Welcome to the DDRiver™ Clinical Trials Program

If you are an HCP, click on “I’m a Healthcare Professional"

If you are a patient, please click on “I’m not a Healthcare Professional”

Leaving DDRiver™ website

You are leaving DDRiver™ Clinical Trials page. This link will take you to a website where our Terms of Use do not apply. EMD Serono does not control the content of these websites.

A phase 1B open-label trial evaluating tuvusertib (M1774) in combination with DNA damage response inhibitors or immune checkpoint inhibitors in patients with metastatic or locally advanced unresectable solid tumors (DDRiver™ Solid Tumors 320)1
 

ClinicalTrials.govNCT05396833

Location: North America and Europe

Status:NOW ENROLLING

GROUP SOLID TUMORS

Tuvusertib (M1774) is an investigational orally administered inhibitor of ataxia telangiectasia and Rad3-related (ATR) protein kinase, a key component of the DNA damage response (DDR) pathway. Based on preclinical studies, tuvusertib (M1774) is a highly selective and potent inhibitor of ATR activity1,2

tick

Key inclusion criteriaa

  • Metastatic or locally advanced unresectable solid tumors refractory to standard therapy, or patients with no tolerance to standard of care

  • ECOG PS of ≤1

  • Adequate hematologic, hepatic, and renal function

tick1

Key exclusion criteriaa

  • Any other clinical condition, including any uncontrolled disease state, that the investigator believes constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study

  • Any additional malignancy that is progressing and/or requires active treatment

  • Any chronic gastrointestinal disease that may preclude adequate absorption of oral medications

  • Previous organ transplant

Study design | North America and Europe

graph

How do I enroll patients in DDRiver™ Solid Tumors 320?

 

Please contact us for more information on this trial, including how to enroll your patients

LOCATION CITY Location POSTAL CODE COUNTRY STATUS

Tuvusertib (M1774) is being investigated in this clinical trial. This means that it has not been shown to be safe or effective for any purpose or disease. This page describes one of the clinical trials for tuvusertib (M1774), and it includes information about how the safety and efficacy of tuvusertib (M1774) will be measured and evaluated. Therefore, it is important to understand that tuvusertib (M1774) is not a treatment or therapy for cancer or any other disease, its use has not been approved by any health authority, such as the US Food and Drug Administration, and there is no guarantee that tuvusertib (M1774) will be approved in the sought-after indication by any health authority worldwide.

a For a list of all inclusion and exclusion criteria and primary and secondary endpoints, please visit https://clinicaltrials.gov/ct2/show/NCT05396833.
b Tuvusertib (M1774) will be administered orally once daily over a defined period of time in part A1 and part B1 until disease progression, death, discontinuation, or end of study.
c M4076 will be administered orally once daily over a defined period of time in part A1 until disease progression, death, discontinuation, or end of study.
d Avelumab will be administered by intravenous infusion daily over a defined period of time in part B1 until disease progression, death, discontinuation, or end of study.
e Assessed by investigator per RECIST version 1.1.

ADA, antidrug antibody; ATR, ataxia telangiectasia mutated and Rad3 related; DDR, DNA damage response; DLT, dose-limiting toxicity; DNA, deoxyribonucleic acid; ECOG PS, Eastern Cooperative Oncology Group performance status; OR, objective response; PD, pharmacodynamics; PK, pharmacokinetics; QD, once daily; RECIST, Response Evaluation Criteria in Solid Tumors.

References
1. ClinicalTrials.gov. Accessed June 28, 2023. https://clinicaltrials.gov/ct2/show/NCT04170153; 2. Roidos P, et al. Nat Commun. 2020;11(1):4077.