A Study of APG-115 in Combination With Pembrolizumab in Patients With Metastatic Melanomas or Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03611868|
Recruitment Status : Recruiting
First Posted : August 2, 2018
Last Update Posted : July 12, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Unresectable or Metastatic Melanoma or Advanced Solid Tumors Melanoma Uveal Melanoma P53 Mutation MDM2 Gene Mutation MPNST Cutaneous Melanoma Mucosal Melanoma Malignant Peripheral Nerve Sheath Tumors||Drug: APG-115+Pembrolizumab||Phase 1 Phase 2|
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. 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. 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. Part 2 includes patients with programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) refractory/relapsed melanoma and MPNST.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||224 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib/II Study of APG-115 in Combination With Pembrolizumab in Patients With Unresectable or Metastatic Melanomas or Advanced Solid Tumors|
|Actual Study Start Date :||August 29, 2018|
|Estimated Primary Completion Date :||December 30, 2022|
|Estimated Study Completion Date :||October 31, 2023|
Experimental: APG-115+Pembrolizumab open label, two-part phase Ib/II
single arm dose escalation and dose expansion
dose escalation of APG-115 in combination with label dose of pembrolizumab, Four dose levels of APG-115 will be tested: 50, 100, 150, and 200 mg. APG-115 will be administrated orally every other day (QOD) for consecutive 2 weeks (ie. dosed at Day 1, 3, 5, 7, 9, 11, and 13), with one week dosing off as 3-weeks a cycle. Pembrolizumab is administrated following FDA approved label dose, i.e., 200 mg intravenous infusion at Day 1 of every 3 weeks as a cycle.
Other Name: Keytruda
- Maximum Tolerated Dose [ Time Frame: 21 days ]Part I is to assess the safety and tolerability of APG-115 by assessing the dose-limiting toxicity (DLT) of APG-115 in combination with pembrolizumab. End points included: Incidence of DLTs during the first 3 weeks of treatment of each dose cohort; Severity and frequency of any adverse event(s) (AE) and serious adverse event(s) (SAE) based on NCI CTCAE 5.0
- Recommended Phase II Dose [ Time Frame: 21 days ]Part I is aimed to generate data to select the recommended Phase II dose
- Overall Response Rate [ Time Frame: up to 12 months ]Phase II is to assess overall response rate of APG-115 in combination with pembrolizumab defined as the percentage of subjects with a best overall confirmed complete response (CR) or a partial response (PR) at any time as per RECIST 1.1
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03611868
|Contact: Angela Kaiser||301-509-0357||Angela.Kaiser@ascentage.com|
|Study Chair:||Yifan Zhai, MD, PhD||Ascentage Pharma Group Inc.|