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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI322 | Other | Single arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI322 | Biological | Recombinant anti-human CD47/PD-L1 bispecific antibody injection |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| WenBin Qian | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital Zhejiang University School of Medicine | Zhejiang | China |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| 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 |