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

Full Title

Phase 1/1b Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of RP-6306 Alone or in Combination with RP-3500 or Debio 0123 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).

Who Can Join

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.