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This first-in-human open-label, multicenter, dose-escalation and expansion study is designed to evaluate the safety, tolerability, and primary efficacy of IBI321 in participants with locally advanced, recurrent, or metastatic incurable tumors for whom standard therapy does not exist, has proven to be ineffective or intolerable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase Ia Dose-Escalation Stage: IBI321 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI321 | Drug | Several dose levels will be evaluated for IBI321 administered as a single agent. IBI321 will be given via IV infusion on Day 1 of each cycle until disease progression or loss of clinical benefit. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Dose-Limiting Toxicities (DLTs) | From Day 1 of Cycle 1 to Day 28 | |
| Percentage of Participants with Adverse Events (AEs), treatment-related AE (TRAE), immune-related AEs (irAE) and serious adverse event (SAE) per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 | From Day 1 to up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR)per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. | From Baseline until disease progression (up to 2 years) | |
| Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
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| From Baseline until disease progression (up to 2 years) |
| Duration of Response (DoR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. | From Baseline until disease progression (up to 2 years) |
| Overall Survival (OS) | From Baseline until disease progression (up to 2 years) |
| Area Under the Concentration-Time Curve (AUC) of IBI321 | From Day 1 up to 2 years |
| Maximum Serum Concentration (Cmax) of IBI321 | From Day 1 up to 2 years |
| Minimum Serum Concentration (Cmin) of IBI321 | From Day 1 up to 2 years |
| Clearance (CL) of IBI321 | From Day 1 up to 2 years |
| Percentage of Participants with Anti-Drug Antibodies (ADAs) and Neutralizing Antibody (Nab) to IBI321 | From Day 1 up to 2 years |