Dose-escalation Study of APG-1387 and Toripalimab in Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 108
Summary
- Conditions
- Advanced Solid Tumor
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This study will be conducted in two phases. In phase Ib, the safety and efficacy of different dose levels of APG-1387 in combination with 240 mg toripalimab will be explored to determine the recommended Phase 2 dose (RP2D) of APG-1387 in combination therapy, both administered as a 30-minute intraven...
This study will be conducted in two phases. In phase Ib, the safety and efficacy of different dose levels of APG-1387 in combination with 240 mg toripalimab will be explored to determine the recommended Phase 2 dose (RP2D) of APG-1387 in combination therapy, both administered as a 30-minute intravenous (IV) infusion. The following proposed doses of APG-1387 are to be evaluated: 20,30, or 12mg (in case no DLT occur in high dose levels, 12mg may be initiated for further exploration to determine RP2D comprehensively.) The Phase II portion, will compromise 3 cohorts of 29-31 patients. The 3 cohorts will include the following: Colorectal cancer Nasopharyngeal carcinoma Non-small cell lung cancer A Simon's 2-stage design will be used for each of the cohorts in colorectal cancer, nasopharyngeal carcinoma and non-small cell lung cancer. A predefined analysis will be performed in the first stage, and failure to achieve the prespecified efficacy will halt enrollment to avoid futile treatment.
Tracking Information
- NCT #
- NCT04284488
- Collaborators
- Not Provided
- Investigators
- Study Director: Yifan Zhai, M.D., Ph.D. Ascentage Pharma Group Inc.
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