🏛️ Verified NIH Record • Updated 2024-08-16

APG-2575 Study of Safety, Tolerability ,PK/PD in Patients With Hematologic Malignancies (NCT03537482)

A Phase I Study of Safety, Tolerability, Pharmacokinetic and Pharmacodynamics Property of Orally Administered APG-2575 in Patients With Hematologic Malignancies

🟢 Recruiting Early Phase1 💊 Investigational Drug / Biologic Sponsor: Ascentage Pharma Group Inc.

🩺 Plain-English Summary (8th-Grade Level)

This is a multi-center, single-agent, open-label, Phase I study of APG-2575. The study consists of the dose escalation stage and the dose expansion stage.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (11 items) and avoid the listed exclusions (14 items).

Location: Mayo Clinic — Jacksonville, Florida

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria: Patients who meet any of the following exclusion criteria are not to be enrolled in this study:
  • Prior history of allogeneic cell transplant.
  • Subjects have been diagnosed with Burkitt's lymphoma, Burkitt-like lymphoma, or lymphoblastic lymphoma/leukemia.
  • Received chemotherapy within 14 days (42 days for nitrosoureas or mitomycin C) prior to entering the study.
  • Received biologic (\< 28 days), small molecule targeted therapies (\< 5 half-life) or other anti-cancer therapy within 21 days of study entry.
  • Radiation within 14 days of study entry, thoracic radiation within 28 days of study entry.
  • Has gastrointestinal conditions that could affect the absorption of APG-2575 in the opinion of the Investigator.
  • Has known active central nervous system (CNS) involvement.
  • Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to ≤ Grade 1 except alopecia or neuropathy.
  • Concurrent treatment with an investigational agent, 14 days for small molecular agents and/or 28 days for biologics treatment prior to the first dose of therapy.
  • Failure to recover adequately, as judged by the investigator, from prior surgical procedures. Patients with active wound healing, patients who have had major surgery within 28 days from study entry, and patients who have had minor surgery within 14 days of study entry.
  • Unstable angina, myocardial infarction, or a coronary revascularization procedure within 180 days of study entry.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (5 Sites)

  • Mayo Clinic — Jacksonville, Florida
  • Duke Unviersity — Durham, North Carolina
  • MDACC — Houston, Texas
  • St. Vincent Hospital — Fitzroy, Victoria
  • Epworth Healthcare — Richmond, Victoria

📞 Contact the Study Coordinator

Phone: (301) 520-5964

Email: Laura.Glass@ascentage.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