NCT05147350

Study of RP-6306 With FOLFIRI in Advanced Solid Tumors

Phase 1 Study of the PKMYT1 Inhibitor RP-6306 in Combination With FOLFIRI for the Treatment of Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Debiopharm International SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to assess the safety and tolerability of RP-6306 with FOLFIRI in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD), identify a recommended phase 2 dose (RP2D) and preferred schedule, and assess preliminary anti-tumor activity.

Detailed description

To assess the safety and tolerability of RP-6306 in combination with FOLFIRI in patients with eligible, advanced solid tumors. Incidence and severity of treatment-emergent adverse events (TEAEs), laboratory assessments, vital signs, electrocardiograms (ECGs), and use of concomitant medications. The Sponsor of the study has changed from 'Repare Therapeutics' to 'Debiopharm International SA' in the United States.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	RP-6306 (oral PKMYT1 inhibitor)	RP-6306 (Oral) in combination with FOLFIRI (IV)

Timeline

• Start date: 2022-08-09
• Primary completion: 2025-02-12
• Completion: 2025-02-12
• First posted: 2021-12-07
• Last updated: 2025-12-05
• Results posted: 2025-08-20

Locations

9 sites across 4 countries: United States, Canada, Spain, United Kingdom

Regulatory

• FDA-regulated drug study