NCT05147272

Study of RP-6306 With Gemcitabine in Advanced Solid Tumors

Phase 1 Study of the PKMYT1 Inhibitor RP-6306 in Combination With Gemcitabine for the Treatment of Advanced Solid Tumors (MAGNETIC Study)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 67 (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 in combination gemcitabine, in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) of RP-6306 in combination with gemcitabine, identify a recommended phase 2 dose (RP2D) and preferred schedule, examine preliminary pharmacokinetics (PK) and assess anti-tumor activity.

Detailed description

Phase 1, multi-center, open-label, dose-escalation study to: * Evaluate the safety profile and MTD of RP-6306 with gemcitabine to establish the RP2D and schedule * Characterize the PK and pharmacodynamics of RP-6306 with gemcitabine * Assess preliminary anti-tumor activity associated with RP-6306 with gemcitabine The Sponsor of the study has changed from 'Repare Therapeutics' to 'Debiopharm International SA' in the United States.

Conditions

• Adult Solid Tumor

Interventions

Type	Name	Description
DRUG	RP-6306 (oral PKMYT1 inhibitor)	RP-6306 in combination with gemcitabine

Timeline

• Start date: 2021-12-16
• Primary completion: 2024-08-28
• Completion: 2024-08-28
• First posted: 2021-12-07
• Last updated: 2025-12-05
• Results posted: 2025-10-16

Locations

11 sites across 3 countries: United States, Canada, United Kingdom

Regulatory

• FDA-regulated drug study