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ACTIVE NOT RECRUITING
NCT04170153
PHASE1

Tuvusertib (M1774) in Participants With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 301)

Sponsor: EMD Serono Research & Development Institute, Inc.

View on ClinicalTrials.gov

Summary

This is an open-label, Phase I, first-in-human (FIH) multicenter, clinical study conducted in multiple parts to establish the safety, tolerability and pharmacokinetic/pharmacodynamic (PK/PD) profile (with and without food) and early signs of efficacy of Tuvuseritib (M1774) as monotherapy and in combination with the poly (ADP-ribose) polymerase (PARP) inhibitor niraparib.

Official title: An Open-label, Multicenter Trial of the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of Tuvusertib (M1774) in Participants With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 301)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

161

Start Date

2019-12-20

Completion Date

2027-01-30

Last Updated

2026-01-30

Healthy Volunteers

No

Interventions

DRUG

M1774

M1774 will be administered orally throughout the study.

DRUG

Niraparib

Niraparib will be administered orally throughout the study.

Locations (16)

Massachusetts General Hospital

Boston, Massachusetts, United States

NEXT Oncology

Austin, Texas, United States

Mary Crowley Cancer Research Centers

Dallas, Texas, United States

The Methodist Hospital Research Institute

Houston, Texas, United States

University of Texas M. D. Anderson Cancer Center - Investigational Cancer Therapeutics

Houston, Texas, United States

Beijing Cancer Hospital

Beijing, China

National Cancer Center Hospital - Dept of Experimental Therapeutics

Chūōku, Japan

National Cancer Center Hospital East - Dept of Experimental Therapeutics

Kashiwa-shi, Japan

Hospital Clinic de Barcelona - Servicio de Oncologia

Barcelona, Spain

Hospital Universitari Vall d'Hebron - Oncology Dept.

Barcelona, Spain

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

Madrid, Spain

Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica

Valencia, Spain

Addenbrooke's Hospital - Dept of Oncology

Cambridge, United Kingdom

The Christie Hospital - Dept of Oncology

Manchester, United Kingdom

Northern Centre for Cancer Care - Sir Bobby Robson Cancer Trials Research Centre

Newcastle upon Tyne, United Kingdom

Royal Marsden Hospital - Dept of Oncology

Sutton, United Kingdom