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Trial Summary

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.

Acronym:

APG-115-US-002

ACTRN/NCT /ethics:

NCT03611868

Scientific title:

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

Trial & Patient Characteristics

Cancer TypeMelanoma & other skin, Other
Trial TypeTreatment
PhasePhase I, Phase II
Age Range12 Years and older
SexAll
Tumour Stream -
Cancer StageLocally Advanced, Metastatic or Widespread
Anticipated Start Date2018-07-29
Anticipated End Date2022-10-30

Participating Hospitals

HospitalFlinders Medical Centre
Clinical Trial CoordinatorHannah Adelson
EmailHannah.adelson@sa.gov.au
Phone08 8206 4835
Principal InvestigatorProfessor Chris Karapetis
Recruitment StatusRecruiting