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drugset / Trial / NCT06719973

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

NCT06719973 ↗

Phase 1 Withdrawn EMD Serono Research & Development Institute, Inc. Merck KGaA, Darmstadt, Germany · collab
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2025-05-14
Primary completion
2025-05-14
Completion
2025-05-14

Outcome

Outcome not reported

Stopped (Business): “Study was terminated due to decision made not to proceed with the clinical trial DDRiver 521, that has not yet commenced enrolment, for strategic reasons.”

Drugs

EvaluationDrugModalityDoseRoute
Subject M9466 Unknown — Oral
Background Atezolizumab Monoclonal antibody — Intravenous
Background Carboplatin Small molecule — Intravenous
Background Etoposide Small molecule — Intravenous

Indications

cancer