Status:
COMPLETED
Safety and Efficacy of IBI322 in Chinese Subjects With Advanced Malignant Tumors
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Advanced Malignancies
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in cancer subjects who failed standard treatment.
Detailed Description
Phase 1a/Ib study will be conducted to evaluate the tolerability, safety, PK, PD, immunogenicity and preliminary antitumor activity of IBI322 in China. Phase 1a is dose escalation and plans to enroll ...
Eligibility Criteria
Inclusion
- Histologically/cytologically confirmed, locally advanced unresectable or metastatic tumors.
- At least one evaluable lesion.
- Male or female subject above 18 years old, no more than 75 years old.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 or 1.
- Must have adequate organ function
Exclusion
- Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein.
- Previous exposure to any anti-programmed death receptor 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) /anti-programmed death ligand 2 (PD-L2) antibodies
- Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies.
- Patients who are on anticoagulants and /or require concomitant aspirin or other nonsteroids anti-inflammatory medications. Patients with a history of a bleeding diathesis (von Willebrand disease, end stage liver disease, hemophilia, etc.)
- Subjects who have a history of blood transfusion within 2 weeks prior to the study.
Key Trial Info
Start Date :
July 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2023
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT04328831
Start Date
July 31 2020
End Date
August 28 2023
Last Update
October 10 2023
Active Locations (1)
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1
Cancer hospital Chinese academy of Medical sciences
Beijing, China