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Phase 1b: APG-115+pembrolizumab

Phase 2

Unresectable or Metastatic Melanoma or Advanced Solid Tumors | Small molecule | Oncology |Ascentage Pharma Group International - American Depository Shares|Last Updated: Aug 7, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment230
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03611868A Study of APG-115 in as a Monotherapy or Combination With Pembrolizumab in Patients With Metastatic Melanomas or Advanced Solid TumorsPHASE2 ACTIVE NOT_RECRUITING 230Aug 29, 2018Dec 30, 2025Aug 7, 202521 United States, United States +19
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Study Design & Arms
AllocationNA
MaskingNONE
PurposeTREATMENT
Interventions
NameTypeDescription
Phase 1b: APG-115+pembrolizumabDRUGdose 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 administrateddose escalation of APG-115 in combination with label dose of pembrolizumab, Fourfour 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 there are cycles every 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. Phase II: Combination of APG-115 at 150 mg (RP2D) and pembrolizumab or APG-115 monotherapy alone.
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT03611868studyFirstPostDate: changed