Study of RP-6306 With FOLFIRI in Advanced Solid Tumors

NCT05147350 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: RP-6306-03
• Study Type: interventional
• Target: 38
• Locations: 4 countries
• Sites: 9

Brief Summary

The primary purpose of this study is to assess the safety and tolerability of RP-6306 with FOLFIRI in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD), identify a recommended phase 2 dose (RP2D) and preferred schedule, and assess preliminary anti-tumor activity.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Safety and Tolerability of RP 6306 in Combination With FOLFIRI

  Incidence of grade 3 and above Treatment Related Emergent Adverse Events (TRAEs)

  Start of treatment to 30 days post last dose. up to 1.5 years

• Recommended Phase 2 Dose (RP2D) and Schedule of RP-6306 in Combination With FOLFIRI

  Evaluation of dose-limiting toxicities (DLTs) at or below a frequency of 25%.

  During 28 days (2 cycles) from the initiation of the study treatment

Study Arms (1)

Phase 1: RP-6306 in combination with FOLFIRI Dose Escalation

EXPERIMENTAL

RP-6306 will be administered as oral capsules Multiple dose levels of RP-6306 (oral) and FOLFIRI (IV)

Drug: RP-6306 (oral PKMYT1 inhibitor)

Interventions

RP-6306 (oral PKMYT1 inhibitor) DRUG

RP-6306 (Oral) in combination with FOLFIRI (IV)

Also known as: FOLFIRI

Phase 1: RP-6306 in combination with FOLFIRI Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female and ≥18 years-of-age at the time of signature of the informed consent
• Confirmed advanced solid tumors resistant or refractory to standard treatment
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
• All patients must have locally advanced or metastatic CRC, GI, or esophageal cancer(s) and radiographic evidence of progressing disease.
• Measurable disease as per RECIST v1.1
• Submission of available tumor tissue or willingness to have a biopsy performed if safe and feasible
• Acceptable hematologic and organ function at screening
• Negative pregnancy test for women of childbearing potential at Screening and prior to first study drug.

You may not qualify if:

• Inability to swallow and retain oral medications.
• Chemotherapy or small molecule antineoplastic agent given within 21 days or \<5 half- lives, whichever is shorter, prior to first dose of study treatment.
• History or current condition, therapy, or laboratory abnormality that might confound the study results, or interfere with the patient's participation for the full duration of the study treatment.
• Patients who are pregnant or breastfeeding
• Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction or other reasons which, in the investigator's opinion, could compromise the participating patient's safety.
• Major surgery within 4 weeks prior to first study treatment dose.
• Uncontrolled, symptomatic brain metastases.
• Uncontrolled high blood pressure
• Active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS) related illness.
• Moderate or severe hepatic impairment
• Cardiac diseases currently or within the last 6 months as defined by New York Heart Association (NYHA) ≥Class 2
• Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.

Sponsors & Collaborators

• Debiopharm International SA: lead
• Repare Therapeutics: collaborator

Study Sites (9)

#1019, UCLA, Westwood Cancer Center

Los Angeles, California, 90095, United States

Location

#1022, Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

#1008, Columbia University

New York, New York, 10032, United States

Location

#1001, The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

#1013, The University of Utah, Huntsman Cancer Center

Salt Lake City, Utah, 84112, United States

Location

# 2001, Princess Margaret Cancer Centre

Toronto, Ontario, ON M5G 2M9, Canada

Location

# 5002, South Texas Accelerated Research Therapeutics

Madrid, Spain

Location

# 5003, Hospital Universitario HM Sanchinarro

Madrid, Spain

Location

# 3003, Sarah Cannon Research Institute

London, W1G 6AD, United Kingdom

Location

MeSH Terms

Interventions

IFL protocol

Results Point of Contact

• Title: Repare Therapeutics Medical Monitor
• Organization: Repare Therapeutics INC

clininfo@reparerx.com

857-340-5402

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose Escalation and expansion

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: December 7, 2021
• Study Start: August 9, 2022
• Primary Completion: February 12, 2025
• Study Completion: February 12, 2025
• Last Updated: December 5, 2025
• Results First Posted: August 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2); GB (1); CA (1); US (5)