NCT06308263

Tuvusertib (M1774) Human Mass Balance and Absolute Bioavailability Study (DDRIVER Solid Tumors 303)

Phase 1 Study to Evaluate the Mass Balance, Pharmacokinetics, Metabolism, Excretion and Absolute Bioavailability of Tuvusertib (M1774) Containing Microtracer 14C Tuvusertib in Participants With Advanced Solid Tumors (DDRIVER Solid Tumors 303)

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. The purpose of Period 1a is to assess the extent of ABA of tuvusertib and the mass balance, PK, metabolism, and elimination of 14C-tuvusertib after iv dosing in participants with advanced solid tumors. After either Period 1 or Period 1a; participants may enter an optional extension phase (Period 2) where participants will receive tuvusertib until disease progression or other criteria for study intervention discontinuation are met.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	Tuvusertib [14C]Tuvusertib microtracer	Participants will receive single oral dose of Tuvusertib containing a \[14C\] Tuvusertib microtracer solution on Day 1 of period 1 under fasted conditions.
DRUG	Tuvusertib	Participants will also receive a single oral dose of Tuvusertib on Day 1 of Period 1 or Period 1a, and daily single oral dose of Tuvusertib for 2 weeks in 21 days cycle of Period 2.
DRUG	Tuvusertib + [14C]Tuvusertib microdose bolus injection	In Period 1a, participants will receive on Day 1 of Period 1 a single oral dose of tuvusertib and an intravenous (IV) (14C) tuvusertib microdose as bolus injection.

Timeline

• Start date: 2024-03-25
• Primary completion: 2026-03-23
• Completion: 2026-03-23
• First posted: 2024-03-13
• Last updated: 2026-01-30

Locations

1 site across 1 country: Hungary