A Phase I Study of RP-6306 to Treat Advanced Solid Tumors with Certain Genetic Changes

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Full Title

Phase 1 Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of RP-6306 in Patients with Advanced Solid Tumors (MYTHIC Study)

Purpose

The purpose of this study is to find the highest dose of the investigational drug RP-6306 that can be used in advanced solid tumors containing certain genetic changes and which have come back or continued to grow despite prior treatment. 

RP-6306 blocks the protein PKMY1, which plays a major role in the survival and growth of cancers with the genetic changes being studied in this clinical trial. RP-6306 is 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 a locally advanced or metastatic solid tumor that has come back or continued to grow despite prior treatment.
  • Participants’ tumors must contain a mutation in the FBXW7 or PPP2R1A genes or extra copies of the CCNE1 gene.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people age 12 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Alison Schram at 646-888-5388.

Protocol

21-303

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators