M1774 Human Mass Balance Study (DDRIVER Solid Tumors 303)

Solid Tumor Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06308263
• Other study ID #: MS201924_0003
• Secondary ID: 2022-502940-10-0
• Status: Recruiting
• Phase: Phase 1
• Start date: March 25, 2024
• Est. completion date: November 26, 2025

Study information

• Verified date: April 2024
• Source: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
• Contact: Communication Center
• Phone: +49 6151 72 5200
• Email: service[@]emdgroup.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: November 26, 2025
• Est. primary completion date: November 26, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Are histologically proven advanced solid tumors that are considered appropriate for treatment in Period 2 of this study, for which no effective standard therapy exists, or standard therapy has failed or cannot be tolerated
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) less than or equal to 1 (<=) 1
• Have evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at Screening
• Are capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol
• Other protocol defined inclusion criteria could apply

Exclusion Criteria:

• Uncontrolled or poorly controlled arterial hypertension, symptomatic congestive heart failure (New York Heart Association Classification more than equal to (>=) Class III), uncontrolled cardiac arrhythmia, calculated Corrected QT interval (QTc) average using the QT Interval Corrected Using Fridericia's Formula (QTcF) more than (>) 480 msec; unstable angina pectoris, myocardial infarction, or a coronary revascularization procedure, cerebral vascular accident, transient ischemic attack, or any other significant vascular disease within 180 days of study intervention start
• Presence of toxicities due to prior anticancer therapies (e.g. radiotherapy, chemotherapy, immunotherapies, Et cetera (etc.)) that do not recover to (<=) Grade 1 with the exception of toxicities that do not pose a safety risk to the participant in the judgment of the Investigator (e.g. ongoing Grade 2 alopecia)
• Treatment with live or live attenuated vaccine within 30 days of dosing (non-replicating vector vaccines are permitted)
• Participation in a study involving administration of 14C-labeled compound(s) within last 6 months prior to start of study intervention
• Other protocol defined exclusion criteria could apply

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• M1774 [14C]M1774 microtracer
Participants will receive single oral dose of M1774 containing a [14C]M1774 microtracer solution on day 1 of period 1 under fasted conditions.
• M1774
Participants will receive a single oral dose of M1774 on Day 1 of Period 1, and daily single oral dose of M1774 for 2 weeks in 21 days cycle of Period 2.

Locations

Country	Name	City	State
Hungary	Észak Pesti Centrum Kórház-Honvédkórház, Onkológiai Osztály	Budapest
Hungary	Pharmaceutical Research Associates Magyarország Kutatás - Fejlesztési Kft., Klinikai Farmakológiai Vizsgálóhely	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Period 1: Percent Urinary Recovery (feurine) Of Total Radioactivity (TRA) Over the Entire Period Of Collection		Pre-dose up to 312-336 hours post dose
Primary	Period 1: Percent Fecal Recovery (fefeces) Of TRA Over the Entire Period Of Collection		Pre-dose up to 312-336 hours post-dose
Primary	Period 1: Percent Total Recovery in Urine and Feces (fetotal) Of TRA Over the Entire Period of Collection		Pre-dose up to 312-336 hours post-dose
Primary	Period 1: Maximum Observed Plasma Concentration (Cmax) Of M1774		Pre-dose up to 336 hours post-dose
Primary	Period 1: Time to Reach Maximum Plasma Concentration (Tmax) Of M1774		Pre-dose up to 336 hours post-dose
Primary	Period 1: Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Quantifiable Concentration (AUC0-tlast) Of M1774		Pre-dose up to 336 hours post-dose
Primary	Period 1: Area Under the Plasma Concentration-Time Curve (AUC) from Time Zero Extrapolated to Infinity (AUC0-inf) Of M1774		Pre-dose up to 336 hours post-dose
Primary	Period 1: Apparent Terminal Half-Life (t1/2) Of M1774		Pre-dose up to 336 hours post-dose
Primary	Period 1: Apparent Total Body Clearance (CL/F) Of M1774		Pre-dose up to 336 hours post-dose
Primary	Period 1: Apparent Volume of Distribution (Vz/F) Of M1774		Pre-dose up to 336 hours post-dose
Primary	Period 1: Maximum Observed Concentration (Cmax) of TRA in Plasma and Whole Blood		Pre-dose up to 336 hours post-dose
Primary	Period 1: Time to Reach Maximum Concentration (tmax) of TRA in Plasma and Whole blood		Pre-dose up to 336 hours post-dose
Primary	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		Pre-dose up to 336 hours post-dose
Primary	Period 1: Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf) of TRA in Plasma and Whole Blood		Pre-dose up to 336 hours post-dose
Primary	Period 1: Apparent Terminal Half-Life (t1/2) of TRA in Plasma and Whole Blood		Pre-dose up to 336 hours post-dose
Secondary	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		Baseline up to safety follow up (assessed up to approximately 21 months)

External Links

•   Trial Awareness and Transparency website