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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/NCT05290597
Registration number
NCT05290597
Ethics application status
Date submitted
9/01/2022
Date registered
22/03/2022
Date last updated
8/09/2022
Titles & IDs
Public title
A Phase 1, Open-label, Multicenter, Dose Escalation Study of IBI363 (PD1-IL2m) in Subjects With Advanced Solid Malignancies or Lymphomas
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Scientific title
A Phase 1, Open-label, Multicenter, Dose Escalation Study of IBI363 (PD1-IL2m) in Subjects With Advanced Solid Malignancies or Lymphomas
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Secondary ID [1]
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CIBI363A101
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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:
Solid Malignancies or Lymphomas
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - IBI363
Experimental: IBI363 - Single arm
Other interventions: IBI363
a mutated IL-2 cytokine fused to an anti-PD-1 antibody to combine IL-2 pathway stimulation with checkpoint blockade.
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Intervention code [1]
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Other interventions
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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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Incidence of serious adverse events (SAEs), treatment-emergent AEs (TEAEs) and immune-related AEs (irAEs)
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Assessment method [1]
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An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is an important medical event that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. A TEAE will be defined as any new AE that begins, or any pre-existing condition that worsens in severity, after at least 1 dose of study treatment has been administered. irAEs will be assessed.
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Timepoint [1]
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up to 90 days after the last administration
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Primary outcome [2]
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Number of participants with abnormality in vital signs
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Assessment method [2]
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Blood pressure, pulse, respiratory rate, and temperature will be assessed.
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Timepoint [2]
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up to 90 days after the last administration
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Primary outcome [3]
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Number of participants with abnormality in hematology parameters
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Assessment method [3]
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Blood samples will be collected to evaluate hemoglobin, mean corpuscular volume (MCV), white blood cell (WBC) count, platelets, 5-part differential white cell count, mean platelet volume and coagulation factors including international normalized ratio (INR), activated partial thromboplastin time (aPTT) and prothrombin time (PT)
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Timepoint [3]
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up to 90 days after the last administration
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Primary outcome [4]
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Number of participants with abnormality in clinical chemistry parameters
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Assessment method [4]
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Blood samples will be collected to evaluate sodium, potassium, calcium, magnesium, chloride, glucose, creatinine, urea or blood urea nitrogen (BUN), bicarbonate, amylase, bilirubin, alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total protein, albumin, lactate dehydrogenase and lipase.
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Timepoint [4]
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up to 90 days after the last administration
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Primary outcome [5]
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Number of participants with abnormality in routine urinalysis parameters
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Assessment method [5]
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Urine samples will be collected to evaluate specific gravity, leucocyte esterase, nitrite, blood, bilirubin, protein, glucose, ketones and urobilinogen.
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Timepoint [5]
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up to 90 days after the last administration
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Primary outcome [6]
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Number of participants with abnormality in ECG parameters
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Assessment method [6]
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12-lead ECG will be obtained using an ECG machine. Participants will be in supine or a semi-recumbent position (about 30 degrees of elevation) and rested for approximately 2 minutes before ECGs are recorded.
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Timepoint [6]
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up to 90 days after the last administration
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Primary outcome [7]
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Number of dose-limiting toxicity (DLT)
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Assessment method [7]
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Incidence of dose-limiting toxicity (DLT) events
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Timepoint [7]
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28 days during the first 4-week cycle
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Secondary outcome [1]
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maximum concentration (Cmax)
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Assessment method [1]
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PK parameters to be evaluated for IBI363 including maximum concentration (Cmax) will be determined when appropriate.
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Timepoint [1]
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Up to 2 years
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Secondary outcome [2]
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area under the curve (AUC)
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Assessment method [2]
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PK parameters to be evaluated for IBI363 including area under the curve (AUC) will be determined when appropriate.
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Timepoint [2]
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Up to 2 years
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Secondary outcome [3]
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clearance (CL)
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Assessment method [3]
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PK parameters to be evaluated for IBI363 including area under the curve (AUC) will be determined when appropriate.
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Timepoint [3]
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Up to 2 years
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Secondary outcome [4]
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half-life (t1/2) of IBI363
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Assessment method [4]
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PK parameters to be evaluated for IBI363 including volume of distribution (V) will be determined when appropriate.
