A Phase I Study of RP-3500 Alone or with Talazoparib in People with Advanced Solid Tumors with Certain Genetic Mutations

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Full Title

Phase 1/2a Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of RP-3500 Alone or in Combination with Talazoparib in Advanced Solid Tumors with ATR inhibitor Sensitizing Mutations

Purpose

The purpose of this study is to find the highest dose of the investigational drug RP-3500 that can be given alone and with talazoparib in patients with advanced solid tumors, including breast cancer, that contain certain mutations. RP-3500 inhibits ATR, a protein that helps repair damage to DNA. Changes (mutations) in DNA can cause cancer cells to grow quickly and out of control. When ATR is inhibited, cancer cells can’t repair themselves and they stop growing. 

Talazoparib inhibits PARP, another protein that helps repair DNA damage. It is already used to treat some patients with breast cancer. Both RP-3500 and talazoparib are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have an advanced solid tumor that contains a mutation in one of these genes: ATM, ATRIP, BRCA1, BRCA2, CDK12, CHTF8, FZR1, MRE11, NBN, PALB2, RAD17, RAD50, RAD51B, REV3L, RNAseH2A, RNAseH2B, or SETD2.
  • Patients should recover from the serious side effects of previous treatment before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Ezra Rosen at 646-888-6955.

Protocol

20-521

Phase

I/II

Investigator

Co-Investigators