Tuvusertib

Generic Name: Tuvusertib

Clinical Trials

Avelumab and M1774 in ARID1A-mutated Endometrial Cancer (Prior IO)

Phase 2

Recruiting

Conditions: Endometrial Cancer
ARID1A Gene Mutation
Recurrent Endometrial Carcinoma

Interventions: Drug: Avelumab
Drug: M1774

First Posted Date: 2024-07-24

Last Posted Date: 2024-11-27

Lead Sponsor: Panagiotis Konstantinopoulos, MD, PhD

Target Recruit Count: 25

Registration Number: NCT06518564

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States

Study of Avelumab and Tuvusertib in Participants With Advanced Urothelial Cancer That Has Progressed on Prior Anti-PD-(L)1 Therapy (JAVELIN DDRiver Bladder)

Phase 2

Not yet recruiting

Conditions: Urothelial Carcinoma

Interventions: Drug: Avelumab
Drug: Tuvusertib

First Posted Date: 2024-05-22

Last Posted Date: 2024-07-31

Lead Sponsor: EMD Serono Research & Development Institute, Inc.

Target Recruit Count: 70

Registration Number: NCT06424717

Locations: 🇩🇪
Please Contact the Communication Center, Darmstadt, Germany
🇺🇸
Please Contact U.S. Medical Information, Rockland, Massachusetts, United States

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

Phase 1

Recruiting

Conditions: Advanced Solid Tumor

Interventions: Drug: M9466
Drug: Abiraterone acetate
Drug: Prednisone/Prednisolone
Drug: Tuvusertib

First Posted Date: 2024-05-20

Last Posted Date: 2025-05-13

Lead Sponsor: EMD Serono Research & Development Institute, Inc.

Target Recruit Count: 96

Registration Number: NCT06421935

Locations: 🇰🇷
Seoul National University Bundang Hospital, Seongnam, Korea, Republic of
🇰🇷
Samsung Medical Center, Seoul, Korea, Republic of
🇰🇷
Seoul National University Hospital, Seoul, Korea, Republic of

and more 15 locations

Tuvusertib (M1774) Human Mass Balance and Absolute Bioavailability Study (DDRIVER Solid Tumors 303)

Phase 1

Recruiting

Conditions: Solid Tumor

Interventions: Drug: Tuvusertib [14C]Tuvusertib microtracer
Drug: Tuvusertib
Drug: Tuvusertib + [14C]Tuvusertib microdose bolus injection

First Posted Date: 2024-03-13

Last Posted Date: 2025-05-11

Lead Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Target Recruit Count: 12

Registration Number: NCT06308263

Locations: 🇭🇺
Pharmaceutical Research Associates Magyarország Kutatás - Fejlesztési Kft., Klinikai Farmakológiai Vizsgálóhely, Budapest, Hungary
🇭🇺
Észak Pesti Centrum Kórház-Honvédkórház, Onkológiai Osztály, Budapest, Hungary

I/II Phase Study Evaluating M1774 in Combination With Fulvestrant in HR+ and HER2- Advanced Breast Cancers

Phase 1

Not yet recruiting

Conditions: Breast Cancer

Interventions: Drug: M1774
Drug: Fulvestrant injection

First Posted Date: 2023-08-14

Last Posted Date: 2024-03-29

Lead Sponsor: Institut Paoli-Calmettes

Target Recruit Count: 57

Registration Number: NCT05986071

Locations: 🇫🇷
Institut Paoli Calmettes, Marseille, France

Testing Different Amounts of the Combination of Drugs M1774 and ZEN-3694 for the Treatment of Recurrent Ovarian and Endometrial Cancer

Phase 1

Recruiting

Conditions: Ovarian High Grade Serous Adenocarcinoma
Endometrial Carcinoma
Platinum-Resistant Ovarian Carcinoma
Endometrial Clear Cell Adenocarcinoma
Endometrial Endometrioid Adenocarcinoma
Ovarian Clear Cell Adenocarcinoma
Ovarian Endometrioid Adenocarcinoma
Endometrial Low Grade Endometrioid Adenocarcinoma
Ovarian Low Grade Endometrioid Adenocarcinoma

