NCT06308263

M1774 Human Mass Balance Study (DDRIVER Solid Tumors 303)

Name: Clinical Trial NCT06308263
Creator: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Keywords: Solid Tumor, M1774 [14C]M1774 microtracer, Phase 1, drug, clinical trial, Hungary

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)

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany·Phase 1·ClinicalTrials.gov·drugRecruiting

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Study focus

Disease/Condition: Solid Tumor
Drug/Device/Intervention: M1774 [14C]M1774 microtracer
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Location: Budapest,Budapest, Hungary

Timeline & enrollment

Phase: Phase 1
Start date: Mar 25, 2024
End date: Nov 26, 2025
Enrollment: 6 participants

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

Malignant neoplasm: Connective and soft tissue, unspecifiedCarcinoma in situ, unspecifiedMalignant neoplasm: ParametriumMalignant neoplasm of other connective and soft tissueMalignant neoplasm: Lip, unspecified, inner aspect

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06308263
Type: Non-Device Trial

About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.