Study on RP-3500 with Radiation Therapy for People with Solid Tumor Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05566574

Provider View

This clinical trial is testing the safety of a new drug, RP-3500, when used with radiation therapy in people with solid tumor cancer that has spread and has a specific ATM gene mutation. Researchers aim to find the highest dose of RP-3500 that causes only mild side effects.

Patient Parameters

Program Overview

The study is designed to evaluate the safety of combining a new drug, RP-3500, with radiation therapy in patients who have solid tumors that have spread to other parts of the body and have a mutation in the ATM gene. The goal is to determine the highest dose of RP-3500 that can be given with few or mild side effects.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of cancer with at least one tumor that can be treated with radiation.
  • Have a mutation in the ATM gene.
  • Be in good overall health with an ECOG performance status of 0 to 2.
  • Be 18 years or older.
  • Have an expected survival of more than 6 months.
  • Be able to provide written informed consent.
  • Agree to use effective birth control if of reproductive potential.
  • Be able to swallow capsules and take oral medications.
  • Have acceptable organ function based on specific blood tests:
    • Serum creatinine within normal limits or adequate kidney function.
    • Total bilirubin within normal limits, or higher if known Gilbert's disease.
    • Serum albumin at least 2.5 g/dL.
    • Liver enzymes (AST and ALT) within normal limits, or higher if liver metastases are present.
  • Have acceptable blood cell counts:
    • No recent blood transfusions or growth factors.
    • Hemoglobin at least 9.5 g/dL.
    • Neutrophil count at least 1700 cells/mm³.
    • Platelet count at least 130,000 cells/mm³.
  • Have resolved any side effects from previous treatments to baseline or mild levels.
  • Women of childbearing potential must have a negative pregnancy test before starting the study.
  • Men and women must agree to use contraception during the study and for 6 months after the last dose of the study drug.

Exclusion Criteria

  • Have had previous radiation therapy to the area intended for treatment.
  • Have had prior treatment with certain types of cancer drugs (ATR or DNA-PK inhibitors).
  • Have serious medical conditions that prevent radiation therapy.
  • Be pregnant or breastfeeding.
  • Cannot have other cancer treatments during the study, but can have them before or after.
  • Have an allergy to any ingredients in RP-3500.
  • Have uncontrolled high blood pressure despite treatment.
  • Have active, uncontrolled infections, including hepatitis B, hepatitis C, or HIV, unless well-managed.
  • Have moderate or severe liver problems.
  • Have a history of significant heart problems or abnormal heart rhythms.
  • Be taking medications that affect heart rhythms.
  • Have conditions that prevent following the study protocol.
  • Be taking certain medications that interact with RP-3500.
  • Have specific genetic mutations in the ATM gene.

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