Recurrent Ovarian CancerPhase 1GyneRepNCT06107868
Phase 1 Study of RP-6306 With Carboplatin and Paclitaxel in TP53 Ovarian and Uterine Cancer
A Phase 1 study testing RP-6306, Carboplatin and Paclitaxel in people with Recurrent Ovarian Cancer and Recurrent Uterine Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This is a phase 1 study to evaluate investigational drug RP-6306 in combination with carboplatin and paclitaxel in patients with TP53 mutated ovarian or uterine cancer. The dose escalation part of the study will determine the maximum tolerated dose (MTD) and recommended Phase 2 Dose (RP2D) and schedule of RP-6306 in… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Ovarian Cancer, Recurrent Uterine Cancer, Metastatic Cancer
- What is being tested?
- RP-6306, Carboplatin and Paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- 20 Mar 2024to 30 Sep 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Females ≥18 years old at the time of signature of the consent form.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 28 days prior to enrollment.
- All patients must have histologically proven, locally advanced or metastatic recurrent ovarian and uterine cancer. Patients will be eligible only if available curative therapy does not exist.
- Ovarian and uterine cancer should be high-grade and TP53 abnormal by immunohistochemistry or TP53 mutated by genomic profiling.
- Patients must be eligible for re-challenge carboplatin and paclitaxel.
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- Patient must have archival tissue available for molecular profiling.
- Measurable disease as per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 at the time of enrollment.
- Ability to comply with the protocol and study procedures.
- Acceptable study required organ function at screening
- Acceptable study required hematologic function at screening
- Negative pregnancy test (serum) for women of child-bearing potential (WOCBP) at screening. WOCBP who are sexually active and their partners must agree to use a highly effective form of contraception throughout their participation during the study and for 6 months after the last dose of study treatment.
- Resolution of all toxicities of prior therapy or surgical procedures to baseline or Grade 1 (except for neuropathy, hypothyroidism requiring medication, and alopecia, which must have resolved to Grade ≤2).
- Any prior radiation must have been completed at least 7 days prior to the start of study treatment, and patients must have recovered from any acute adverse effects prior to the start of study treatment.
- Life expectancy ≥12 weeks after the start of the treatment according to the Investigator's judgment.
Who cannot join
- 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 (such as transfusion-dependent anemia or thrombocytopenia), 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, carboplatin and paclitaxel. Patients are eligible if pre-medications with steroids previously controlled sensitivity and patient was able to receive treatment.
- Patients who are unable to swallow oral medications.
- Prior treatment with a WEE1 inhibitor or PKMYT1 inhibitor.
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- Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction (such as ascites, coagulopathy, or encephalopathy), or other reasons which, in the Investigator's opinion, could compromise the participating patient's safety, or interfere with or compromise the integrity of the study outcomes.
- Major surgery within 4 weeks prior to first dose of study treatment.
- Uncontrolled, symptomatic brain metastases. Patients with previously treated brain metastases may participate provided the metastases are stable, they have no evidence of new or enlarged brain metastases, and they are clinically stable and off steroids for at least 7 days prior to study treatment.
- Uncontrolled hypertension despite adequate treatment prior to first dose of study treatment.
- Gastrointestinal disorders that may significantly interfere with absorption of the study medication by Investigator's assessment.
- Active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B virus, hepatitis C virus, known human immunodeficiency virus (HIV), or AIDS-related illness. In equivocal cases, patients whose viral load is negative may be eligible. HIV seropositive patients who are healthy and low risk for AIDS-related outcomes could be considered eligible.
- Moderate or severe hepatic impairment (ie, Child-Pugh Class B or C) at the time of registration.
- Any of the following cardiac diseases currently or within the last 6 months as defined by New York Heart Association (NYHA) ≥Class 2:
- Unstable angina pectoris
- Congestive heart failure
- Acute myocardial infarction
- Conduction abnormality not controlled with pacemaker or medication
- Significant ventricular or supraventricular arrhythmias (patients with chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible)
- Clinically relevant electrolyte abnormalities
- Current treatment with medications that are well-known to prolong the QT interval.
- Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.
- Patients who are receiving strong CYP3A inhibitors or inducers within 14 days prior to first dose of study treatment, investigational therapy or anticancer agents, or antiviral therapies that are sensitive CYP3A substrates.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of the PKMYT1 Inhibitor RP-6306 in Combination With Carboplatin and Paclitaxel for the Treatment of Recurrent TP53 Ovarian and Uterine Cancer
This is a phase 1 study to evaluate investigational drug RP-6306 in combination with carboplatin and paclitaxel in patients with TP53 mutated ovarian or uterine cancer. The dose escalation part of the study will determine the maximum tolerated dose (MTD) and recommended Phase 2 Dose (RP2D) and schedule of RP-6306 in combination with carboplatin and paclitaxel and the dose expansion will further assess the safety and tolerability as well as determine the preliminary efficacy of RP-6306 in combination with carboplatin and paclitaxel.
- Being tested
- RP-6306, Carboplatin, Paclitaxel
- Medical subject headings
- Ovarian Neoplasms, Uterine Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RP-6306Drug
RP-6306 is a selective inhibitor of PKMYT1 kinase. RP-6306 is an investigational agent.
CarboplatinDrug
Carboplatin is an antineoplastic agent.
PaclitaxelDrug
Paclitaxel is an antineoplastic agent.
| Study group | Role | What they receive |
|---|---|---|
| Part A - Dose Escalation | Experimental | RP6306, 40 mg orally, twice a day, continuously or on Days 1 to 3, for 1 or 2 weeks, every 21-day cycle.
Carboplatin, AUC 5 intravenously, on Day 1 of every 21-day cycle.
Paclitaxel, 175 mg/m2 intravenously, on Day 1 of every 21-day cycle. Receives: Drug: RP-6306; Drug: Carboplatin; Drug: Paclitaxel |
| Part B - Dose Expansion | Experimental | RP6306, 40 mg orally at the best schedule determined in Part A.
Carboplatin, AUC 5 intravenously, on Day 1 of every 21-day cycle.
Paclitaxel, 175 mg/m2 intravenously, on Day 1 every 21-day cycle. Receives: Drug: RP-6306; Drug: Carboplatin; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of dose-limiting toxicities (DLTs) at Dose Level 1
Measured: 21 days
Frequency of dose-limiting toxicities (DLTs) at Dose Level 2
Measured: 21 days
Frequency of dose-limiting toxicities (DLTs) at Dose Level -1
Measured: 21 days
Frequency of dose-limiting toxicities (DLTs) at Dose Level -2
Measured: 21 days
Secondary outcomes (7)
Incidence of treatment-emergent adverse events (TEAEs)
Measured: 4 years
Progression-free survival
Time from the first day of study treatment to disease progression.
