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A Phase Ib/II Study of APG-115 in Combination With Pembrolizumab in Patients With Unresectable or Metastatic Melanomas or Advanced Solid Tumors
Ascentage Pharma Group Inc.
This trial has two parts. Part 1 (dose escalation) is seeking to establish the maximum tolerated dose (MTD)/RP2D of APG-115 in combination with pembrolizumab. Four dose levels of APG-115 will be administered: 50mg, 100mg, 150mg, and 200mg. 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 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.