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.
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