Measured: 6 months
Objective response rate
Proportion of patients with confirmed complete response (CR) or partial response (PR)
Measured: 4 years
Disease Control Rate
Proportion of patients with a confirmed best response of CR or PR, or stable disease
Measured: At least 4 months after first dose of study treatment
Duration of Response
Time interval between the date of the earliest qualifying response (CR or PR) and the date of disease progression or death for any cause, whichever occurs earlier
Measured: 4 years
Average change in tumour size
Measured: 4 years
Plasma concentrations of RP-6306
Measured: Cmax, time to Tmax
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start20 Mar 2024
- Primary completion31 Oct 2025
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Lheureux, MD, Principal investigator, The Princess Margaret Cancer Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107868
- Sponsor's protocol ID
- OZUHN-019
- Other IDs
- CAPCR 23-5475
- Acronym
- GyneRep
- Status last verified
- Jun 2026
- First submitted
- 25 Oct 2023
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of the PKMYT1 Inhibitor RP-6306 in Combination With Carboplatin and Paclitaxel for the Treatment of Recurrent TP53 Ovarian and Uterine Cancer
- ClinicalTrials.gov ID
- NCT06107868
- Acronym / sponsor ID
- GyneRep / OZUHN-019
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1 study to evaluate investigational drug RP-6306 in combination with carboplatin and paclitaxel in patients with TP53 mutated ovarian or uterine cancer. The dose escalation part of the study will determine the maximum tolerated dose (MTD) and recommended Phase 2 Dose (RP2D) and schedule of RP-6306 in combination with carboplatin and paclitaxel and the dose expansion will further assess the safety and tolerability as well as determine the preliminary efficacy of RP-6306 in combination with carboplatin and paclitaxel.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A - Dose Escalation | Experimental | Drug: RP-6306, Drug: Carboplatin, Drug: PaclitaxelRP6306, 40 mg orally, twice a day, continuously or on Days 1 to 3, for 1 or 2 weeks, every 21-day cycle. Carboplatin, AUC 5 intravenously, on Day 1 of every 21-day cycle. Paclitaxel, 175 mg/m2 intravenously, on Day 1 of every 21-day cycle. |
| Part B - Dose Expansion | Experimental | Drug: RP-6306, Drug: Carboplatin, Drug: PaclitaxelRP6306, 40 mg orally at the best schedule determined in Part A. Carboplatin, AUC 5 intravenously, on Day 1 of every 21-day cycle. Paclitaxel, 175 mg/m2 intravenously, on Day 1 every 21-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Written informed consent
- Females ≥18 years old at the time of signature of the consent form.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 28 days prior to enrollment.
- All patients must have histologically proven, locally advanced or metastatic recurrent ovarian and uterine cancer. Patients will be eligible only if available curative therapy does not exist.
- Ovarian and uterine cancer should be high-grade and TP53 abnormal by immunohistochemistry or TP53 mutated by genomic profiling.
Key exclusion criteria (23 listed)
- 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 (such as transfusion-dependent anemia or thrombocytopenia), 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, carboplatin and paclitaxel. Patients are eligible if pre-medications with steroids previously controlled sensitivity and patient was able to receive treatment.
- Patients who are unable to swallow oral medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RP-6306RP-6306 is a selective inhibitor of PKMYT1 kinase. RP-6306 is an investigational agent. | Drug | Part A - Dose Escalation, Part B - Dose Expansion |
| CarboplatinCarboplatin is an antineoplastic agent. | Drug | Part A - Dose Escalation, Part B - Dose Expansion |
| PaclitaxelPaclitaxel is an antineoplastic agent. | Drug | Part A - Dose Escalation, Part B - Dose Expansion |
Primary outcome
Frequency of dose-limiting toxicities (DLTs) at Dose Level 1
Time frame: 21 days
Frequency of dose-limiting toxicities (DLTs) at Dose Level 2
Time frame: 21 days
Frequency of dose-limiting toxicities (DLTs) at Dose Level -1
Time frame: 21 days
Frequency of dose-limiting toxicities (DLTs) at Dose Level -2
Time frame: 21 days
7 secondary outcomes
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: 4 years
Progression-free survival
Time frame: 6 months
Objective response rate
Time frame: 4 years
Disease Control Rate
Time frame: At least 4 months after first dose of study treatment
Duration of Response
Time frame: 4 years
Average change in tumour size
Time frame: 4 years
Plasma concentrations of RP-6306
Time frame: Cmax, time to Tmax
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Lheureux, MD principal investigator
The Princess Margaret Cancer Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RP-6306, Carboplatin and Paclitaxel in people with Recurrent Ovarian Cancer and Recurrent Uterine Cancer, run by University Health Network, Toronto at 1 site 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 15 inclusion and 23 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: under way, not looking for participants, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Frequency of dose-limiting toxicities (DLTs) at Dose Level 1 (time frame: 21 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2026.