Clinical Trials

Multiple clinical trials in Phase I and Phase II are evaluating the oral ATR kinase inhibitor tuvusertib (M1774) as monotherapy and combination therapy for advanced, metastatic, or refractory malignancies. Sponsored by pharmaceutical companies, governmental entities, and academic centers, these studies target conditions including solid tumors, prostate carcinoma, colorectal cancer, astrocytoma, Merkel cell carcinoma, and recurrent gynecologic cancers. Current protocols encompass active, recruiting, completed, terminated, and withdrawn statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07417761 RECRUITING
Astrocytoma
Grupo Español de Investigación en Neurooncología
 2025-12-19 PHASE2
NCT05947500 ACTIVE_NOT_RECRUITING
Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8; Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8; Locally Advanced Merkel Cell Carcinoma; Metastatic Merkel Cell Carcinoma; Refractory Merkel Cell Carcinoma; Unresectable Merkel Cell Carcinoma
National Cancer Institute (NCI)
 2024-05-21 PHASE2
NCT05687136 RECRUITING
Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm; Unresectable Malignant Solid Neoplasm
National Cancer Institute (NCI)
 2024-06-07 PHASE1
NCT05950464 RECRUITING
Recurrent Endometrial Carcinoma; Recurrent Endometrial Clear Cell Adenocarcinoma; Recurrent Endometrial Endometrioid Adenocarcinoma; Recurrent Endometrial Low Grade Endometrioid Adenocarcinoma; Recurrent Ovarian Clear Cell Adenocarcinoma; Recurrent Ovarian Endometrioid Adenocarcinoma; Recurrent Ovarian High Grade Serous Adenocarcinoma; Recurrent Ovarian Low Grade Endometrioid Adenocarcinoma; Recurrent Platinum-Resistant Ovarian Carcinoma
National Cancer Institute (NCI)
 2023-12-18 PHASE1
NCT05691491 RECRUITING
Advanced Malignant Solid Neoplasm; Advanced Microsatellite Stable Colorectal Carcinoma; Hematopoietic and Lymphatic System Neoplasm; Metastatic Malignant Solid Neoplasm; Metastatic Microsatellite Stable Colorectal Carcinoma; Stage III Colorectal Cancer AJCC v8; Stage IV Colorectal Cancer AJCC v8
National Cancer Institute (NCI)
 2023-09-28 PHASE1; PHASE2
NCT06421935 ACTIVE_NOT_RECRUITING
Advanced Solid Tumor
EMD Serono Research & Development Institute, Inc.
 2024-08-07 PHASE1
NCT05396833 ACTIVE_NOT_RECRUITING
Metastatic or Locally Advanced Unresectable Solid Tumors
EMD Serono Research & Development Institute, Inc.
 2022-06-07 PHASE1
NCT05828082 ACTIVE_NOT_RECRUITING
Castration-Resistant Prostate Carcinoma; Metastatic Castration-Resistant Prostate Carcinoma; Refractory Prostate Carcinoma; Stage IVB Prostate Cancer AJCC v8
National Cancer Institute (NCI)
 2023-10-16 PHASE2
NCT04170153 ACTIVE_NOT_RECRUITING
Metastatic or Locally Advanced Unresectable Solid Tumors
EMD Serono Research & Development Institute, Inc.
 2019-12-20 PHASE1
NCT06433219 ACTIVE_NOT_RECRUITING
Ovarian Cancer
EMD Serono Research & Development Institute, Inc.
 2024-10-30 PHASE2
NCT06308263 COMPLETED
Solid Tumor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
 2024-03-25 PHASE1
NCT06424717 WITHDRAWN
Urothelial Carcinoma
EMD Serono Research & Development Institute, Inc.
 2024-08-16 PHASE2
NCT06337630 TERMINATED
Solid Tumor
Institut Curie
 2025-01-20 PHASE1
NCT06337630 Not yet recruiting
Solid Tumor
Institut Curie|ProLynx LLC|Merck Sharp & Dohme LLC
 2024-06-15 Phase 1
NCT06308263 Recruiting
Solid Tumor
Merck Healthcare KGaA Darmstadt Germany an affiliate of Merck KGaA Darmstadt Germany
 2024-03-25 Phase 1
NCT05396833 Recruiting
Metastatic or Locally Advanced Unresectable Solid Tumors
EMD Serono Research & Development Institute Inc.|Merck KGaA Darmstadt Germany|EMD Serono
 2022-06-07 Phase 1
NCT04170153 Active not recruiting
Metastatic or Locally Advanced Unresectable Solid Tumors
EMD Serono Research & Development Institute Inc.|Merck KGaA Darmstadt Germany|EMD Serono
 2019-12-20 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-04-02)

Check the Tuvusertib (M1774) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tuvusertib (M1774) selectively binds to and inhibits ataxia telangiectasia and Rad3-related kinase, thereby disrupting downstream DNA damage checkpoint signaling and suppressing replication fork stabilization during cellular stress. This blockade leads to the accumulation of unresolved DNA double-strand breaks and severe genomic instability, driving selective cell death and anti-tumor efficacy in ATR-dependent malignancies such as advanced solid tumors, prostate carcinoma, and ovarian cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.