Spots Global Cancer Trial Database for First-in-human Study of M4076 in Advanced Solid Tumors (DDRiver Solid Tumors 410)
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Trial Identification
Brief Title: First-in-human Study of M4076 in Advanced Solid Tumors (DDRiver Solid Tumors 410)
Official Title: A First-in-human, Phase I, Open-label Study of the ATM Inhibitor M4076 in Participants With Advanced Solid Tumors (DDRiver Solid Tumors 410)
Study ID: NCT04882917
Conditions
Interventions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
MD Anderson Center, Houston, Texas, United States
NEXT Oncology, San Antonio, Texas, United States
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Contact Details
Name: Medical Responsible
Affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Role: STUDY_DIRECTOR
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