NCT06509906

M9466 in Combination With Topoisomerase 1 Inhibitors-based Regimens in Advanced Solid Tumors and Colorectal Cancer (DDRiver 511)

An Open Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of the PARP1 Inhibitor M9466 in Combination With Topoisomerase 1 Inhibitor-based Regimens in Advanced Solid Tumors and Colorectal Cancer (DDRiver 511)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• 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 and preliminary clinical activity of M9466 in combination with topoisomerase 1 inhibitors-based regimens. As such the combination with FOLFIRI (folinic acid, fluorouracil, irinotecan) and Bevacizumab will be evaluated in participants with colorectal cancer, to establish the M9466 maximum tolerated dose if observed and the recommended dose for expansion. Study Duration: After a Screening period of up to 28 days, enrolled participants will remain in the study until they have completed all the study visits or until they withdraw consent, are lost to follow-up, or die. Visit Frequency: The participants will come for a Screening Visit and 1 to 2 visits per treatment cycle. After end of study intervention period, the participants will come for an End of Treatment Visit and a Safety Follow-up Visit.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	M9466	M9466 will be administered orally until progressive disease, unacceptable toxicity, death, or end of study.
DRUG	Irinotecan	Irinotecan will be administered intravenously once every 2 weeks (q2w) until progressive disease, unacceptable toxicity, death, or end of study.
DRUG	Folinic acid	Folinic acid will be administered intravenously q2w as per standard of care.
DRUG	Fluorouracil (5-FU)	Fluorouracil will be administered intravenously as per standard of care.
DRUG	Bevacizumab	Bevacizumab will be administered intravenously, q2w until progressive disease, unacceptable toxicity, death, or end of study.
DRUG	Granulocyte colony stimulating factor (G-CSF)	G-CSF will be administered subcutaneously at every cycle of study intervention as per standard of care.

Timeline

• Start date: 2024-10-08
• Primary completion: 2025-12-02
• Completion: 2025-12-02
• First posted: 2024-07-19
• Last updated: 2025-12-18

Locations

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

Regulatory

• FDA-regulated drug study