* RP-6306-03
Research type
Research Study
Full title
Phase 1 Study of the PKMYT1 Inhibitor RP-6306 in Combination With FOLFIRI for the Treatment of Advanced Solid Tumors (MINOTAUR Study)
IRAS ID
1004699
Contact name
Louisa Vangsted-Rees
Contact email
Sponsor organisation
Repare Therapeutics
Eudract number
2021-006582-38
Clinicaltrials.gov Identifier
Research summary
This study combines RP-6306 with FOLFIRI. RP-6306 inhibits an enzyme (called PKMYT1) that is necessary for normal cell growth. RP-6306 can thereby stop certain cancer cells from growing. FOLFIRI is a common used cancer treatment regimen (a group of drugs), that works by stopping cancer cells from growing and dividing. The combination treatment is expected to have a better effect on stopping the growth of cancer cells with a specific genetic change. Therefore, patients with advanced cancer with a specific genetic change will be selected for this study.
This study will test:
- How safe RP-6306 and FOLFIRI are when given together at different doses and on different schedules.
- How well RP-6306 and FOLFIRI work together to shrink cancer in the body.This study is divided into 2 parts (Module 1a and Module 1b). 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.
At screening, and after signed consent, patients must provide a tumor sample to test whether their tumor has the specific genetic change. Eligible patients start treatment until disease progression or another reason for discontinuation, such as investigators decision, or unacceptable side effects. Patients will also be asked to undergo a fresh tumor biopsy prior to treatment and on-treatment to examine protein markers in the tumor. Also, blood will be drawn to assess circulating tumor DNA in the blood. Regular tumor imaging assessments will be performed to measure how the patient’s cancer is responding to the study drug. Safety will be monitored through side effects, vital signs, laboratory assessments, ECGs and use of concomitant medications throughout the study. After treatment discontinuation patient’s safety is monitored for up to 12 months. The study will last approximately 2.5 years.
REC name
North East - York Research Ethics Committee
REC reference
22/NE/0163
Date of REC Opinion
29 Apr 2022
REC opinion
Further Information Favourable Opinion