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M9466 Alone or in Combination in Advanced Solid Tumors (DDriver 501)
Sponsor: EMD Serono Research & Development Institute, Inc.
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
Conditions
Interventions
M9466
Participants will be administered M9466 orally.
Tuvusertib
Participants will be administered Tuvusertib orally.
Abiraterone acetate
Participants will be administered with Abiraterone acetate orally.
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