Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is open-label, multicenter, Phase Ib study is designed to evaluate the Primary Efficacy and Safety of IBI321 Monotherapy or Combination Therapy in participants with advanced solid tumors.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI321 in advanced solid tumors | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI321 | Drug | IBI321 at a dose no higher than RP2D, D1 IV Q3W. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators. | From Baseline until disease progression (up to 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS), According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators. | From Baseline until disease progression (up to 2 years) | |
| Overall Survival (OS) | From Day 1 to up to 2 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Wu | Contact | 18117822381 | yang.wu@innoventbio.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Cancer Hospital | Changsha | Hunan | 410013 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Percentage of Participants with Adverse Events (AEs) per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 | From Day 1 to 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) to IBI321 | From Day 1 up to 2 years |
| Percentage of Participants with Neutralizing Antibody (Nab) to IBI321 | From Day 1 up to 2 years |