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DNA Damage Response Inhibitor

M4076 for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by EMD Serono Research & Development Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose up to 14 months post-dose
Awards & highlights

Summary

This trial is testing a new drug called M4076 on patients with solid tumors. The goal is to see how the drug is processed by the body, its effects, safe dosage levels, and early signs of effectiveness.

Eligible Conditions
  • Advanced Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose up to 14 months post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose up to 14 months post-dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Part 1A and Part 1B: Absolute and Relative Changes From Baseline in Ataxia-Telangiectasia Mutated (ATM) Pathway Readouts Assessed by Flow Cytometry and Immunohistochemistry

Trial Design

2Treatment groups
Experimental Treatment
Group I: Experimental: Preliminary Food Effect Assessment Cohort (Part 1B): M4076Experimental Treatment1 Intervention
Participants in food effect assessment will receive M4076 at the dose and schedule determined as recommended dose for expansion (RDE) in Part 1A. A single dose of M4076 will be administered on Day -7 under a fed or fasted condition, followed by a 1-week washout period.
Group II: Experimental: Dose Escalation Cohort (Part 1A): M4076 MonotherapyExperimental Treatment1 Intervention
Participants will receive M4076 film coated tablet at escalated doses orally, once daily under fasting condition until disease progression, death, Adverse events (AEs) leading to discontinuation of study intervention(s), or withdrawal of consent, whichever occurs first.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
M4076
2021
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

EMD Serono Research & Development Institute, Inc.Lead Sponsor
82 Previous Clinical Trials
22,596 Total Patients Enrolled
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
440 Previous Clinical Trials
114,544 Total Patients Enrolled
Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
295 Previous Clinical Trials
60,950 Total Patients Enrolled
~7 spots leftby Sep 2025
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