NCT06107868

Phase 1 Study of RP-6306 With Carboplatin and Paclitaxel in TP53 Ovarian and Uterine Cancer

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	RP-6306	RP-6306 is a selective inhibitor of PKMYT1 kinase. RP-6306 is an investigational agent.
DRUG	Carboplatin	Carboplatin is an antineoplastic agent.
DRUG	Paclitaxel	Paclitaxel is an antineoplastic agent.

Timeline

• Start date: 2024-03-20
• Primary completion: 2025-10-31
• Completion: 2026-01-30
• First posted: 2023-10-30
• Last updated: 2025-12-08

Locations

1 site across 1 country: Canada