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Timepoint [4]
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Up to 2 years
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Secondary outcome [5]
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Objective response rate (ORR)
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Assessment method [5]
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To evaluate the preliminary antitumor activity of IBI363
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Timepoint [5]
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Up to 2 years
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Secondary outcome [6]
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time to response (TTR)
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Assessment method [6]
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To evaluate the preliminary antitumor activity of IBI363
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Timepoint [6]
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Up to 2 years
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Secondary outcome [7]
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duration of response (DoR)
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Assessment method [7]
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To evaluate the preliminary antitumor activity of IBI363
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Timepoint [7]
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Up to 2 years
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Secondary outcome [8]
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disease control rate (DCR)
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Assessment method [8]
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To evaluate the preliminary antitumor activity of IBI363
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Timepoint [8]
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Up to 2 years
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Secondary outcome [9]
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progression-free survival (PFS)
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Assessment method [9]
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To evaluate the preliminary antitumor activity of IBI363
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Timepoint [9]
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Up to 2 years
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Secondary outcome [10]
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6-month and 1-year PFS rate per RECIST v1.1 for subjects with solid tumors, and per Lugano 2014 for subjects with lymphomas
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Assessment method [10]
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To evaluate the preliminary antitumor activity of IBI363
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Timepoint [10]
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Up to 2 years
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Secondary outcome [11]
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Overall survival (OS)
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Assessment method [11]
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To evaluate the preliminary antitumor activity of IBI363
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Timepoint [11]
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through study completion, an average of 1 year
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Secondary outcome [12]
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survival rates (6-month and 1-year)
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Assessment method [12]
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To evaluate the preliminary antitumor activity of IBI363
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Timepoint [12]
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Up to 2 years
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Secondary outcome [13]
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The incidence of ADA and NAb of IBI363
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Assessment method [13]
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Each subject will be tested for anti-drug (IBI363) antibody (ADA), and ADA-positive serum samples will continue to be tested for neutralizing antibodies (NAb).
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Timepoint [13]
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Up to 2 years
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Eligibility
Key inclusion criteria
1. Male or female subjects, = 18 years
2. Subjects with a documented (histologically- or cytologically-proven) solid tumor
malignancy that is locally advanced or metastatic; subjects with documented lymphomas
3. Subjects with a malignancy (solid tumor or lymphoma) that is currently not amenable to
surgical intervention due to either medical contraindications or non-resectability of
the tumor
4. Subjects who are refractory to or intolerant to existing therapy(ies) known to provide
clinical benefit Note: Subjects may have received and failed prior therapy with a
PD-1/PD-L1 inhibitor and be considered eligible for this trial.
5. Subjects with measurable or non-measurable disease according to RECIST v1.1 or
standard criteria for lymphoma (Lugano 2014)
6. Subjects, both male and female, who are either not of childbearing potential or who
agree to use a highly effective method of contraception during the study beginning
within 2 weeks prior to the first dose and continuing until 6 months after the last
dose of study drug
7. Subjects with the ability to understand and give written informed consent for
participation in this trial, including all evaluations and procedures as specified by
this protocol
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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
1. Women who are pregnant or lactating, or intending to become pregnant before, during,
or within 6 months after the last dose of study drug. Women of childbearing potential
(WOCBP) or fertile men with WOCBP partner(s), not using and not willing to use a
highly effective method of contraception.
2. Subjects with history of or known active seizure disorder, brain metastases, spinal
cord compression, or carcinomatous meningitis, or new evidence of brain or
leptomeningeal disease.
3. Subjects with:
- Active thrombosis, or a history of deep vein thrombosis (DVT) or pulmonary
embolism (PE) within 4 weeks prior to first administration of study drug unless
adequately treated and considered by the Investigator to be stable.
- Active uncontrolled bleeding or a known bleeding diathesis.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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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
Single group
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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
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
22/08/2022
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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
31/08/2024
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Actual
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Sample size
Target
84
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Southern Medical Day Care Centre - Wollongong
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Recruitment postcode(s) [1]
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2500 - Wollongong
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Innovent Biologics (Suzhou) Co. Ltd.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a Phase 1, open-label, multicenter, dose-escalation study designed to evaluate the
safety, tolerability, and DLTs to establish the maximum tolerated dose (MTD) or maximum
administered dose (MAD), and the RP2D of sequential doses of IBI363 (study drug) in subjects
with advanced, refractory solid malignancies or lymphomas.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05290597
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Morteza Aghmesheh
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Address
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Southern Medical Day Care Centre
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Min Luo
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Address
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Country
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Phone
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00861087412310
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Fax
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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/NCT05290597
Download to PDF