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.
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Period 1: Percent Urinary Recovery (feurine) Of Total Radioactivity (TRA) Over the Entire Period Of Collection
Timeframe: Pre-dose up to 312-336 hours post dose
Period 1: Percent Fecal Recovery (fefeces) Of TRA Over the Entire Period Of Collection
Timeframe: Pre-dose up to 312-336 hours post-dose
Period 1: Percent Total Recovery in Urine and Feces (fetotal) Of TRA Over the Entire Period of Collection
Timeframe: Pre-dose up to 312-336 hours post-dose
Period 1 and 1a: Maximum Observed Plasma Concentration (Cmax) Of Tuvusertib
Timeframe: Pre-dose up to 336 hours post-dose
Period 1 and 1a: Time to Reach Maximum Plasma Concentration (Tmax) Of Tuvusertib
Timeframe: Pre-dose up to 336 hours post-dose
Period 1 and 1a: Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Quantifiable Concentration (AUC0-tlast) Of Tuvusertib
Timeframe: Pre-dose up to 336 hours post-dose
Period 1 and 1a: Area Under the Plasma Concentration-Time Curve (AUC) from Time Zero Extrapolated to Infinity (AUC0-inf) Of Tuvusertib
Timeframe: Pre-dose up to 336 hours post-dose
Period 1 and 1a: Apparent Terminal Half-Life (t1/2) Of Tuvusertib
Timeframe: Pre-dose up to 336 hours post-dose
Period 1 and 1a: Apparent Total Body Clearance (CL/F) Of Tuvusertib
Timeframe: Pre-dose up to 336 hours post-dose
Period 1 and 1a: Apparent Volume of Distribution (Vz/F) Of Tuvusertib
Timeframe: Pre-dose up to 336 hours post-dose
Period 1: Maximum Observed Concentration (Cmax) of TRA in Plasma and Whole Blood
Timeframe: Pre-dose up to 336 hours post-dose
Period 1: Time to Reach Maximum Concentration (tmax) of TRA in Plasma and Whole blood
Timeframe: Pre-dose up to 336 hours post-dose
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
Timeframe: Pre-dose up to 336 hours post-dose
Period 1: Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf) of TRA in Plasma and Whole Blood
Timeframe: Pre-dose up to 336 hours post-dose
Period 1: Apparent Terminal Half-Life (t1/2) of TRA in Plasma and Whole Blood
Timeframe: Pre-dose up to 336 hours post-dose
Period 1a: Ratio of Dose Normalized AUC0-infinity of Tuvusertib and 14C Tuvusertib in Plasma
Timeframe: Pre-dose up to 336 hours post-dose
Period 1a: Initial Concentration (C0) at Time Zero After Bolus Intervention Administration of 14[C] Tuvusertib
Timeframe: Pre-dose up to 336 hours post-dose
Period 1a: Maximum Observed Concentration (Cmax) at Intravenous Administration of 14 [C] Tuvusertib
Timeframe: Pre-dose up to 336 hours post-dose
Period 1a: Total Body Clearance (CL) Following at Intravenous Administration of 14[C] Tuvusertib
Timeframe: Pre-dose up to 336 hours post-dose
Period 1a: Volume of Distribution (Vz) during the terminal phase following intravenous administration of 14[C] Tuvusertib
Timeframe: Pre-dose upto 336 hours post-dose
Period 1a: Volume of Distribution at Steady State (Vss) Following at Intravenous Administration of 14[C] Tuvusertib
Timeframe: Pre-dose up to 336 hours post-dose
Period 1a: Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Quantifiable Concentration (AUC0-tlast) at Intravenous Administration of 14[C] Tuvusertib
Timeframe: Pre-dose up to 336 hours post-dose
Period 1a: Area Under the Plasma Concentration-Time Curve (AUC) from Time Zero Extrapolated to Infinity (AUC0-inf) at Intravenous Administration of 14[C] Tuvusertib
Timeframe: Pre-dose up to 336 hours post-dose
Period 1a: Apparent Terminal Half-Life (t1/2) at Intravenous Administration of 14[C] Tuvusertib
Timeframe: Pre-dose up to 336 hours post-dose