Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
This trial is for women over 18 with advanced or recurrent ovarian and uterine cancer that's TP53 mutated, who can take oral meds, have good organ function, are not pregnant, and agree to use contraception. Excluded are those with recent major surgery, life-threatening conditions, uncontrolled infections like HIV/Hepatitis B/C, severe liver impairment or heart disease.Inclusion Criteria
My ovarian or uterine cancer is advanced, cannot be cured with existing treatments.
I have tissue samples available for genetic testing.
My organs are functioning well enough for the study.
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Exclusion Criteria
I haven't had chemotherapy or targeted cancer drugs within the last 3 weeks.
I don't have any health issues that could affect the study's results or my participation.
I am not allergic to RP-6306, carboplatin, or paclitaxel, or I can take them with steroids.
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Participant Groups
The study tests RP-6306 combined with carboplatin and paclitaxel in patients. It aims to find the safest dose (MTD) and see how well it works (efficacy). The first part sets the dose; the second part expands on safety data and preliminary effectiveness.
2Treatment groups
Experimental Treatment
Group I: Part B - Dose ExpansionExperimental Treatment3 Interventions
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.
Group II: Part A - Dose EscalationExperimental Treatment3 Interventions
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.
Carboplatin is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Paraplatin for:
- Ovarian cancer
- Testicular cancer
- Lung cancer
- Head and neck cancer
- Brain cancer
🇪🇺 Approved in European Union as Carboplatin for:
- Ovarian cancer
- Small cell lung cancer
🇨🇦 Approved in Canada as Carboplatin for:
- Ovarian cancer
- Small cell lung cancer
- Testicular cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Princess Margaret Cancer CentreToronto, Canada
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Who Is Running the Clinical Trial?
University Health Network, TorontoLead Sponsor