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APG-2449 in Patients With Advanced Solid Tumors

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv19
  2. Eligibility criteria shortened, about 16 wordsv18 See this version in full on ClinicalTrials.gov ↗
  3. Enrollment target: 150 to 165 Eligibility criteria shortened, about 6 wordsv17 Show 1 more changeShow less
    • Eligibility criteria shortened, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date: Jan 2025 to Dec 2027 Completion date: Feb 2025 to Jan 2028v16 Show 1 more changeShow less
    • Completion date: Feb 2025 to Jan 2028
  5. Re-verified, no change to tracked fieldsv15
Show 13 earlier versionsHide 13 earlier versions
  1. Study sites: 10 to 9 Eligibility criteria expanded, about 50 wordsv14 Show 1 more changeShow less
    • Eligibility criteria expanded, about 50 words

    See this version in full on ClinicalTrials.gov ↗

  2. Eligibility criteria expanded, about 38 wordsv13 See this version in full on ClinicalTrials.gov ↗
  3. Re-verified, no change to tracked fieldsv12
  4. Eligibility criteria shortened, about 2 wordsv11 See this version in full on ClinicalTrials.gov ↗
  5. Enrollment target: 100 to 150 Primary completion date: May 2022 to Jan 2025 · Study sites: 8 to 10 · Completion date: May 2023 to Feb 2025 · 1 morev10 Show 4 more changesShow less
    • Primary completion date: May 2022 to Jan 2025
    • Study sites: 8 to 10
    • Completion date: May 2023 to Feb 2025
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  6. Study sites: 7 to 8v9
  7. Re-verified, no change to tracked fieldsv8
  8. Study sites: 1 to 7 Eligibility criteria expanded, about 177 wordsv7 Show 1 more changeShow less
    • Eligibility criteria expanded, about 177 words

    See this version in full on ClinicalTrials.gov ↗

  9. Enrollment target: 40 to 100 Primary completion date: May 2021 to May 2022 · Completion date: May 2022 to May 2023v6 Show 2 more changesShow less
    • Primary completion date: May 2021 to May 2022
    • Completion date: May 2022 to May 2023
  10. Collaborators expanded, about 5 wordsv5 See this version in full on ClinicalTrials.gov ↗
  11. 2 versions Re-verified since Jun 20, 2019, no change to tracked fieldsv3-v4
  12. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of May 2019 to May 27, 2019 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of May 2019 to May 27, 2019
    • Site details revised
  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.
Ascentage Pharma Group Inc.
29 trials monitored
See 2 trials at risk
Lung Cancer
4,057 trials monitored
See 217 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
2,932 trials monitored
See 157 trials at risk
Ovarian Cancer
1,245 trials monitored
See 80 trials at risk
and 2 more diseases
APG-2449 is a novel, orally active, multi-targeted tyrosine kinase inhibitor, which inhibits FAK, ALK, and ROS1 with nanomolar potencies. In preclinical studies, APG-2449 demonstrated potent antiproliferative activity in various cancer cell lines as a single agent. In combination treatment, APG-2449 enhanced anti-proliferative activities of several chemotherapeutic and targeted agents. It is indicated that APG-2449 may have a broad therapeutic potential for the treatment of human cancer as a single agent and in combination with other classes of anticancer drugs. APG-2449 is intended for the treatment of patients with advanced solid tumors. Upon completion of the Phase 1 dose escalation study to establish the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and/or recommended phase 2 dose (RP2D), several phase Ib/II studies will be implemented accordingly.
Trial Details
NCT Number NCT03917043
Lead Sponsor Ascentage Pharma Group Inc.
Collaborators: Suzhou Yasheng Pharmaceutical Co., Ltd.
Conditions Advanced Solid Cancer, Non Small Cell Lung Cancer, Esophageal Cancer, Ovarian Cancer, Malignant Pleural Mesothelioma
Enrollment 165 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov