Study of RP-6306 With Gemcitabine in Advanced Solid Tumors

NCT05147272 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: RP-6306-02
• Study Type: interventional
• Target: 67
• Locations: 3 countries
• Sites: 11

Brief Summary

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

Conditions

Adult Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Number of Patients With of Treatment-related Adverse Event Data Per CTCAE v5.0 Criteria to Determine Safety and Tolerability of RP-6306 in Combination With Gemcitabine.

  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

• Number of Dose Limiting Toxicities, as Defined Per Protocol, That Occur During the First Cycle (21 Days) of Treatment at Each Dose Level

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

  During 21 days from the initiation of the study treatment (C1D1)

Study Arms (1)

Phase 1 Dose Escalation

EXPERIMENTAL

Multiple dose levels of RP-6306 and gemcitabine

Drug: RP-6306 (oral PKMYT1 inhibitor)

Interventions

RP-6306 (oral PKMYT1 inhibitor) DRUG

RP-6306 in combination with gemcitabine

Also known as: Gemcitabine (IV)

Phase 1 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 informed consent.
• ECOG Performance status 0 or 1.
• Locally advanced or metastatic resistant or refractory solid tumors.
• Submission of available tumor tissue at screening or willingness to have a biopsy performed if safe and feasible.
• Measurable disease as per RECIST v1.1.
• Ability to swallow and retain oral medications.
• Acceptable hematologic and organ function at screening.
• Negative pregnancy test (serum) for women of childbearing potential (WOCBP) at Screening.
• Resolution of all toxicities of prior therapy or surgical procedures.
• Life expectancy ≥12 weeks after the start of the treatment

You may not qualify if:

• Chemotherapy or small molecule antineoplastic agent given within 21 days or \<5 half- lives, whichever is shorter, prior to first dose of study drug.
• 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.
• Known sensitivity to any of the ingredients of RP-6306 or gemcitabine.
• 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 dose of RP-6306 and gemcitabine.
• Uncontrolled, symptomatic brain metastases.
• Uncontrolled hypertension.
• Moderate or severe hepatic impairment
• 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

• Repare Therapeutics: collaborator
• Debiopharm International SA: lead

Study Sites (11)

# 1018, Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

# 1019, UCLA, Westwood Cancer Center

Los Angeles, California, 90095, United States

Location

# 1017, Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

# 1022, Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

# 1023, START Midwest

Grand Rapids, Michigan, 49546, United States

Location

# 1016, Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

# 1008, Columbia University

New York, New York, 10032, United States

Location

# 1004, Memorial Sloan Kettering Cancer Institute

New York, New York, 10065, United States

Location

# 1010, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

# 2001, Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2C1, Canada

Location

# 3003, Sarah Cannon Research Institute

London, United Kingdom

Location

MeSH Terms

Interventions

Gemcitabine

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

Module 1a and 1b was conducted. However, Module 1c and 1d were not conducted, and the study was terminated early by the sponsor/company

Results Point of Contact

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

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 10, 2021
• First Posted: December 7, 2021
• Study Start: December 16, 2021
• Primary Completion: August 28, 2024
• Study Completion: August 28, 2024
• Last Updated: December 5, 2025
• Results First Posted: October 16, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); US (9); CA (1)