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

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.