cohort for a sub-set of sites.
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Trial website
https://clinicaltrials.gov/study/NCT03319628
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Trial related presentations / publications
Owen DH, Giffin MJ, Bailis JM, Smit MD, Carbone DP, He K. DLL3: an emerging target in small cell lung cancer. J Hematol Oncol. 2019 Jun 18;12(1):61. doi: 10.1186/s13045-019-0745-2. Bachet JB, Wyrwicz L, Price T, Cremolini C, Phelip JM, Portales F, Ozet A, Cicin I, Atlan D, Becquart M, Vidot L, Mounedji N, Van Cutsem E, Taieb J, Falcone A. Safety, efficacy and patient-reported outcomes with trifluridine/tipiracil in pretreated metastatic colorectal cancer: results of the PRECONNECT study. ESMO Open. 2020 Jun;5(3):e000698. doi: 10.1136/esmoopen-2020-000698. Ozet A, Dane F, Aykan NF, Yalcin S, Evrensel T, Ozkan M, Karabulut B, Ormeci MN, Atasev O, Vidot L, Cicin I. Safety and efficacy of trifluridine/tipiracil in previously treated metastatic colorectal cancer: PRECONNECT Turkey. Future Oncol. 2022 Sep;18(29):3267-3276. doi: 10.2217/fon-2022-0455. Epub 2022 Aug 30. Zaniboni A, Barone CA, Banzi MC, Bergamo F, Blasi L, Bordonaro R, Bartolomeo MD, Costanzo FD, Frassineti GL, Garufi C, Giuliani F, Latiano TP, Martinelli E, Personeni N, Racca P, Tamburini E, Tonini G, Besse MG, Spione M, Falcone A. Italian results of the PRECONNECT study: safety and efficacy of trifluridine/tipiracil in metastatic colorectal cancer. Future Oncol. 2021 Jun;17(18):2315-2324. doi: 10.2217/fon-2020-1278. Epub 2021 Mar 5.
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Public notes
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Contacts
Principal investigator
Name
0
0
Robert Burger, MD
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Address
0
0
Mersana Therapeutics
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0
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Phone
0
0
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Fax
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0
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Email
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0
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Contact person for public queries
Name
0
0
Jamie Barrett
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Address
0
0
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0
0
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Phone
0
0
617-715-8214
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Fax
0
0
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Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03319628