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

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 7, 2025 (before its estimated December 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Dec 30, 2024 to Dec 30, 2025 Trial status: Recruiting to Active, Not Recruiting · Completion date: Mar 30, 2025 to Dec 30, 2025 · Site details revised at 21 of 21 sitesv37 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Completion date: Mar 30, 2025 to Dec 30, 2025
    • Site details revised at 21 of 21 sites
  2. Enrollment target: 224 to 230 Study sites: 20 to 21 · Interventions: APG-115+Pembrolizumab (Drug) to Phase 1b: APG-115+pembrolizumab (Drug) · Eligibility criteria shortened, about 226 words · 2 morev36 Show 5 more changesShow less
    • Study sites: 20 to 21
    • Interventions: APG-115+Pembrolizumab (Drug) to Phase 1b: APG-115+pembrolizumab (Drug)
    • Eligibility criteria shortened, about 226 words
    • Study description shortened, about 40 words
    • Study title expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Dec 30, 2023 to Dec 30, 2024 Completion date: Mar 30, 2024 to Mar 30, 2025v35 Show 1 more changeShow less
    • Completion date: Mar 30, 2024 to Mar 30, 2025
  4. Primary completion date: Dec 30, 2022 to Dec 30, 2023 Completion date: Oct 31, 2023 to Mar 30, 2024v34 Show 1 more changeShow less
    • Completion date: Oct 31, 2023 to Mar 30, 2024
  5. Re-verified, no change to tracked fieldsv33
Show 31 earlier versionsHide 31 earlier versions
  1. Study sites: 19 to 20 Eligibility criteria shortened, about 169 words · Study description shortened, about 4 wordsv32 Show 2 more changesShow less
    • Eligibility criteria shortened, about 169 words
    • Study description shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  2. Site contacts updated at 1 of 19 sitesv31
  3. Site details revised at 1 of 19 sitesv30
  4. Enrollment target: 203 to 224 Study sites: 18 to 19 · Eligibility criteria expanded, about 2 wordsv29 Show 2 more changesShow less
    • Study sites: 18 to 19
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  5. Site contacts updated at 1 of 18 sitesv28
  6. Site details revised at 1 of 18 sitesv27
  7. Study sites: 17 to 18v26
  8. Study sites: 16 to 17 Primary completion date: Oct 30, 2022 to Dec 30, 2022 · Completion date: Aug 31, 2023 to Oct 31, 2023v25 Show 2 more changesShow less
    • Primary completion date: Oct 30, 2022 to Dec 30, 2022
    • Completion date: Aug 31, 2023 to Oct 31, 2023
  9. Site details revised at 2 of 16 sitesv24
  10. Completion date: Jan 31, 2023 to Aug 31, 2023v23
  11. Site contacts updated at 2 of 16 sitesv22
  12. Site contacts updated at 13 of 16 sitesv21
  13. Study sites: 15 to 16v20
  14. Study sites: 14 to 15v19
  15. Primary completion date: Sep 30, 2022 to Oct 30, 2022 Completion date: Dec 31, 2022 to Jan 31, 2023v18 Show 1 more changeShow less
    • Completion date: Dec 31, 2022 to Jan 31, 2023
  16. Site contacts updated at 1 of 14 sitesv17
  17. Enrollment target: 143 to 203 Eligibility criteria expanded, about 69 words · Study description expanded, about 4 wordsv16 Show 2 more changesShow less
    • Eligibility criteria expanded, about 69 words
    • Study description expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  18. Primary completion date: Dec 31, 2021 to Sep 30, 2022 Study sites: 15 to 14 · Completion date: Feb 15, 2022 to Dec 31, 2022v15 Show 2 more changesShow less
    • Study sites: 15 to 14
    • Completion date: Feb 15, 2022 to Dec 31, 2022
  19. Study sites: 14 to 15v14
  20. Site details revised at 1 of 14 sitesv13
  21. Study sites: 13 to 14 Start date: Sep 19, 2018 to Aug 29, 2018v12 Show 1 more changeShow less
    • Start date: Sep 19, 2018 to Aug 29, 2018
  22. Enrollment target: 67 to 143 Primary completion date: Sep 15, 2020 to Dec 31, 2021 · Study sites: 12 to 13 · Completion date: May 15, 2021 to Feb 15, 2022 · 3 morev11 Show 6 more changesShow less
    • Primary completion date: Sep 15, 2020 to Dec 31, 2021
    • Study sites: 12 to 13
    • Completion date: May 15, 2021 to Feb 15, 2022
    • Start date: Sep 18, 2018 to Sep 19, 2018
    • Eligibility criteria expanded, about 609 words
    • Study description shortened, about 101 words

    See this version in full on ClinicalTrials.gov ↗

  23. Collaborators expanded, about 5 wordsv10 See this version in full on ClinicalTrials.gov ↗
  24. 2 versions Re-verified since Jul 22, 2020, no change to tracked fieldsv8-v9
  25. Study sites: 7 to 12v7
  26. Study sites: 3 to 7v6
  27. Study sites: 1 to 3v5
  28. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Sep 15, 2018 to Sep 18, 2018 · Site details revisedv4 Show 2 more changesShow less
    • Start date changed from estimate of Sep 15, 2018 to Sep 18, 2018
    • Site details revised
  29. Study site revisedv3 See this version in full on ClinicalTrials.gov ↗
  30. Study title shortened, about 4 wordsv2 See this version in full on ClinicalTrials.gov ↗
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03611868
Lead Sponsor Ascentage Pharma Group Inc.
Collaborators: Merck Sharp & Dohme LLC
Conditions Unresectable or Metastatic Melanoma or Advanced Solid Tumors, Melanoma, Uveal Melanoma, P53 Mutation, MDM2 Gene Mutation, Cutaneous Melanoma, Mucosal Melanoma, Malignant Peripheral Nerve Sheath Tumors (MPNST)
Enrollment 230 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov