Active — Not RecruitingPhase 1/2

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

United States49 participantsStarted 2022-09-30

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Serum creatinine ≤1.5 × upper limit of normal (ULN) or calculated creatinine clearance ≥60 mL/min using the Cockcroft-Gault equation or by 24-hour urine collection
✓. Total bilirubin ≤1.5 × ULN or \<3.0 × ULN if known Gilbert's disease
✓. Serum albumin ≥2.5 g/dL
✓. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN unless liver metastases are present and thought to be a reason for AST/ALT elevation, in which case they must be ≤5 × ULN
✓. No red blood cell or platelet transfusions or growth factors within 7 days of the first dose of RP-3500
✓. Hemoglobin ≥9.5 g/dL
✓. ANC ≥1700 cells/mm\^3
✓. Platelet count ≥130,000 cells/mm\^3

What they're measuring

Phase I - Safety and Tolerability of RP-3500 in combination with radiation therapy

Timeframe: 2 years

Phase II - Assess 6 month local control rate of patients with pathogenic ATM who received RP-3500 and palliative RT

Timeframe: 2 years

Trial details

NCT IDNCT05566574

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

View on ClinicalTrials.gov More Solid Tumor trials