MYTHIC Study
Research type
Research Study
Full title
Phase 1 Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of RP-6306 Alone or in Combination with RP-3500 in Patients with Advanced Solid Tumors (MYTHIC Study)
IRAS ID
1009374
Contact name
Samuel Bonilla
Contact email
Sponsor organisation
Repare Therapeutics
Clinicaltrials.gov Identifier
Research summary
The purpose of this research study is to:
•Test how safe RP-6306 is at different doses and dosing schedules
•Test how safe RP-6306 in combination with RP-3500 is at different doses and schedules.
•Test how well RP-6306 works in shrinking cancer in the body
•Test how well RP-6306 in combination with RP-3500 works to shrink cancer in the body.
•Assess whether food affects the way RP-6306 moves through the body.RP-6306 and RP-3500 are investigational drugs, which means that they have not been approved by any (global or European) regulatory authorities. Both drugs being studied are new drugs that are taken by mouth. RP-6306 inhibits a protein called PKMYT1 and RP-3500 is an ATR inhibitor which are designed to stop the growth of certain cancer cells. This is the first time RP-6306 alone or in combination with RP-3500 is being given to humans.
Patients with advanced solid tumours harbouring specific mutations that are expected to be sensitive to RP-6306 and RP-3500.
This is a first-in-human Phase 1 study divided into 2 parts (Module 1 and Module 2). The modules test different doses and schedules of the study drugs. The optimal dose/schedule identified will establish a recommended phase 2 dose (RP2D) for further testing. In the UK, patients will be recruited into Module 2 only.REC name
London - Chelsea Research Ethics Committee
REC reference
24/LO/0125
Date of REC Opinion
6 Mar 2024
REC opinion
Further Information Favourable Opinion