A Phase 1 Study of RP-3467 Alone and With Olaparib in People With Solid Tumors Having Certain Genetic Changes

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Full Title

Phase 1 Trial of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Activity of RP-3467 Alone and in Combination with Olaparib in Participants with Advanced Solid Tumors (POLAR Trial)

Purpose

Researchers want to find the best dose of RP-3467 to give alone and with olaparib in people with solid tumors. The people in this study have advanced solid tumors containing certain genetic changes.

RP-3467 is a type of drug called a polymerase-theta inhibitor. Polymerase-theta is an enzyme designed to repair damaged DNA in cancer cells. By blocking this enzyme, polymerase-theta inhibitors can prevent cancer cells from repairing their DNA. This leads to a buildup of damaged DNA in the cancer cells, possibly causing them to die.

If you join this study, you will get RP-3467 alone or with olaparib. Both drugs are taken orally (by mouth).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have advanced ovarian, pancreatic, breast, or prostate cancer that keeps growing even after treatment.
  • Have a mutation (genetic change) in the BRCA1, BRCA2, PALB2, or RAD51B/C/D genes or have homologous recombination deficiency.
  • Have recovered from the serious side effects of prior anti-cancer treatments before getting the study therapy.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call 646-888-4226. 

Protocol

24-316

Phase

Phase I (phase 1)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06560632