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A phase 1 open-label trial evaluating M4076 in patients with advanced solid tumors (DDRiver™ Solid Tumors 410)1
 

ClinicalTrials.gov: NCT04882917

Location: North America

Status: ACTIVE, NOT RECRUITING

GROUP102 SOLID TUMORS

M4076 is an investigational orally administered ATP-competitive inhibitor of ataxia telangiectasia mutated (ATM) protein kinase, a key component of the DNA damage response (DDR) pathway. In preclinical studies, M4076 demonstrated subnanomolar potency and selectivity for ATM1-3

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Key inclusion criteriaa

  • Advanced solid tumors, for which standard-of-care therapy does not exist or is considered insufficiently effective, or no tolerance of standard of care

  • ECOG PS of ≤1

  • Paired tumor biopsies (if not contraindicated) for part 1B
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Key exclusion criteriaa

  • Clinically significant uncontrolled intercurrent illness

  • Ataxia telangiectasia

  • ATM mutations

Study design | North America

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M4076 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 M4076, and it includes information about how the safety and efficacy of M4076 will be measured and evaluated. Therefore, it is important to understand that M4076 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 European Medicines Agency or the US Food and Drug Administration, and there is no guarantee that M4076 will be approved in the sought-after indication by any health authority worldwide.

For a list of all inclusion and exclusion criteria, please visit https://clinicaltrials.gov/ct2/show/NCT04882917.
Participants will receive M4076 at the dose and schedule determined as the RDE in part 1A.
Assessed by investigator per RECIST version 1.1.

ATM, ataxia telangiectasia mutated; ATP, adenosine triphosphate; DDR, DNA damage response; DLT, dose-limiting toxicity; DNA, deoxyribonucleic acid; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; OR, objective response; PFS, progression-free survival; PK, pharmacokinetics; QD, once daily; RDE, recommended dose for expansion; RECIST, Response Evaluation Criteria in Solid Tumors.

References
1. ClinicalTrials.gov. Accessed June 28, 2023. https://clinicaltrials.gov/ct2/show/NCT04882917; 2. Zimmermann A, et al. Mol Cancer Ther. 2022;21(6):859-870;
3. Blackford N, Jackson P. Mol Cell. 2017;6(6):801-817.