🏛️ Verified NIH Record • Updated 2025-03-27

Study to Evaluate IMP9064 as a Monotherapy or in Combination in Patients With Advanced Solid Tumors (NCT05269316)

A First-in-human, Phase 1/2, Open-label, Multi-center, Dose-escalation and Dose-expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of the ATR Inhibitor IMP9064 Monotherapy and in Combination With PARP Inhibitor Senaparib in Patients With Advanced Solid Tumors

🟢 Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: Impact Therapeutics, Inc.

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

This is a Phase 1/2, multicenter, open-label study to evaluate the safety and efficacy of IMP9064 as monotherapy or in combination with PARP inhibitor Senaparib in patients with advanced solid tumors

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (13 items) and avoid the listed exclusions (30 items).

Location: Hackensack University Medical Center PARTNER — Hackensack, New Jersey

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:
  • Known history of hypersensitivity to any components of the study drug.
  • Any investigational or approved systemic cancer therapy (including chemotherapy, immunotherapy, hormonal therapy and herbal/alternative therapies with anti-cancer indications, or targeted therapy) administered within 28 days or 5 half-lives, whichever is shorter, before the first dose of study drug.
  • Any previous treatment-related toxicities have not recovered, i.e. to ≤ Grade 1, as evaluated by NCI-CTCAE version 5.0 or baseline, except alopecia and anemia. Patients with chronic Grade 2 toxicities which are well managed and stable may be eligible per the discretion of the investigator after the discussion with the Sponsor and medical monitor, e.g., Grade 2 chemotherapy-induced neuropathy.
  • Primary tumor in CNS, or active or untreated CNS metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are clinically stable for at least 28 days and have no evidence of new or enlarging brain metastases and no requirements for high-dose corticosteroids 14 days prior to dosing with study drug. Patients on low dose corticosteroids (\< 20 mg prednisone or equivalent per day) may participate.
  • Clinically significant cardiovascular condition, including:
  • History of congestive heart failure (New York Heart Association \[NYHA\] Class \> 2)
  • History of unstable angina
  • New-onset angina or myocardial infarction within the 6 months prior to the first dose of study drug
  • New onset of atrial fibrillation, supraventricular arrhythmia, or ventricular arrhythmia within the 6 months prior to the first dose of study drug and requiring treatment or intervention. History of atrial fibrillation, supraventricular arrhythmia, or ventricular arrhythmia will be allowed provided the condition is stably controlled.
  • History or presence of an abnormal ECG that, in the Investigator's opinion, is clinically meaningful (including QTcF \> 470 msec for females, QTcF \> 450 msec for males by Fridericia formula at screening, pacemaker installation or previous diagnosis of congenital long QT syndrome).
  • Patients who have undergone a major surgery or have undergone a radical radiotherapy within 28 days prior to the first dose of study drug or have undergone a palliative radiotherapy within 14 days prior to the first dose of study drug, or have used a radioactive drug (Strontium, Samarium, etc.) within 56 days prior to first dose of study drug.

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

📍 All Participating Trial Locations (8 Sites)

  • Hackensack University Medical Center PARTNER — Hackensack, New Jersey
  • Mount Sinai — New York, New York
  • Greenville Hospital System University Medical Center (ITOR) — Greenville, South Carolina
  • Mary Crowley Cancer Research Centers — Dallas, Texas
  • Blacktown Hospital — Blacktown, New South Wales
  • Linear Clinical Research Limited — Nedlands,
  • Beijing Cancer Hospital — Beijing, Beijing Municipality
  • National Taiwan University Hospital — Taipei,

📞 Contact the Study Coordinator

Phone: +86-021-68411121

Email: xiangna.chen@impacttherapeutics.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.

More studies in Solid Tumor

Explore by condition: All Solid Tumor clinical trials

💡 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 ↗