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APG-115 in Combination With PD-1 Inhibitor in Patients With Advanced Liposarcoma or Advanced Solid Tumors

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 26, 2025 (before its estimated April 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Re-verified, no change to tracked fieldsv10
  2. Primary completion date: Apr 2024 to Apr 2026 Completion date: Jan 2025 to Jan 2027v9 Show 1 more changeShow less
    • Completion date: Jan 2025 to Jan 2027
  3. Start date: Jun 2, 2021 to May 26, 2021v8
  4. Re-verified, no change to tracked fieldsv7
  5. Enrollment target: 92 to 95v6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 2 to 3v5
  2. Study sites: 1 to 2v4
  3. Trial status: Not Yet Recruiting to Recruiting Enrollment target: 73 to 92 · Study sites: 0 to 1 · Start date changed from estimate of May 2021 to Jun 2, 2021v3 Show 3 more changesShow less
    • Enrollment target: 73 to 92
    • Study sites: 0 to 1
    • Start date changed from estimate of May 2021 to Jun 2, 2021
  4. Start date: Apr 2021 to May 2021v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Part 1 is a phase Ib standard "3 + 3" design, will be employed to determine the MTD of APG-115 by assessing the DLT of APG-115 in combination with PD-1 inhibitor(toripalimab) in advanced solid tumors. Part 2 is a Simon two-stage phase II study design. At RP2D of APG-115 in combination with toripalimab in advanced liposarcoma, approximately 34 patients will be treated with the combination until disease progression, unacceptable toxicity, or another discontinuation criterion is met.
Trial Details
NCT Number NCT04785196
Lead Sponsor Ascentage Pharma Group Inc.
Collaborators: Suzhou Yasheng Pharmaceutical Co., Ltd.
Conditions Liposarcoma, Advanced Solid Tumor
Enrollment 95 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov