A Phase I Study of RP-6306 to Treat Advanced Solid Tumors

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Full Title

Phase 1 Study of the PKMYT1 Inhibitor RP-6306 in Combination with Gemcitabine for the Treatment of Advanced Solid Tumors (MAGNETIC Study)

Purpose

The purpose of this study is to find the highest doses of the investigational drug RP-6306 and the standard chemotherapy gemcitabine that can be given together to treat advanced cancer. This drug combination will be assessed in people with advanced tumors that contain a mutation (genetic change) in the FBXW7 or PPP2R1A genes, or extra copies (“genetic amplification”) of the gene CCNE1. Moreover, patients’ tumors must continue to grow despite prior treatment.

RP-6306 blocks the protein PKMYT1, which plays a major role in the survival and growth of cancers with the genetic changes being studied in this clinical trial. Gemcitabine is used to treat many different types of cancer. It works by stopping cells from growing and dividing. RP-6306 is a capsule that is taken orally (by mouth) and gemcitabine is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have an inoperable or metastatic solid tumor that contains FBXW7 or PPP2R1A mutations or CCNE1 amplification.
  • Patients should recover from the serious side effects of prior therapies before receiving the study treatment.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

For more information about this study and to ask about eligibility, please contact the office of Dr. Ying Liu at 646-888-4946.

Protocol

21-464

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators