A Study of APG-115 in Combination With Pembrolizumab in Patients With Metastatic Melanomas or Advanced Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 67
Summary
- Conditions
- MPNST
- ATM Gene Mutation
- Cutaneous Melanoma
- Liposarcoma
- Malignant Peripheral Nerve Sheath Tumors
- MDM2 Gene Mutation
- Melanoma
- Urothelial Carcinoma
- Mucosal Melanoma
- Non -Small Cell Lung Cancer
- Unresectable or Metastatic Melanoma or Advanced Solid Tumors
- P53 Mutation
- STK11 Gene Mutation
- Uveal Melanoma
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 12 years and 125 years
- Gender
- Both males and females
Description
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 othe...
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.
Tracking Information
- NCT #
- NCT03611868
- Collaborators
- Merck Sharp & Dohme Corp.
- Investigators
- Study Chair: Yifan Zhai, MD, PhD Ascentage Pharma Group Inc.
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