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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03319628
Registration number
NCT03319628
Ethics application status
Date submitted
17/10/2017
Date registered
24/10/2017
Date last updated
25/01/2023
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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Non Small Cell Lung Cancer Metastatic
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - upifitamab rilsodotin
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
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.
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
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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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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]
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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]
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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]
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60 minutes prior to first dose, up to 26 hours after Cycle 3 dose
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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/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
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
31/12/2024
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Actual
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Sample size
Target
444
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Austin Health - Olivia Newton John Cancer Center - Heidelberg
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Recruitment hospital [2]
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Blacktown Road - Blacktown
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Chris OBrien Lifehouse - Camperdown
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Chris O'Brien Lifehouse - Camperdown
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Royal Brisbane and Women's Hospital - Herston
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Peter MacCallum Cancer Center - Melbourne
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Recruitment hospital [7]
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Icon Cancer Centre South Brisbane - South Brisbane
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Recruitment postcode(s) [1]
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- Heidelberg
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Recruitment postcode(s) [2]
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2148 - Blacktown
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2050 - Camperdown
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- Camperdown
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4029 - Herston
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3000 - Melbourne
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Recruitment postcode(s) [7]
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4201 - South Brisbane
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Recruitment outside Australia
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Poland
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Bialystok
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Poland
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Gdansk
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Country [74]
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Poland
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Gdynia
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Country [75]
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Poland
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Poznan
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Country [76]
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Spain
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Badalona
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Spain
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Barcelona
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Spain
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El Palmar
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Spain
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Jaen
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Valencia
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Sweden
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Lund
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United Kingdom
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Cambridge
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United Kingdom
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Glasgow
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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State/province [88]
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Northwood
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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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Ethics approval
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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 are being enrolled in the UPLIFT segment
of this study. In addition to safety assessments, the pharmacokinetics of the drug will be
assessed along with ADC activity. A QTc sub-study has been added for the UPLIFT cohort for a
sub-set of sites.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03319628
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Leslie DeMars, MD
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Mersana Therapeutics
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Fax
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Contact person for public queries
Name
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Jamie Barrett
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Phone
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617-715-8214
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03319628
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