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ACTIVE NOT RECRUITING
NCT06421935
PHASE1

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

Sponsor: EMD Serono Research & Development Institute, Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

141

Start Date

2024-08-07

Completion Date

2027-02-22

Last Updated

2026-03-24

Healthy Volunteers

No

Interventions

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.

Locations (20)

NEXT Oncology - PARENT

New York, New York, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Cancer Research SA

Adelaide, Australia

GenesisCare North Shore (Oncology)

St Leonards, Australia

Harasanshin Hospital

Fukuoka, Japan

National Cancer Center Hospital East - Dept of Experimental Therapeutics

Kashiwa-shi, Japan

Cancer Institute Hospital of JFCR

Kōtoku, Japan

NHO Kumamoto Medical Center - Dept of Urology

Kumamoto, Japan

Seoul National University Bundang Hospital

Seongnam, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System - Division of Infectious Diseases

Seoul, South Korea

Hospital HM Nou Delfos - START Barcelona

Barcelona, Spain

Hospital Universitari Vall d'Hebron - Oncology Dept.

Barcelona, Spain

ICO l'Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia

Barcelona, Spain

Centro Integral Oncologico Clara Campal - Unidad de Fase I-Oncologica

Madrid, Spain

Hospital Universitario 12 de Octubre - Servicio de Oncologia

Madrid, Spain

Hospital Universitario Fundacion Jimenez Diaz - START Madrid FJD - Oncology Phase I

Madrid, Spain

NEXT Madrid - Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Spain