Phase 1 Study of RP-6306 With Carboplatin and Paclitaxel in TP53 Ovarian and Uterine Cancer
NCT06107868 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2025-12-08
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 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.
Conditions
- Recurrent Ovarian Cancer
- Recurrent Uterine Cancer
- Metastatic Cancer
- Advanced Cancer
Interventions
- DRUG
-
RP-6306
RP-6306 is a selective inhibitor of PKMYT1 kinase. RP-6306 is an investigational agent.
- DRUG
-
Carboplatin is an antineoplastic agent.
- DRUG
-
Paclitaxel is an antineoplastic agent.
Sponsors & Collaborators
-
University Health Network, Toronto
lead OTHER
Principal Investigators
-
Stephanie Lheureux, MD · The Princess Margaret Cancer Foundation
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-03-20
- Primary Completion
- 2025-10-31
- Completion
- 2026-01-30
Countries
- Canada
Study Locations
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