Interventions: Drug: BET Bromodomain Inhibitor ZEN-3694
Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Electrocardiography
Procedure: Magnetic Resonance Imaging
Drug: Tuvusertib
Procedure: X-Ray Imaging

First Posted Date: 2023-07-18

Last Posted Date: 2025-05-15

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 60

Registration Number: NCT05950464

Locations: 🇺🇸
Augusta University Medical Center, Augusta, Georgia, United States
🇺🇸
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
🇺🇸
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States

and more 11 locations

Testing the Combination of Two Anticancer Drugs M1774 (Tuvusertib) and Avelumab to Evaluate Their Safety and Effectiveness in Treating Merkel Cell Skin Cancer, MATRiX Trial

Phase 2

Suspended

Conditions: Unresectable Merkel Cell Carcinoma
Locally Advanced Merkel Cell Carcinoma
Metastatic Merkel Cell Carcinoma
Refractory Merkel Cell Carcinoma
Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8
Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8

Interventions: Procedure: Biopsy Procedure
Drug: Avelumab
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Procedure: Positron Emission Tomography
Drug: Tuvusertib

First Posted Date: 2023-07-17

Last Posted Date: 2025-05-20

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 50

Registration Number: NCT05947500

Locations: 🇺🇸
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care, Irvine, California, United States
🇺🇸
Keck Medicine of USC Koreatown, Los Angeles, California, United States
🇺🇸
UC San Diego Moores Cancer Center, La Jolla, California, United States

and more 47 locations

Tuvusertib (M1774) in Combination With Cemiplimab in Participants With Non-Squamous NSCLC (DDRiver NSCLC 322)

Phase 1

Active, not recruiting

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: M1774
Drug: Cemiplimab

First Posted Date: 2023-05-31

Last Posted Date: 2025-01-27

Lead Sponsor: EMD Serono Research & Development Institute, Inc.

Target Recruit Count: 180

Registration Number: NCT05882734

Locations: 🇧🇪
CHU de Liège - PARENT, Liege, Belgium
🇺🇸
UPMC Cancer Center, Pittsburgh, Pennsylvania, United States
🇺🇸
UCLA Hematology and Oncology - Santa Monica, Santa Monica, California, United States

and more 51 locations

Testing the Effect of M1774 on Hard-to-Treat Refractory SPOP-mutant Prostate Cancer

Phase 2

Suspended

Conditions: Castration-Resistant Prostate Carcinoma
Metastatic Castration-Resistant Prostate Carcinoma
Stage IVB Prostate Cancer AJCC v8
Refractory Prostate Carcinoma

Interventions: Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Procedure: Positron Emission Tomography
Drug: Tuvusertib
Procedure: Ultrasound Imaging

First Posted Date: 2023-04-25

Last Posted Date: 2025-05-04

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 20

Registration Number: NCT05828082

Locations: 🇺🇸
Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States
🇺🇸
UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States
🇺🇸
UM Sylvester Comprehensive Cancer Center at Aventura, Aventura, Florida, United States

and more 23 locations

Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety and Effectiveness

Phase 1

Recruiting

Conditions: Metastatic Malignant Solid Neoplasm
Advanced Malignant Solid Neoplasm
Metastatic Microsatellite Stable Colorectal Carcinoma
Stage IV Colorectal Cancer AJCC v8
Hematopoietic and Lymphatic System Neoplasm
Advanced Microsatellite Stable Colorectal Carcinoma
Stage III Colorectal Cancer AJCC v8

Interventions: Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Drug: Temozolomide
Drug: Tuvusertib

First Posted Date: 2023-01-20

Last Posted Date: 2025-04-09

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 58

Registration Number: NCT05691491

Locations: 🇺🇸
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
🇺🇸
Yale University, New Haven, Connecticut, United States
🇺🇸
Smilow Cancer Hospital Care Center-Trumbull, Trumbull, Connecticut, United States

and more 16 locations

Drug Development Updates

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