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

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), maximum tolerated dose (MTD) (if reached) and early signs of efficacy of M4076 monotherapy in participants with solid tumors in dose escalation (Part 1A). Once the recommended dose for expansion (RDE) is declared in Part 1A, a preliminary food effect cohort, Part 1B, will follow at the RDE determined from Part 1A.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMD Serono Research & Development Institute, Inc.
• Collaborator: Merck KGaA, Darmstadt, Germany

Criteria

Inclusion Criteria:

• Participants with advanced solid tumors, for whom no standard of care therapy exists or for whom is not considered sufficiently effective, or who cannot tolerate standard of care

• Participants with Eastern Cooperative Oncology Group Performance status 0 or 1

• Adequate hematological, hepatic, and renal function as defined in the protocol

• Participants in Part 1B (the preliminary food effect assessment) must agree to provide paired tumor biopsies if not contraindicated for medical reasons

• Other protocol defined inclusion criteria could apply

Exclusion Criteria:

• Clinically significant (i.e., active) uncontrolled intercurrent illness including, but not limited to:

1. Active infection (i.e., requiring systemic antibiotics or antifungals)

2. Uncontrolled arterial hypertension

3. Severe cardiac arrhythmia requiring medication

4. Cerebral vascular accident/stroke

• Has known ataxia telangiectasia

• Participants with tumors harboring previously identified ATM mutations

• Participants with hypersensitivity to the active substance or to any of the excipients of M4076

• Other protocol defined exclusion criteria could apply