NCT04855656

Study of Lunresertib Alone or in Combination With RP-3500 or Debio 0123 in Patients With Advanced Solid Tumors

Phase 1/1b Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of Lunresertib Alone or in Combination With RP-3500 or Debio 0123 in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 464 (estimated)
• Sponsor: Debiopharm International SA · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to assess the safety and tolerability of lunresertib alone and in combination with RP-3500 or in combination with Debio 0123 in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) and assess preliminary anti-tumor activity.

Detailed description

Phase 1/1b, multi-center, open-label, dose-escalation study to: * Evaluate the safety profile and MTD of lunresertib alone and in combination with RP-3500 or in combination with Debio 0123 when administered orally to establish the recommended Phase 2 dose and schedule * Characterize the PK and pharmacodynamics of lunresertib alone and in combination with RP-3500 or in combination with Debio 0123 * Assess preliminary anti-tumor activity associated with lunresertib alone and in combination with RP-3500 or in combination with Debio 0123 This study was previously posted by Repare Therapeutics. In September 2025, sponsorship of the trial was transferred to Debiopharm International S.A Expanded Access Status: There is no expanded access program available for the investigational products in this study at this time.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	Lunresertib	Oral PKMYT1 Inhibitor
DRUG	RP-3500	Oral ATR Inhibitor
DRUG	Debio0123	Oral WEE1 Inhibitor

Timeline

• Start date: 2021-04-30
• Primary completion: 2027-12-01
• Completion: 2028-06-01
• First posted: 2021-04-22
• Last updated: 2026-04-20

Locations

22 sites across 4 countries: United States, Canada, Denmark, United Kingdom

Regulatory

• FDA-regulated drug study