RP-6306 in Patients With Advanced Cancer

NCT05605509 | Completed Phase 2 DMC

• 1 other identifier: I243
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 6

Brief Summary

This study is being done to answer the following questions:

• Is the new drug, RP-6306, safe to use, and what effects does it have on cancer when given with standard treatment?
• If there are specific biomarkers, do patients have an improved response to treatment compared to those without the biomarker? This study is being done to find out if this approach is better or worse than the usual approach for this type of cancer. The usual approach is defined as care most people get for this type of cancer.

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (1)

• Response rate of RP-6306 in patients with selected cancers receiving standard agent

  2 years

Secondary Outcomes (2)

• Number and severity of adverse events

  2 years

• Explore the recommended dose of RP-6306

  2 years

Study Arms (4)

RP-6306 + Gemcitabine

ACTIVE COMPARATOR

Drug: RP-6306; Drug: Gemcitabine

RP-6306 + FOLFIRI

ACTIVE COMPARATOR

Drug: RP-6306; Drug: FOLFIRI Protocol

RP-6306 + Trastuzumab

ACTIVE COMPARATOR

Drug: RP-6306; Drug: Trastuzumab

RP-6306 + RP-3500

ACTIVE COMPARATOR

Drug: RP-6306; Drug: RP-3500

Interventions

Trastuzumab DRUG

standard doses q3weekly

RP-6306 + Trastuzumab

RP-3500 DRUG

Dose and schedule will be assigned at enrolment

Also known as: Camonsertib

RP-6306 + RP-3500

RP-6306 DRUG

Dose and schedule will be assigned at enrolment

Also known as: Lunresertib

RP-6306 + FOLFIRI; RP-6306 + Gemcitabine; RP-6306 + RP-3500; RP-6306 + Trastuzumab

Gemcitabine DRUG

Dose and schedule will be assigned at enrolment

RP-6306 + Gemcitabine

FOLFIRI Protocol DRUG

Irinotecan Leucovorin FU

RP-6306 + FOLFIRI

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically confirmed cancer, that is advanced/metastatic/recurrent or unresectable, for which no curative therapy exists, and be eligible for one or more of the open cohorts
• All patients must have a formalin fixed paraffin embedded tissue block (from primary or metastatic tumour) available and must have provided informed consent for the release of the block
• Presence of clinically and/or radiologically documented disease. All radiology studies must be performed within 21 days prior to enrollment
• Patients must be ≥ 18 years of age
• Patients must have an ECOG performance status of 0 or 1
• Patients must have a life expectancy of 3 months or longer
• Hemoglobin ≥ 90 g/L (exceptions may be granted for well compensated and asymptomatic patients).
• Abs neutrophils ≥ 1.5 x 10\^9/L; Platelets ≥ 100 x 10\^9/L
• Bilirubin ≤ 1.5 x UNL; AST ≤2.5 x UNL; ALT ≤ 5.0 x UNL; Serum creatinine ≤ 1.5 x UNL; Creatinine clearance ≥ 50 mL/min
• Patients must be able to swallow oral medications and have no known gastrointestinal disorders that may interfere with absorption (such as malabsorption)
• Patients must have had recovered (to at least grade 0 or 1) from all reversible toxicity related to prior chemotherapy or systemic therapy and have adequate washout longest of one of the following: two weeks; 5 half-lives for investigational agents; standard cycle length of standard therapies.
• Prior external beam radiation is permitted provided a minimum of 28 days (4 weeks) have elapsed between the last dose of radiation and date of enrollment. Exceptions may be made for low-dose, non-myelosuppressive radiotherapy after consultation with CCTG. Concurrent radiotherapy is not permitted
• Previous surgery is permitted provided that a minimum of 21 days (3 weeks) have elapsed between any major surgery and date of enrollment, and that wound healing has occurred
• Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to screening (if applicable)/enrollment in the trial to document their willingness to participate
• Protocol treatment is to begin within 2 working days of patient enrollment

You may not qualify if:

• Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for \> 2 years and which do not require ongoing treatment
• Patients with active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol
• Patients are not eligible if they have a known hypersensitivity to the study drug(s) or their components
• Prior use of WEE1 inhibitor or PKMYT1 inhibitor
• Patients with significant cardiac (including uncontrolled hypertension) or pulmonary disease, or active CNS disease or infection. Patients should have a LVEF ≥ 50%.
• Patients may not receive concurrent treatment with other anti-cancer therapy (other than bone-targeted therapy, if already taking and stable) or investigational agents while on protocol therapy
• Patients who have received growth factors within 28 days prior to initiation of dosing of RP-6306 or who will require treatment with growth factors throughout the duration of the trial
• Pregnant or breastfeeding women
• Patients with history of central nervous system metastases or spinal cord compression unless they have received definitive treatment, are clinically stable and do not require corticosteroids
• Patients with any medical condition that would impair the administration of oral agents including significant bowel resection, inflammatory bowel disease or uncontrolled nausea or vomiting
• Patients who cannot discontinue the use of proton pump inhibitors, strong CYP3A inhibitors or inducers.

Sponsors & Collaborators

• Canadian Cancer Trials Group: lead
• Repare Therapeutics: collaborator

Study Sites (6)

BCCA - Kelowna

Kelowna, British Columbia, V1Y 5L3, Canada

Location

BCCA - Vancouver

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location

London Health Sciences Centre Research Inc.

London, Ontario, N6A 5W9, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Interventions

Gemcitabine; IFL protocol; Trastuzumab

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Stephanie Lheureux

  University Health Network, Princess Margaret Hospital, Toronto ON Canada

  STUDY CHAIR

• Yvette Drew

  BCCA-Vancouver Cancer Centre, Vancouver BC Canada

  STUDY CHAIR

• Eric Chen

  University Health Network, Princess Margaret Hospital, Toronto ON Canada

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 4, 2022
• Study Start: May 24, 2023
• Primary Completion: November 14, 2025
• Study Completion: February 5, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)