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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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This is a multicenter, open-label study of CS1001 in combination with regorafenib in participants with advanced or refractory cancers. There will be a dose escalation portion in "allcomers"to find a suitable dose of regorafenib for combination use with CS1001. This study will also enroll participants with specific tumor types in the phase II part of the study to assess the efficacy, pharmacokinetics and safety of the combined regimen (RP2D of regorafenib + CS 1001)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase Ib arm | Experimental | arms 1. Phase Ib: advanced or refractory solid tumors; |
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| Phase II arm | Experimental | arms 2.Phase II: subjects with tumor of specific types |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CS1001 | Drug | One course will last 28 days. CS1001 will be intravenously administered every 4 weeks (Q4W). |
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| Measure | Description | Time Frame |
|---|---|---|
| Phase Ib (Safety Evaluation): Number of participants with adverse events | Baseline up to 90 days post last dose, up to 2 years | |
| Phase Ib (Safety Evaluation): Dose Limiting Toxicity (DLT) | Baseline up to 90 days post last dose, up to 2 years | |
| Phase II (Efficacy Expansion): Objective response rate (ORR) | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Phase Ib (Safety Evaluation): Objective response rate (ORR) | Up to 2 years | |
| Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Disease control rate (DCR) | Up to 2 years | |
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Inclusion Criteria:
Exclusion Criteria:
Other inclusion/exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ashford Cancer Centre Research | Kurralta Park | South Australia | 5037 | Australia |
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| ID | Term |
|---|---|
| C559147 | regorafenib |
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| Regorafenib | Drug | One course will last 28 days. Administration will be orally (p.o.) taken at different dose schemes. |
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| Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Progression Free Survival (PFS) |
| Up to 2 years |
| Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Duration of Response (DoR) | Up to 2 years |
| Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Overall Survival (OS) | Up to 2 years |
| Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Occurrence of anti-CS1001 antibody | From first dose to 30 days after last dose, up to 2 years |
| Phase II (Efficacy Expansion): : Number of participants with adverse events | Baseline up to 90 days post last dose, up to 2 years |
| Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Area under the plasma concentration-time curve (AUC)0-t of CS1001 | From first dose to 30 days after last dose, up to 2 years |
| Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Maximum plasma concentration (Cmax) of CS1001 | From first dose to 30 days after last dose, up to 2 years |
| Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Time to reach maximum plasma concentration (Tmax) of CS1001 | From first dose to 30 days after last dose, up to 2 years |
| Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Terminal elimination half-life (t1/2) of CS1001 | From first dose to 30 days after last dose, up to 2 years |
| Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Clearance at Steady State (CLss) of CS1001 | From first dose to 30 days after last dose, up to 2 years |
| Phase Ib (Safety Evaluation): Maximum plasma concentration (Cmax) of regorafenib | From first dose to 30 days after last dose, up to 2 years |
| Phase Ib (Safety Evaluation): Minimum plasma concentration (Cmin) of regorafenib | From first dose to 30 days after last dose, up to 2 years |