🏛️ Verified NIH Record • Updated 2025-12-11

A Study of RP-3500 in Combination With Standard Radiation Therapy in People With Solid Tumor Cancer (NCT05566574)

RP-3500 (ATRi) + External Beam Radiotherapy (EBRT) for the Palliative Treatment of Metastatic Disease

🔵 Active, Not Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: Memorial Sloan Kettering Cancer Center

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

The purpose of this study is to test the safety of the study drug, RP-3500 when given in combination with palliative external beam radiotherapy (EBRT) to people who have metastatic solid tumor cancer with a mutation of the ATM gene. The study researchers will do tests to find the highest dose of RP3500 that causes few or mild side effects.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (22 items) and avoid the listed exclusions (16 items).

Location: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activites) — Basking Ridge, 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:
  • Previous radiotherapy to the intended treatment site
  • Prior therapy with an ATR or DNA-dependent protein kinase (DNA-PK) inhibitor
  • Serious medical co-morbidities precluding radiotherapy
  • Pregnant or breast-feeding women
  • No other concurrent systemic therapy during the entire duration of protocol treatment. Patients can have other systemic treatments up until the start of protocol treatment. Patients can also have other systemic treatments after the completion of protocol treatments
  • Known hypersensitivity to any of the ingredients of RP-3500
  • Uncontrolled hypertension (systolic blood pressure \[BP\] ≥160 mmHg; diastolic BP ≥100 mmHg) despite adequate treatment prior to first dose of RP-3500
  • Patients with active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness. In equivocal cases, patients whose viral load is negative, may be eligible. HIV seropositive patients who are healthy and low risk for AIDS related outcomes could be considered eligible. Eligibility criteria for HIV positive patients should be evaluated and discussed, and will be based on current and past CD4 and T-cell counts, history (if any) of AIDS-defining conditions (eg, opportunistic infections), and status of HIV treatment
  • Moderate or severe hepatic impairment (ie, Child-Pugh class B or C)
  • History or presence of an abnormal ECG that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third-degree heart block, or recent history of myocardial infarction that in the opinion of the investigator will pose an increased risk of rhythm abnormalities
  • History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias such as structural heart disease (eg, severe left ventricular systolic dysfunction, left ventricular hypertrophy), coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing), clinically significant electrolyte abnormalities (eg, hypokalemia, hypomagnesemia, hypocalcemia), or family history of sudden unexplained death or long QT syndrome

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

📍 All Participating Trial Locations (7 Sites)

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activites) — Basking Ridge, New Jersey
  • Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown, New Jersey
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey
  • Memorial Sloan Kettering Cancer Center at Suffolk-Commack (All Protocol Activities) — Commack, New York
  • Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison, New York
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York

📞 Contact the Study Coordinator

Phone: (800) 525-2225

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 ↗