A Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Hematologic Malignancy

Study Overview
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Brief Summary
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This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in subjects with hematologic malignancies who have failed standard treatment.

Detailed Description
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This Phase 1a/1b study will be conducted to evaluate the safety, tolerability, PK, PD, immunogenicity, and preliminary antitumor activity of IBI322 in China. Phase 1a is a dose escalation and plans to enroll approximately 39-102 subjects with hematologic malignancies who have failed standard treatments. Phase 1b is a dose expansion and plans to enroll approximately 80 subjects with hematologic malignancies.

Official Title
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A Phase I Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Hematologic Malignancy

Conditions
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Hematologic Malignancy

Intervention / Treatment
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* Biological: IBI322


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically/cytologically confirmed hematologic malignancy who failed the standard treatment At least one evaluable lesion Male or female 18 to 75 years old Eastern Cooperative Oncology Group Performance Status Performance Status (ECOG PS) 0-2 Must have adequate organ function Exclusion Criteria: Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein Previous exposure to chimeric antigen receptor T cell immunotherapy (CAR-T) Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies Use of anticoagulants and/or aspirin, or other non-steroidal anti-inflammatory drugs within 2 weeks prior to study start A history of blood transfusion within 2 weeks prior to study start

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: IBI322<br>Single arm | Biological: IBI322<br>* Recombinant anti-human CD47/PD-L1 bispecific antibody injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment related AEs | Safety | Up to 90 days post last dose | 
| Number of patients with response | Preliminary Efficacy | Last patient enrolled +24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK Parameters: The area under the curve (AUC) | Safety and Preliminary Efficacy | Up to 90 days post last dose | 
| PK Parameters: Maximum concentration (Cmax) | Safety and Preliminary Efficacy | Up to 90 days post last dose | 
| PK Parameters: Half-life (t1/2) | Safety and Preliminary Efficacy | Up to 90 days post last dose | 
| PK Parameters: Clearance (CL) | Safety and Preliminary Efficacy | Up to 90 days post last dose | 
| PK Parameters: Volume of Distribution (V) | Safety and Preliminary Efficacy | Up to 90 days post last dose | 
| Positive Rate of ADA and Nab | Safety and Preliminary Efficacy | Up to 90 days post last dose |