nctId: NCT06308263 id: MS201924_0003 id: 2022-502940-10-00 type: OTHER domain: EU trial number briefTitle: M1774 Human Mass Balance Study (DDRIVER Solid Tumors 303) overallStatus: RECRUITING date: 2024-03-25 date: 2025-11-26 date: 2025-11-26 date: 2024-03-13 date: 2024-04-26 name: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany class: INDUSTRY briefSummary: 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. conditions: Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: M1774 [14C]M1774 microtracer name: M1774 measure: Period 1: Percent Urinary Recovery (feurine) Of Total Radioactivity (TRA) Over the Entire Period Of Collection measure: Period 1: Percent Fecal Recovery (fefeces) Of TRA Over the Entire Period Of Collection measure: Period 1: Percent Total Recovery in Urine and Feces (fetotal) Of TRA Over the Entire Period of Collection measure: Period 1: Maximum Observed Plasma Concentration (Cmax) Of M1774 measure: Period 1: Time to Reach Maximum Plasma Concentration (Tmax) Of M1774 measure: Period 1: Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Quantifiable Concentration (AUC0-tlast) Of M1774 measure: Period 1: Area Under the Plasma Concentration-Time Curve (AUC) from Time Zero Extrapolated to Infinity (AUC0-inf) Of M1774 measure: Period 1: Apparent Terminal Half-Life (t1/2) Of M1774 measure: Period 1: Apparent Total Body Clearance (CL/F) Of M1774 measure: Period 1: Apparent Volume of Distribution (Vz/F) Of M1774 measure: Period 1: Maximum Observed Concentration (Cmax) of TRA in Plasma and Whole Blood measure: Period 1: Time to Reach Maximum Concentration (tmax) of TRA in Plasma and Whole blood measure: 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 measure: Period 1: Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf) of TRA in Plasma and Whole Blood measure: Period 1: Apparent Terminal Half-Life (t1/2) of TRA in Plasma and Whole Blood measure: Period 1,2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Treatment-Related AEs, Abnormal Laboratory Parameters, abnormal Vital Signs and abnormal 12-Lead Electrocardiogram (ECG) Findings sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pharmaceutical Research Associates Magyarország Kutatás - Fejlesztési Kft., Klinikai Farmakológiai Vizsgálóhely status: RECRUITING city: Budapest country: Hungary lat: 47.49801 lon: 19.03991 facility: Észak Pesti Centrum Kórház-Honvédkórház, Onkológiai Osztály status: NOT_YET_RECRUITING city: Budapest country: Hungary lat: 47.49801 lon: 19.03991 hasResults: False