NCT06719973

Phase 1 Study of M9466 Combined With Carboplatin and Platinum-based Anticancer Therapy (DDRiver 521)

An Open Label, Multicenter, Phase 1 Study of the PARP1 Inhibitor M9466 in Combination With Carboplatin and Platinum-based Anticancer Therapy (DDRiver 521)

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (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, tolerability, pharmacokinetics, pharmacodynamic, and preliminary clinical activity of M9466 in combinations with carboplatin in advanced or metastatic refractory solid tumor and with the standard of care (carboplatin, etoposide, and atezolizumab) in treatment-naïve ES-SCLC. The results will support any investigation of carboplatin-based combination anticancer treatments with M9466 as well as the selection of a RP2D of M9466 in combination with carboplatin, etoposide, and atezolizumab for a subsequent ES-SCLC study.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	M9466	Participants will receive an escalating doses of M9466 orally in 21-day cycles until disease progression, intolerable toxicity, death, withdrawal of study or study consent, lost to follow-up, or end of study.
DRUG	Carboplatin	Carboplatin will be administered intravenously on Day 1 of each 21-day cycle.
DRUG	Etoposide	Etoposide will be administered intravenously as per standard of care.
DRUG	Atezolizumab	Atezolizumab will be administered intravenously as per standard of care.
DRUG	M9446	M9446 dose will be further investigated in Module 2 Part A of the study.
DRUG	M9446	M9446 recommended Dose for Expansion (RDE) will be further investigated in Module 2 Part B of the study.
DRUG	Carboplatin	Carboplatin will be administered intravenously as per standard of care.

Timeline

• Start date: 2025-05-14
• Primary completion: 2025-05-14
• Completion: 2025-05-14
• First posted: 2024-12-06
• Last updated: 2025-06-17

Regulatory

• FDA-regulated drug study