Status:
COMPLETED
First-in-human Study of M4076 in Advanced Solid Tumors (DDRiver Solid Tumors 410)
Lead Sponsor:
EMD Serono Research & Development Institute, Inc.
Collaborating Sponsors:
Merck KGaA, Darmstadt, Germany
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study was to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), maximum tolerated dose (MTD) (if reached) and early signs of efficacy of M4076 monoth...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04882917
Start Date
May 24 2021
End Date
March 31 2023
Last Update
March 7 2025
Active Locations (3)
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1
MD Anderson Center
Houston, Texas, United States, 77030
2
NEXT Oncology
San Antonio, Texas, United States, 78229
3
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 1Z5