Part 1 is the open label, dose-escalation phase Ib portion of the study to establish the maximum tolerated dose (MTD)/RP2D of APG-115 in combination with pembrolizumab. Four dose levels of APG-115 will be administered: 50 mg, 100 mg, 150 mg, and 200 mg. APG-115 will be administered orally every other day (QOD) for consecutive 2 weeks and 1 week off dosing as a cycle of 21 days (3 weeks), pembrolizumab will administrated with label dose.
Part 2 is a phase II study design, includes cohort A-F six arms. The patients will be treated with APG-115 at 150 mg QOD (RP2D) in combination with pembrolizumab until disease progression, unacceptable toxicity, or another discontinuation criterion is met.
A Phase Ib/II Study of APG-115 in Combination With Pembrolizumab in Patients With Unresectable or Metastatic Melanomas or Advanced Solid Tumors
Sponsor / Cooperative group:
Ascentage Pharma Group Inc