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RP-3500 + Radiation Therapy for Cancer

Phase 1 & 2
Recruiting
Led By Nancy Lee, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed malignancy with at least one metastatic lesion amenable to radiotherapy in bone, visceral, and soft tissue
Ability to swallow capsules and retain oral medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing the safety of a new drug, RP-3500, when given with palliative radiotherapy to people with metastatic solid tumors and a mutation of the ATM gene.

Who is the study for?
This trial is for adults with metastatic solid tumors and a specific ATM gene mutation who can swallow pills, have good organ function, and haven't had certain prior treatments. They must not be pregnant or breastfeeding, agree to use contraception, and are expected to live more than 6 months.Check my eligibility
What is being tested?
The study tests the safety of RP-3500 combined with palliative external beam radiotherapy (EBRT) in treating metastatic solid tumor cancer. Researchers aim to find the highest dose of RP-3500 that causes few or mild side effects.See study design
What are the potential side effects?
Potential side effects may include typical reactions from radiation therapy such as fatigue, skin irritation at the treatment site, nausea, and other symptoms depending on treated area. Side effects from RP-3500 are being studied but could involve issues related to its action on DNA repair.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has spread and can be treated with radiation.
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I can swallow pills without difficulty.
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I am 18 years old or older.
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I can take care of myself and perform daily activities.
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My cancer has a mutation in the ATM gene.
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My kidney and liver functions are within the required ranges.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Therapeutic radiology procedure
Disease transmission

Trial Design

1Treatment groups
Experimental Treatment
Group I: RP-3500 in Combination With Standard Radiation TherapyExperimental Treatment2 Interventions
Patients with metastatic cancers with identified mutations in ATM will be enrolled. All patients will receive a standard palliative RT (4Gy x 5 fractions) on Days 1-5 in combination with RP-3500 on Days 1-5. In the first phase of the study, a 3+3 study design will be used to identify a safe dose of RP-3500 (starting at 80 mg QD) in combination with palliative RT.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,931 Previous Clinical Trials
597,633 Total Patients Enrolled
Repare TherapeuticsIndustry Sponsor
8 Previous Clinical Trials
986 Total Patients Enrolled
Nancy Lee, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
12 Previous Clinical Trials
2,024 Total Patients Enrolled

Media Library

External Beam Radiotherapy (EBRT) Clinical Trial Eligibility Overview. Trial Name: NCT05566574 — Phase 1 & 2
Solid Tumors Research Study Groups: RP-3500 in Combination With Standard Radiation Therapy
Solid Tumors Clinical Trial 2023: External Beam Radiotherapy (EBRT) Highlights & Side Effects. Trial Name: NCT05566574 — Phase 1 & 2
External Beam Radiotherapy (EBRT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05566574 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are in this trial at most?

"That is accurate. The clinicaltrials.gov website has information revealing that this trial is looking for 74 patients at 7 different locations. The study was originally posted on 9/30/2022 and updated on the same date."

Answered by AI

In how many different medical clinics is this clinical study being run today?

"At the moment, patients are being recruited from 7 different locations for this clinical trial. If you enroll, it is advised that you choose a location nearest to you in order to cut down on travel expenses and time."

Answered by AI

Are there any patients who have yet to enroll in this clinical trial?

"Yes, the clinical trial is still open to new participants. The original posting was on September 30th, 2020 and there have been no changes since then. They are looking for 74 individuals spread out over 7 sites."

Answered by AI
~37 spots leftby Sep 2025