Tuvusertib

DRUG10 trials

Sponsors

EMD Serono Research & Development Institute, Inc., National Cancer Institute (NCI), Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, Grupo Español de Investigación en Neurooncología

Conditions

Advanced Malignant Solid NeoplasmAdvanced Microsatellite Stable Colorectal CarcinomaAdvanced Solid TumorAstrocytomaCastration-Resistant Prostate CarcinomaClinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8Hematopoietic and Lymphatic System Neoplasm

Phase 1

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

Active, not recruitingNCT05396833

EMD Serono Research & Development Institute, Inc.Metastatic or Locally Advanced Unresectable Solid Tumors

Start: 2022-06-07End: 2026-04-10Updated: 2026-02-19

Testing the Combination of Two Anti-cancer Drugs, Peposertib (M3814) and Tuvusertib (M1774) for Advanced Solid Tumors

RecruitingNCT05687136

National Cancer Institute (NCI)Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm

Start: 2024-06-07End: 2026-08-31Target: 66Updated: 2026-04-03

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

RecruitingNCT05691491

National Cancer Institute (NCI)Advanced Malignant Solid Neoplasm, Advanced Microsatellite Stable Colorectal Carcinoma, Hematopoietic and Lymphatic System Neoplasm +4

Start: 2023-09-28End: 2027-03-01Target: 58Updated: 2026-04-03

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

RecruitingNCT05950464

National Cancer Institute (NCI)Recurrent Endometrial Carcinoma, Recurrent Endometrial Clear Cell Adenocarcinoma, Recurrent Endometrial Endometrioid Adenocarcinoma +6

Start: 2023-12-18End: 2026-04-30Target: 60Updated: 2026-04-03

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

Active, not recruitingNCT06308263

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanySolid Tumor

Start: 2024-03-25End: 2026-03-23Updated: 2026-01-30

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

Active, not recruitingNCT06421935

EMD Serono Research & Development Institute, Inc.Advanced Solid Tumor

Start: 2024-08-07End: 2027-02-22Target: 141Updated: 2026-03-24

Phase 2

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

Active, not recruitingNCT05828082

National Cancer Institute (NCI)Castration-Resistant Prostate Carcinoma, Metastatic Castration-Resistant Prostate Carcinoma, Refractory Prostate Carcinoma +1

Start: 2023-10-16End: 2026-06-18Target: 20Updated: 2026-03-23

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

Active, not recruitingNCT05947500

National Cancer Institute (NCI)Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8, Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8, Locally Advanced Merkel Cell Carcinoma +3

Start: 2024-05-21End: 2028-01-01Target: 50Updated: 2026-04-03

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

WithdrawnNCT06424717

EMD Serono Research & Development Institute, Inc.Urothelial Carcinoma

Start: 2024-08-16End: 2026-01-27Updated: 2024-09-27

Tuvusertib in Astrocytoma With ATRX Mutation

RecruitingNCT07417761

Grupo Español de Investigación en NeurooncologíaAstrocytoma

Start: 2025-12-19End: 2028-09-01Target: 56Updated: 2026-04-02

Related Papers

The MATRiX trial: A multicenter, randomized, phase II study of ATR inhibition (via tuvusertib) with or without avelumab in patients with advanced anti-PD-(L)1–refractory Merkel cell carcinoma.

Journal of Clinical Oncology2025-05-281 citations

Abstract 1171: M9466 (HRS-1167): A highly potent and selective PARP1 inhibitor with DNA trapping activity, monotherapy antitumor activity and synergistic potential with DDR inhibitors and chemotherapies

Cancer Research2025-04-21

Pharmacokinetic (PK) and pharmacodynamic (PD) findings from a phase 1b study of ATR inhibitor tuvusertib + anti-PD-L1 avelumab in patients with advanced unresectable solid tumors.

Journal of Clinical Oncology2024-06-012 citations

Pharmacodynamic (PD) and immunophenotyping analyses of ATR inhibitor (ATRi) tuvusertib + ATM inhibitor (ATMi) lartesertib in a phase Ib study in patients with advanced unresectable solid tumors.

Journal of Clinical Oncology2024-06-01

Abstract CT063: Phase Ib trial of ATR inhibitor (ATRi) tuvusertib + ATM inhibitor (ATMi) lartesertib (M4076) in patients (pts) with advanced solid tumors

Cancer Research2024-04-055 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