Spots Global Cancer Trial Database for M1774 Human Mass Balance Study (DDRIVER Solid Tumors 303)
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Trial Identification
Brief Title: M1774 Human Mass Balance Study (DDRIVER Solid Tumors 303)
Official Title: Phase 1 Study to Evaluate the Mass Balance, Pharmacokinetics, Metabolism and Excretion of M1774 Containing Microtracer [14C] M1774 in Participants With Advanced Solid Tumors (DDRIVER Solid Tumors 303)
Study ID: NCT06308263
Conditions
Study Description
Brief Summary: This is a single sequence 2-period open label study in participants with advanced solid tumors. The purpose of Period 1 of this study is to assess the mass balance to determine drug-related entities present in circulation and excreta and provide a comprehensive understanding of biotransformation pathways and clearance mechanisms in participants with advanced solid tumors. Thereafter, participants may enter an optional extension phase (Period 2) where participants will receive M1774 until disease progression or other criteria for study intervention discontinuation are met.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Pharmaceutical Research Associates Magyarország Kutatás - Fejlesztési Kft., Klinikai Farmakológiai Vizsgálóhely, Budapest, , Hungary
Észak Pesti Centrum Kórház-Honvédkórház, Onkológiai Osztály, Budapest, , Hungary
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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