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

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

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

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

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