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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 weeks3 visits

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)

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

Do I qualify?Apply below to find out

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Who is running the clinical trial?

EMD Serono Research & Development Institute, Inc.Lead Sponsor

76 Previous Clinical Trials

30,830 Total Patients Enrolled

Merck KGaA, Darmstadt, GermanyIndustry Sponsor

436 Previous Clinical Trials

114,626 Total Patients Enrolled

Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

288 Previous Clinical Trials

68,945 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential dangers does M4076 pose to those receiving treatment?

"Our team at Power gave M4076 a score of 1 because the clinical trial is in Phase 1, which means there's limited evidence concerning its efficacy and safety."

Answered by AI

How many participants are receiving treatment within this trial?

"Affirmative. Clinicaltrials.gov data shows that this study, which was initially posted on May 24th 2021, is actively recruiting individuals to participate in the trial. A total of 30 participants need to be enrolled from 3 different sites."

Answered by AI

Are researchers currently accepting volunteers for this clinical study?

"Affirmative. According to clinicaltrials.gov, this experiment is currently recruiting participants and was posted on May 24th 2021 with a recent update on November 16th 2022. The research team needs 30 individuals at 3 locations for the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

First-in-human Study of M4076 in Advanced Solid Tumors (DDRiver Solid Tumors 410)

2021. "First-in-human Study of M4076 in Advanced Solid Tumors (DDRiver Solid Tumors 410)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04882917.