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

CIBI322A105

The Phase Ia study was designed to evaluate the tolerability, safety, PK, PD, immunogenicity and primary resistance of single therapy tumor activity in subjects with advanced or metastatic solid tumors who have failed standard treatment. Phase Ib study was designed to evaluate the safety and initial efficacy of IBI322 in monotherapy or combination therapy in subjects with advanced or metastatic solid tumors. Investigators and sponsors determine the recommended dose of IBI322 for phase Ib based on PK, PD, safety and efficacy data obtained during phase Ia.

2021-07-21

2022-12-03

2023-08-25

Completed

Early phase I

61

Inclusion Criteria: 1. Histologically/cytologically confirmed, locally advanced unresectable or metastatic tumors. 2. Per RECIST1, at least one evaluable or measurable 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. Direct coombs test was positive or have history of hemolytic anemia. 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': 61, 'type': 'ACTUAL'}}

2023-09-06