At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 22 enrolled
Drug / intervention
M4076drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A First-in-human, Phase I, Open-label Study of the ATM Inhibitor M4076 in Participants With Advanced Solid Tumors (DDRiver Solid Tumors 410)
EMD Serono Research & Development Institute, Inc.·interventional·Posted May 12, 2021·Updated Mar 7, 2025
In Brief
A Phase 1 clinical trial evaluating M4076 for Advanced Solid Tumors. Completed, enrolled 22 participants across 3 sites in 2 countries.
Detailed Summary
The purpose of this study was to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), maximum tolerated dose (MTD) (if reached) and early signs of efficacy of M4076 monotherapy in participants with solid tumors in dose escalation (Part 1A). Once the recommended dose for expansion (RDE) was declared in Part 1A, a preliminary food effect cohort, Part 1B, will follow at the RDE determined from Part 1A.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumors
CountriesCanada, United States
CollaboratorsMerck KGaA, Darmstadt, Germany
Timeline
Phase 1CompletedFinished
20222023202420252026
First PostedMay 2021
Enrollment StartMay 2021
Primary CompletionMar 2023
TodayJul 2026
First PostedMay 12, 2021
Enrollment StartMay 24, 2021
Primary CompletionMar 31, 2023
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 5.1 years ago
Interventions
M4076drug
M4076 was administered orally.