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Advanced CancerPhase 2NCT05605509

RP-6306 in Patients With Advanced Cancer

A Phase 2 study testing RP-6306, Gemcitabine and FOLFIRI Protocol in people with Advanced Cancer, run by Canadian Cancer Trials Group at 6 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Cancer
What is being tested?
RP-6306, Gemcitabine and FOLFIRI Protocol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
6 sitesCanada
Study dates
24 May 2023to 5 Feb 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • Patients must be accessible for treatment and follow-up. Patients enrolled on this trial must be treated and followed at the participating centre
  • Women/men of childbearing potential must have agreed to use a highly effective contraceptive method.
  • Cohort-Specific Eligibility Criteria
  • Cohort A: Endometrial Cancer
  • Patients must have histologically confirmed diagnosis of high-grade serous endometrial cancer, that is advanced/metastatic/recurrent or unresectable, for which no curative therapy exists.
  • Patients must have abnormal TP53 on IHC/genomic testing*.
  • Patients must have had at least 1 prior line of platinum-based chemotherapy in any setting but may not have received prior gemcitabine therapy.
  • Cohort B1: HGSOC
  • Patients must have a histologically confirmed diagnosis of high-grade serous ovarian cancer/fallopian tube/primary peritoneal carcinoma (HGSOC) which is platinum-refractory per standard definitions.
  • Patients must have abnormal TP53 on IHC/genomic testing*.
  • Platinum refractory disease refers to patients with progressive disease on first-line platinum-based chemotherapy or progressive disease within 12 weeks of the last dose of first-line platinum-based therapy [Gynecologic Cancer Intergroup Consensus Recommendations 2022].
  • Cohort B2: Uterine Carcinosarcoma
  • Patients must have had at least 1 prior line of platinum-based chemotherapy but may not have received prior gemcitabine therapy.
  • Patients must have abnormal TP53 on IHC/genomic testing*.
  • Cohort B3: Ovarian Carcinosarcoma
  • Patients must have had at least 1 prior line of platinum-based chemotherapy but may not have received prior gemcitabine therapy.
  • Patients must have abnormal TP53 on IHC/genomic testing*.
  • Cohort B4: TNBC
  • Patients must have had at least 2 prior lines of therapy in the advanced setting.
  • Patients may not have received prior gemcitabine.
  • Cohort B5: PDAC
  • Patients must have prior FOLFIRINOX either in the palliative/advanced setting or have relapsed within 6 months of completing adjuvant or neoadjuvant FOLFIRINOX.
  • Patients may not have received prior gemcitabine.
  • Patients must have abnormal TP53 on IHC/genomic testing*.
  • Cohort B6: NSCLC
  • Patients must have received standard therapies including platinum combination chemotherapy, standard salvage chemotherapy, immunotherapy, and targeted therapies as applicable.
  • Patients may not have received prior gemcitabine.
  • Cohort C1: Colorectal Cancer
  • Patients must have histologically confirmed diagnosis of colorectal cancer, that is advanced/metastatic/recurrent or unresectable, for which no curative therapy exists.
  • Patients must have both a RAS mutation (KRAS) and a TP53 mutation based on local testing*.
  • Patients must be eligible to receive FOLFIRI; patients homozygous for UGT1A1*28 allele are not eligible
  • Patients must have had at least 1 prior line of cytotoxic chemotherapy with FOLFOX, either as:
  • 1st line therapy for metastatic disease, or
  • recurrence within 6 months of completion of adjuvant FOLFOX.
  • Cohort D1: HER-2+ Gastroesophageal Cancer
  • Patients must have histologically confirmed diagnosis of gastroesophageal cancer, that is advanced/metastatic/recurrent or unresectable, for which no curative therapy exists.
  • Tumour must be HER-2+ (IHC 3+, or FISH+) and have CCNE1 amplification
  • Cohort F1: Primary platinum refractory HGSOC
  • Patients must have a histologically confirmed diagnosis of high grade serous ovarian cancer/fallopian tube/primary peritoneal carcinoma (HGSOC) which is platinum refractory per standard definitions.
  • Patients must have one of the following for enrolment - Known CCNE1 amplification or deleterious mutations in either FBXW7 or PPP2R1A on local testing
  • Tumour designated as CCNE1 biomarker positive based on central testing (see Section 12.2)
  • Platinum refractory disease refers to patients with progressive disease on first line platinum-based chemotherapy, or progressive disease within 12 weeks of the last dose of first line platinum-based therapy [Gynecologic Cancer Intergroup Consensus Recommendations 2022].

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Canada6 sites

  • BCCA - Kelowna

    Kelowna, British Columbia, V1Y 5L3

  • Kingston Health Sciences Centre

    Kingston, Ontario, K7L 2V7

  • London Health Sciences Centre Research Inc.

    London, Ontario, N6A 5W9

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6

  • University Health Network

    Toronto, Ontario, M5G 2M9

  • BCCA - Vancouver

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

Official title: A Phase II Study of RP-6306 in Patients With Advanced Cancer

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.

Read the detailed description

RP-6306 is a PKMYT1 inhibitor. PKMYT1 protein kinase negatively regulates CDK1 via phosphorylation of threonine 14 (Thr14) and sequestration in the cytoplasm. RP-6306 has shown single-agent anti-tumour efficacy in several xenograft models with amplified CCNE1 in a dose-dependent manner. RP-6306 has synergistic effects in combination with gemcitabine in CCNE1-amplified/overexpressing models in vitro and in vivo

Conditions
Advanced Cancer
Being tested
RP-6306, Gemcitabine, FOLFIRI Protocol, Trastuzumab, RP-3500

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RP-6306Drug

    Also called Lunresertib

    Dose and schedule will be assigned at enrolment

  • GemcitabineDrug

    Dose and schedule will be assigned at enrolment

  • FOLFIRI ProtocolDrug

    Irinotecan Leucovorin FU

  • TrastuzumabDrug

    standard doses q3weekly

  • RP-3500Drug

    Also called Camonsertib

    Dose and schedule will be assigned at enrolment

Study groups in NCT05605509
Study groupRoleWhat they receive
RP-6306 + GemcitabineActive comparatorNot described
Receives: Drug: RP-6306; Drug: Gemcitabine
RP-6306 + FOLFIRIActive comparatorNot described
Receives: Drug: RP-6306; Drug: FOLFIRI Protocol
RP-6306 + TrastuzumabActive comparatorNot described
Receives: Drug: RP-6306; Drug: Trastuzumab
RP-6306 + RP-3500Active comparatorNot described
Receives: Drug: RP-6306; Drug: RP-3500

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 2 years

Secondary outcomes (2)

  1. Number and severity of adverse events

    Measured: 2 years

  2. Explore the recommended dose of RP-6306

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2022
  2. Study start24 May 2023
  3. Primary completion14 Nov 2025
  4. Study completion5 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05605509
Sponsor's protocol ID
I243
Status last verified
Feb 2026
First submitted
31 Oct 2022
Last updated
6 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RP-6306, Gemcitabine and FOLFIRI Protocol in people with Advanced Cancer, run by Canadian Cancer Trials Group at 6 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 57 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate of RP-6306 in patients with selected cancers receiving standard agent (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05605509.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.

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