A Phase 1a/1b Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Advanced Malignant Tumors

CIBI322A101

This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in cancer subjects who failed standard treatment.

2020-07-31

2023-08-28

2023-08-28

Completed

Early phase I

94

Inclusion Criteria: 1. Histologically/cytologically confirmed, locally advanced unresectable or metastatic tumors. 2. At least one evaluable lesion. 3. Male or female subject above 18 years old, no more than 75 years old. 4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 or 1. 5. Must have adequate organ function Exclusion Criteria: 1. Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein. 2. 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 3. Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies. 4. 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.) 5. Subjects who have a history of blood transfusion within 2 weeks prior to the study.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 94, 'type': 'ACTUAL'}}

2023-10-10