Your session is about to expire
← Back to Search
DNA Damage Response Inhibitor
First-in-human Study of M4076 in Advanced Solid Tumors (DDRiver Solid Tumors 410)
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
No Placebo-Only Group
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-dose up to 14 months post-dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose up to 14 months post-dose
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
85 Previous Clinical Trials
22,703 Total Patients Enrolled
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
446 Previous Clinical Trials
114,872 Total Patients Enrolled
Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
300 Previous Clinical Trials
61,149 Total Patients Enrolled