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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 time from randomization to final assessment at end of safety follow-up visit (up to a maximum of approximately 1 years)
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective for treating solid tumors. The first part will test increasing doses to find the maximum tolerated dose. The second part will test how the drug is affected by food.

Eligible Conditions
  • Advanced Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from randomization to final assessment at end of safety follow-up visit (up to a maximum of approximately 1 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from randomization to final assessment at end of safety follow-up visit (up to a maximum of approximately 1 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1A: Number of Participants With Clinical Significant Changes in Vital Signs, Laboratory Parameters, and 12-Lead Electrocardiogram (ECG) Findings
Part 1A: Occurrence of Adverse Events (AEs) and Treatment-Related AEs
Part 1A: Occurrence of Dose Limiting Toxicities (DLTs) During the DLT Observation Period
+2 more
Secondary outcome measures
Part 1A and 1B: Area Under Plasma Concentration-Time Curve (AUC) From Time Zero (= Dosing Time) to the Last Sampling Time (tlast) of M4076
Part 1A and Part 1B: Absolute and Relative Changes From Baseline in Ataxia-Telangiectasia Mutated (ATM) Pathway Readouts Assessed by Flow Cytometry and Immunohistochemistry
Part 1A and Part 1B: Area Under Plasma Concentration (AUC) From Time Zero (Dosing Time) Extrapolated to Infinity (AUC0-inf) of M4076
+4 more

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
78 Previous Clinical Trials
31,014 Total Patients Enrolled
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
438 Previous Clinical Trials
114,810 Total Patients Enrolled
Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
291 Previous Clinical Trials
69,425 Total Patients Enrolled
~7 spots leftby Jun 2025
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