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A Study of RP-3500 in Combination With Standard Radiation Therapy in People With Solid Tumor Cancer | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

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

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

NCT05566574•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed malignancy with at least one metastatic lesion amenable to radiotherapy. Bone, visceral, and soft tissue are eligible.
•Mutation in ATM (deleterious or VUS; somatic or germline; monoallelic or biallelic)
•* Note: Homozygous Deletion in the ATM gene will also be allowed
•ECOG performance status 0-2 or KPS equivalent
•Age ≥18 years
•Expected survival greater than 6 months
•Participant or Legally Authorized Representative (LAR) able to provide written informed consent
•Patients of reproductive potential must agree to practice an effective contraceptive method
•Ability to swallow capsules and retain oral medications
•Acceptable organ function at Screening, as evidenced by the following laboratory data:
+12 more criteria

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
+5 more criteria

Locations (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activites)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center at Suffolk-Commack (All Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

Key Dates

Start Date

September 30, 2022

Primary Completion Date

September 30, 2026

Completion Date

September 30, 2026

Last Updated

December 17, 2025

Enrollment

ACTUAL participants

Conditions

Solid TumorMetastatic Cancer

Interventions

RP-3500

DRUG

External Beam Radiotherapy (EBRT)

RADIATION

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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