Study of Tuvusertib (M1774) in Combination With DNA Damage Response Inhibitor or Immune Checkpoint Inhibitor (DDRiver Solid Tumors 320)

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

June 7, 2022

Primary Completion Date

April 3, 2026

Study Completion Date

April 3, 2026

Conditions
Metastatic or Locally Advanced Unresectable Solid Tumors
Interventions
DRUG

Tuvusertib

Tuvusertib will be administered orally once daily over a defined period of time in Part A1, A1.1, A1.2, A2, A3, A2/A3, and Part B1 until disease progression, death, discontinuation, or end of study.

DRUG

Lartesertib

Lartesertib will be administered orally once daily over a defined period of time in Part A1, A1.1, A1.2, A2, A3, A2/A3, until disease progression, death, discontinuation, or end of study.

DRUG

Avelumab

Avelumab will be administered by intravenous infusion once a day over a defined period of time in Part B1 until disease progression, death, discontinuation, or end of study.

Trial Locations (22)

13620

Seoul National University Bundang Hospital, Seongnam-si

28050

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

28223

Hospital Universitario Quironsalud Madrid - NEXT Oncology, Madrid

29572

Carolina Urologic Research Center, Myrtle Beach

30912

Augusta University - formerly Georgia Regents University, Augusta

33136

University of Miami School of Medicine, Miami

66205

The University of Kansas Medical Center Research Institute, Inc., Kansas City

75230

Mary Crowley Cancer Research Centers, Dallas

77030

University of Texas M. D. Anderson Cancer Center - Partner, Houston

78229

NEXT Oncology, San Antonio

95403

Providence Medical Foundation, Santa Rosa

Unknown

Royal North Shore Hospital, St Leonards

Calvary Mater Newcastle - PARENT, Waratah

Hospital Clinic de Barcelona - Servicio de Oncologia, Barcelona

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

M5G 2C1

Princess Margaret Cancer Centre, Toronto

03722

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

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

06591

The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul

08308

Korea University Guro Hospital, Seoul

08023

Hospital QuironSalud Barcelona - Next Oncology, Barcelona

All Listed Sponsors
collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

lead

EMD Serono Research & Development Institute, Inc.

INDUSTRY

NCT05396833 - Study of Tuvusertib (M1774) in Combination With DNA Damage Response Inhibitor or Immune Checkpoint Inhibitor (DDRiver Solid Tumors 320) | Biotech Hunter | Biotech Hunter