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M1774

DRUG6 trials

Sponsors

Merck Healthcare KGaA, Grupo Espanol De Investigacion En Neurooncologia, EMD Serono Research & Development Institute, Inc., Institut Paoli-Calmettes, Panagiotis Konstantinopoulos, MD, PhD

Conditions

ARID1A Gene MutationATRX-mutated and p53-mutated astrocytomaBreast CancerEndometrial CancerIDH1/2-mutatedMetastatic or Locally Advanced Unresectable Solid TumorsNon-Small Cell Lung CancerNon-Squamous Non-Small Cell Lung Cancer

Phase 1

Tuvusertib (M1774) in Participants With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 301)
Active, not recruitingNCT04170153
EMD Serono Research & Development Institute, Inc.Metastatic or Locally Advanced Unresectable Solid Tumors
Start: 2019-12-20End: 2027-01-30Updated: 2026-01-30
Tuvusertib (M1774) in Combination With Cemiplimab in Participants With Non-Squamous NSCLC (DDRiver NSCLC 322)
Active, not recruitingNCT05882734
EMD Serono Research & Development Institute, Inc.Non-Small Cell Lung Cancer
Start: 2023-09-13End: 2026-03-30Updated: 2026-02-17
I/II Phase Study Evaluating M1774 in Combination With Fulvestrant in HR+ and HER2- Advanced Breast Cancers
Not yet recruitingNCT05986071
Institut Paoli-CalmettesBreast Cancer
Start: 2024-05-01End: 2027-10-15Target: 57Updated: 2024-03-29
An open-label, multicenter, Phase 1b/2a study to evaluate efficacy, safety, tolerability, and pharmacokinetics of the ATR inhibitor Tuvusertib (M1774) in combination with cemiplimab in participants with non-squamous non-small cell lung cancer that has progressed on prior anti-PD-(L)1 and platinum-based therapies (DDRiver NSCLC 322)
Active, not recruitingCTIS2022-502010-85-00
Merck Healthcare KGaANon-Squamous Non-Small Cell Lung Cancer
Start: 2023-12-20Target: 170Updated: 2026-01-26

Phase 2

Avelumab and M1774 in ARID1A-mutated Endometrial Cancer
RecruitingNCT06518564
Panagiotis Konstantinopoulos, MD, PhDARID1A Gene Mutation, Endometrial Cancer, Recurrent Endometrial Carcinoma
Start: 2024-11-14End: 2029-08-31Target: 25Updated: 2026-01-07
Efficacy of Tuvusertib in Recurrent IDH mutant Astrocytoma with ATRX mutation, a phase II prospective trial.
RecruitingCTIS2025-521843-19-00
Grupo Espanol De Investigacion En NeurooncologiaATRX-mutated and p53-mutated astrocytoma, IDH1/2-mutated
Start: 2025-12-19Target: 56Updated: 2025-11-11

Related Papers

Integrated Population Pharmacokinetic, Pharmacodynamic, and Safety Analyses to Inform Dosage Selection in the Clinical Development of the <scp>ATR</scp> Inhibitor Tuvusertib
Clinical Pharmacology & Therapeutics2025-08-21
JS02.6.A PRELIMINARY SIGNS OF CLINICAL ACTIVITY OF TUVUSERTIB (M1774), A HIGHLY POTENT ORAL ATR INHIBITOR, IN REFRACTORY IDH MUTATED GLIOMA PATIENTS WITH P53 AND ATRX MUTATIONS; A CASE SERIES FROM A FIH STUDY
Neuro-Oncology2024-10-01
A phase I study of highly potent oral ATR inhibitor (ATRi) tuvusertib plus oral PARP inhibitor (PARPi) niraparib in patients with solid tumors.
Journal of Clinical Oncology2024-06-014 citations
104TiP Phase Ib/IIa study of ATR inhibitor tuvusertib + anti-PD-1 cemiplimab in patients with advanced non-squamous (nsq) non-small cell lung cancer (NSCLC) that has progressed on prior anti-PD-(L)1 and platinum-based therapies
ESMO Open2024-03-011 citations
First-in-Human Study of the Ataxia Telangiectasia and Rad3-Related (ATR) Inhibitor Tuvusertib (M1774) as Monotherapy in Patients with Solid Tumors
Clinical Cancer Research2024-02-2634 citations
A phase I study of ATR inhibitor gartisertib (M4344) as a single agent and in combination with carboplatin in patients with advanced solid tumours
British Journal of Cancer2024-01-2924 citations
Abstract C162: Assessment of the potential for QTc prolongation by the investigational ATR inhibitor tuvusertib in patients with advanced solid tumors using integrated nonclinical and clinical assessments
Molecular Cancer Therapeutics2023-12-01
Abstract CT271: Translational analyses of ATR inhibitor M1774 in a Phase I study in patients with solid tumors (DDRiver Solid Tumors 301)
Cancer Research2023-04-143 citations
Abstract CT272: Pharmacodynamic and immunophenotyping analyses of ATR inhibitor M1774 in a Phase I study in patients with solid tumors (DDRiver Solid Tumors 301)
Cancer Research2023-04-142 citations
Abstract 2588: M1774, a novel potent and selective ATR inhibitor, shows antitumor effects as monotherapy and in combination
Cancer Research2022-06-158 citations
A first-in-human phase I study of ATR inhibitor M1774 in patients with solid tumors.
Journal of Clinical Oncology2021-05-2021 citations