Part 1 is the dose escalation of APG-115 in combination with label dose of pembrolizumab.
Part 2 is phase II design of APG-115 at recommended phase 2 dose (RP2D) in combination with
pembrolizumab in patients with programmed cell death protein 1 (PD-1)/programmed death-ligand
1 (PD-L1) refractory/relapsed melanoma or NSCLC, lung adenocarcinoma with STK11 mutation,
solid tumors with P53 WT and ATM mutation, P53 WT and MDM2 amplification liposarcomas,
PD-1/PD-L1 refractory/relapsed urothelial carcinoma without FGFR translocation mutation, and
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.
Unresectable or Metastatic Melanoma or Advanced Solid Tumors, Melanoma, Uveal Melanoma, Non Small Cell Lung Cancer, ATM Gene Mutation, P53 Mutation, MDM2 Gene Mutation, Liposarcoma, Urothelial Carcinoma, MPNST, Cutaneous Melanoma, Mucosal Melanoma, Malignant Peripheral Nerve Sheath Tumors, STK11 Gene Mutation
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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