NCT06421935

M9466 Alone or in Combination in Advanced Solid Tumors (DDriver 501)

An Open Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of the PARP1 Inhibitor M9466 Alone or in Combination in Participants With Advanced Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 141 (estimated)
• Sponsor: EMD Serono Research & Development Institute, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic profile of M9466 with and without tuvusertib or an ARPi and early signs of clinical activity of M9466 with tuvusertib in participants with advanced solid tumors. Study details include: Study/Treatment Duration: Participants will be treated until disease progression, death, discontinuation, or End of Study. Visit Frequency: Every week in the first 2 cycles, followed by every 3 weeks in the subsequent cycles. An End of Treatment Visit and Safety Follow-up/Discontinuation Visit are scheduled after the treatment period.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	M9466	Participants will be administered M9466 orally.
DRUG	Tuvusertib	Participants will be administered Tuvusertib orally.
DRUG	Abiraterone acetate	Participants will be administered with Abiraterone acetate orally.
DRUG	Prednisone/Prednisolone	Participants will be administered with prednisone/prednisolone orally.

Timeline

• Start date: 2024-08-07
• Primary completion: 2027-02-22
• Completion: 2027-02-22
• First posted: 2024-05-20
• Last updated: 2026-03-24

Locations

20 sites across 5 countries: United States, Australia, Japan, South Korea, Spain

Regulatory

• FDA-regulated drug study