New drug cocktail targets Hard-to-Treat ovarian and uterine cancers
NCT ID NCT06107868
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This early-phase trial tests an investigational drug called RP-6306 alongside standard chemotherapy (carboplatin and paclitaxel) in 6 women with recurrent ovarian or uterine cancer that has a specific genetic change (TP53 mutation). The main goal is to find a safe dose and check for side effects. It is a first step to see if this combination might help when other treatments have stopped working.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RP-6306 (a PKMYT1 inhibitor) combined with carboplatin and paclitaxel chemotherapy
- What this could lead to
- If successful, this could lead to a new treatment option for people with recurrent ovarian or uterine cancer that has not responded to standard therapies.
- What could go wrong
- This is a very early, small Phase 1 trial with only 6 participants, focused on safety and dosing. It is too soon to know if the combination will work or be safe for broader use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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6 people
The number who actually took part.
- Started
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Mar 2024
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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. * 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: 1. Unstable angina pectoris 2. Congestive heart failure 3. Acute myocardial infarction 4. Conduction abnormality not controlled with pacemaker or medication 5. Significant ventricular or supraventricular arrhythmias (patients with chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible) 6. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
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