M1774 Human Mass Balance Study (DDRIVER Solid Tumors 303) - Trial NCT06308263
Access comprehensive clinical trial information for NCT06308263 through Pure Global AI's free database. This Phase 1 trial is sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany and is currently Recruiting. The study focuses on Solid Tumor. Target enrollment is 6 participants.
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Study Focus
Sponsor & Location
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Timeline & Enrollment
Phase 1
Mar 25, 2024
Nov 26, 2025
Primary Outcome
Period 1: Percent Urinary Recovery (feurine) Of Total Radioactivity (TRA) Over the Entire Period Of Collection,Period 1: Percent Fecal Recovery (fefeces) Of TRA Over the Entire Period Of Collection,Period 1: Percent Total Recovery in Urine and Feces (fetotal) Of TRA Over the Entire Period of Collection,Period 1: Maximum Observed Plasma Concentration (Cmax) Of M1774,Period 1: Time to Reach Maximum Plasma Concentration (Tmax) Of M1774,Period 1: Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Quantifiable Concentration (AUC0-tlast) Of M1774,Period 1: Area Under the Plasma Concentration-Time Curve (AUC) from Time Zero Extrapolated to Infinity (AUC0-inf) Of M1774,Period 1: Apparent Terminal Half-Life (t1/2) Of M1774,Period 1: Apparent Total Body Clearance (CL/F) Of M1774,Period 1: Apparent Volume of Distribution (Vz/F) Of M1774,Period 1: Maximum Observed Concentration (Cmax) of TRA in Plasma and Whole Blood,Period 1: Time to Reach Maximum Concentration (tmax) of TRA in Plasma and Whole blood,Period 1: Area Under Concentration-Time Curve from Time Zero to the Time of the Last Quantifiable Concentration (AUC0-tlast) of TRA in Plasma and Whole Blood,Period 1: Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf) of TRA in Plasma and Whole Blood,Period 1: Apparent Terminal Half-Life (t1/2) of TRA in Plasma and Whole Blood
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06308263
Non-Device Trial