protocolSection identificationModule nctId: NCT06308263, orgStudyIdInfo id: MS201924_0003, secondaryIdInfos id: 2022-502940-10-00, type: OTHER, domain: EU trial number, briefTitle: M1774 Human Mass Balance Study (DDRIVER Solid Tumors 303), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2025-11-26, completionDateStruct date: 2025-11-26, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, class: INDUSTRY, descriptionModule 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., conditionsModule conditions: Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: M1774 [14C]M1774 microtracer, interventions name: M1774, outcomesModule primaryOutcomes measure: Period 1: Percent Urinary Recovery (feurine) Of Total Radioactivity (TRA) Over the Entire Period Of Collection, primaryOutcomes measure: Period 1: Percent Fecal Recovery (fefeces) Of TRA Over the Entire Period Of Collection, primaryOutcomes measure: Period 1: Percent Total Recovery in Urine and Feces (fetotal) Of TRA Over the Entire Period of Collection, primaryOutcomes measure: Period 1: Maximum Observed Plasma Concentration (Cmax) Of M1774, primaryOutcomes measure: Period 1: Time to Reach Maximum Plasma Concentration (Tmax) Of M1774, primaryOutcomes 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, primaryOutcomes measure: Period 1: Area Under the Plasma Concentration-Time Curve (AUC) from Time Zero Extrapolated to Infinity (AUC0-inf) Of M1774, primaryOutcomes measure: Period 1: Apparent Terminal Half-Life (t1/2) Of M1774, primaryOutcomes measure: Period 1: Apparent Total Body Clearance (CL/F) Of M1774, primaryOutcomes measure: Period 1: Apparent Volume of Distribution (Vz/F) Of M1774, primaryOutcomes measure: Period 1: Maximum Observed Concentration (Cmax) of TRA in Plasma and Whole Blood, primaryOutcomes measure: Period 1: Time to Reach Maximum Concentration (tmax) of TRA in Plasma and Whole blood, primaryOutcomes 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, primaryOutcomes measure: Period 1: Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf) of TRA in Plasma and Whole Blood, primaryOutcomes measure: Period 1: Apparent Terminal Half-Life (t1/2) of TRA in Plasma and Whole Blood, secondaryOutcomes 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, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pharmaceutical Research Associates Magyarország Kutatás - Fejlesztési Kft., Klinikai Farmakológiai Vizsgálóhely, status: RECRUITING, city: Budapest, country: Hungary, geoPoint lat: 47.49801, lon: 19.03991, locations facility: Észak Pesti Centrum Kórház-Honvédkórház, Onkológiai Osztály, status: NOT_YET_RECRUITING, city: Budapest, country: Hungary, geoPoint lat: 47.49801, lon: 19.03991, hasResults: False