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The primary purpose of this trial is to assess the tolerability and safety of CHS-1000 alone and in combination with toripalimab-tpzi in participants with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Single Agent CHS-1000 | Experimental |
| |
| Part B: Combination Agents CHS-1000 + Toripalimab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHS-1000 | Biological | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-Emergent Adverse Events (TEAEs) | Up to approximately 27 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) | Up to approximately 27 months | |
| Area Under the Concentration-time Curve (AUC) | Up to approximately 27 months | |
| Terminal Half-life (t1/2) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined inclusion and exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandy Paige, Senior Director, Clinical Operations | Contact | 800-794-5434 | spaige@coherus.com |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
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| Toripalimab | Biological | Specified dose on specified days |
|
|
| Up to approximately 27 months |
| Number of Participants with Antidrug Antibodies | Up to approximately 27 months |
| Investigator-assessed Objective Response Rate (ORR) | Up to approximately 27 months |
| Duration of Response (DoR) | Up to approximately 27 months |
| Disease Control Rate (DCR) | Up to approximately 27 months |
| Time to Response (TTP) | Up to approximately 27 months |
| Progression-free Survival (PFS) | Up to approximately 27 months |
| Landmark PFS Rate | Month 6, Month 12 |