Dose-escalation Study of APG-1387 and Toripalimab in Solid Tumors
brief summary
An ascending dose study in patients with solid tumors to evaluate the safety, tolerability, pharmacodynamics and efficacy of APG-1387 in combination with toripalimab. A phase II study of 3 cohorts will be included.
detailed 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 intravenous (IV) infusion. The following proposed doses of APG-1387 are to be evaluated: 20,30, or 45mg .
The Phase II portion, will compromise 3 cohorts of 15-25 patients.
The 3 cohorts will include the following:
* Colorectal cancer * Nasopharyngeal carcinoma * Non-small cell lung cancer with PD-1 antibody refractory or relapse.
official title
A Phase Ib/II Clinical Study to Evaluate the Efficacy and Safety of APG-1387 in Combination With Toripalimab in Patients With Advanced Solid Tumors