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Completed

NCT Number: NCT06308263

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

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.

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Key information

Conditions

Solid Tumor Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hereditary Sensory and Autonomic Neuropathies Heredodegenerative Disorders, Nervous System Nervous System Diseases Nervous System Malformations Neurodegenerative Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Polyneuropathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pharmaceutical Research Associates Magyarország Kutatás - Fejlesztési Kft., Klinikai Farmakológiai Vizsgálóhely

Budapest, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tuvusertib [14C]Tuvusertib microtracer

Drug

Participants will receive single oral dose of Tuvusertib containing a [14C] Tuvusertib microtracer solution on Day 1 of period 1 under fasted conditions.

Other names: M1774

Tuvusertib

Drug

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.

Other names: M1774

Tuvusertib + [14C]Tuvusertib microdose bolus injection

Drug

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.

Other names: M1774

Primary outcomes

  1. Period 1: Percent Urinary Recovery (feurine) Of Total Radioactivity (TRA) Over the Entire Period Of Collection

    Time frame: Pre-dose up to 312-336 hours post dose

  2. Period 1: Percent Fecal Recovery (fefeces) Of TRA Over the Entire Period Of Collection

    Time frame: Pre-dose up to 312-336 hours post-dose

  3. Period 1: Percent Total Recovery in Urine and Feces (fetotal) Of TRA Over the Entire Period of Collection

    Time frame: Pre-dose up to 312-336 hours post-dose

  4. Period 1 and 1a: Maximum Observed Plasma Concentration (Cmax) Of Tuvusertib

    Time frame: Pre-dose up to 336 hours post-dose

  5. Period 1 and 1a: Time to Reach Maximum Plasma Concentration (Tmax) Of Tuvusertib

    Time frame: Pre-dose up to 336 hours post-dose

  6. 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

    Time frame: Pre-dose up to 336 hours post-dose

  7. Period 1 and 1a: Area Under the Plasma Concentration-Time Curve (AUC) from Time Zero Extrapolated to Infinity (AUC0-inf) Of Tuvusertib

    Time frame: Pre-dose up to 336 hours post-dose

  8. Period 1 and 1a: Apparent Terminal Half-Life (t1/2) Of Tuvusertib

    Time frame: Pre-dose up to 336 hours post-dose

  9. Period 1 and 1a: Apparent Total Body Clearance (CL/F) Of Tuvusertib

    Time frame: Pre-dose up to 336 hours post-dose

  10. Period 1 and 1a: Apparent Volume of Distribution (Vz/F) Of Tuvusertib

    Time frame: Pre-dose up to 336 hours post-dose

  11. Period 1: Maximum Observed Concentration (Cmax) of TRA in Plasma and Whole Blood

    Time frame: Pre-dose up to 336 hours post-dose

  12. Period 1: Time to Reach Maximum Concentration (tmax) of TRA in Plasma and Whole blood

    Time frame: Pre-dose up to 336 hours post-dose

  13. 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

    Time frame: Pre-dose up to 336 hours post-dose

  14. Period 1: Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf) of TRA in Plasma and Whole Blood

    Time frame: Pre-dose up to 336 hours post-dose

  15. Period 1: Apparent Terminal Half-Life (t1/2) of TRA in Plasma and Whole Blood

    Time frame: Pre-dose up to 336 hours post-dose

  16. Period 1a: Ratio of Dose Normalized AUC0-infinity of Tuvusertib and 14C Tuvusertib in Plasma

    Time frame: Pre-dose up to 336 hours post-dose

  17. Period 1a: Initial Concentration (C0) at Time Zero After Bolus Intervention Administration of 14[C] Tuvusertib

    Time frame: Pre-dose up to 336 hours post-dose

  18. Period 1a: Maximum Observed Concentration (Cmax) at Intravenous Administration of 14 [C] Tuvusertib

    Time frame: Pre-dose up to 336 hours post-dose

  19. Period 1a: Total Body Clearance (CL) Following at Intravenous Administration of 14[C] Tuvusertib

    Time frame: Pre-dose up to 336 hours post-dose

  20. Period 1a: Volume of Distribution (Vz) during the terminal phase following intravenous administration of 14[C] Tuvusertib

    Time frame: Pre-dose upto 336 hours post-dose

  21. Period 1a: Volume of Distribution at Steady State (Vss) Following at Intravenous Administration of 14[C] Tuvusertib

    Time frame: Pre-dose up to 336 hours post-dose

  22. 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

    Time frame: Pre-dose up to 336 hours post-dose

  23. 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

    Time frame: Pre-dose up to 336 hours post-dose

  24. Period 1a: Apparent Terminal Half-Life (t1/2) at Intravenous Administration of 14[C] Tuvusertib

    Time frame: Pre-dose up to 336 hours post-dose

Secondary outcomes

  1. Period 1,1a,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

    Time frame: Baseline up to safety follow up (assessed up to approximately 21 months)

Sponsors and collaborators

Lead sponsor

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Industry

Registry information

Official study title

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)

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2024
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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