Safety and Efficacy of IBI322 in Chinese Subjects With Advanced Malignant Tumors

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 cancer subjects who failed standard treatment.

Detailed Description
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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 approximately 38-60 subjects with advanced malignant solid tumors who failed the standard treatment. Phase Ib is dose expansion, and plans to enroll approximately 180 subjects with advanced malignant tumors.

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

Conditions
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Advanced Malignancies

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, 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 Criteria: 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.

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 DLT |  | 28 days | 
| Number of treatment related AEs |  | 90 days post last dose | 
| Number of patients with response |  | Last patient enrolled+24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameters: The area under the curve (AUC) |  | Up to 90 days post last dose | 
| PK parameters: Maximum concentration (Cmax) |  | Up to 90 days post last dose | 
| PK parameters: Time at which maximum concentration (Tmax) |  | Up to 90 days post last dose | 
| PK parameters: The half-life (t1/2) |  | Up to 90 days post last dose | 
| Positive rate of ADA and Nab |  | Up to 90 days post last dose | 
| Positive rate of Circulating Immune Complex |  | Up to last dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oncology