Study of RP-6306 With FOLFIRI in Advanced Solid Tumors

NCT ID: NCT05147350

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-09
• Study Completion Date: 2025-02-12

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.

Detailed Description

To assess the safety and tolerability of RP-6306 in combination with FOLFIRI in patients with eligible, advanced solid tumors. Incidence and severity of treatment-emergent adverse events (TEAEs), laboratory assessments, vital signs, electrocardiograms (ECGs), and use of concomitant medications.

The Sponsor of the study has changed from 'Repare Therapeutics' to 'Debiopharm International SA' in the United States.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

RP-6306 (oral PKMYT1 inhibitor)

Intervention Type: DRUG

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

Interventions

RP-6306 (oral PKMYT1 inhibitor)

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

Intervention Type: DRUG

Other Intervention Names

FOLFIRI

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Repare Therapeutics

INDUSTRY

Sponsor Role: collaborator

Debiopharm International SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

#1019, UCLA, Westwood Cancer Center

Los Angeles, California, United States

#1022, Moffitt Cancer Center

Tampa, Florida, United States

#1008, Columbia University

New York, New York, United States

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

Houston, Texas, United States

#1013, The University of Utah, Huntsman Cancer Center

Salt Lake City, Utah, United States

# 2001, Princess Margaret Cancer Centre

Toronto, Ontario, Canada

# 5002, South Texas Accelerated Research Therapeutics

Madrid, , Spain

# 5003, Hospital Universitario HM Sanchinarro

Madrid, , Spain

# 3003, Sarah Cannon Research Institute

London, , United Kingdom

Countries

United States; Canada; Spain; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

RP-6306-03

Identifier Type: -

Identifier Source: org_study_id