Active — Not RecruitingPhase 1/2

A Study of APG-115 in as a Monotherapy or Combination With Pembrolizumab in Patients With Metastatic Melanomas or Advanced Solid Tumors

United States230 participantsStarted 2018-08-29

Plain-language summary

This study aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of APG-115, an MDM2 inhibitor, either alone or in combination with pembrolizumab, a programmed cell death protein-1 (PD-1) inhibitor, in patients with metastatic melanomas or advanced solid tumors. Our hypothesis is that restoration of the immune response concomitant to inhibition of the MDM2 pathway (which restores p53 functions) may promote cancer cell death, leading to effective anticancer therapy.

Who can participate

Age range12 Years

SexALL

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Inclusion criteria

✓. Measurable disease according to RECIST 1.1. Lesions situated in a previously irradiated area, or an area subject to other loco-regional therapy (e.g., intralesional injections) should be considered non-measurable
✓. ECOG performance status 0-2
✓. Cohort A: Histologically confirmed, unresectable or metastatic melanoma, and refractory or relapse after PD-1 antibody treatment and ineligible for other standard of care therapy per NCCN guideline (previous PD-1/PD-L1 antibody treatment not required for uveal melanoma)
✓. Cohort F: Histologically confirmed, metastatic or unresectable MPNST

What they're measuring

Maximum Tolerated Dose

Timeframe: 21 days

Recommended Phase II Dose

Timeframe: 21 days

Overall Response Rate

Timeframe: up to 12 months

Trial details

NCT IDNCT03611868

SponsorAscentage Pharma Group Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-30

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