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

  • STATUS
    Recruiting
  • days left to enroll
    71
  • participants needed
    30
  • sponsor
    EMD Serono Research & Development Institute, Inc.
Updated on 9 May 2022

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.

Details
Condition Advanced Solid Tumors
Treatment M4076
Clinical Study IdentifierNCT04882917
SponsorEMD Serono Research & Development Institute, Inc.
Last Modified on9 May 2022

Eligibility

Yes No Not Sure

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
Active infection (i.e., requiring systemic antibiotics or antifungals)
Uncontrolled arterial hypertension
Severe cardiac arrhythmia requiring medication
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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