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Tuvusertib Tuvusertib microtracer

Phase 1

Solid Tumor | Small molecule | Oncology |Merck KGaA|Last Updated: Apr 23, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

Tuvusertib Tuvusertib microtracer · 1 trial · 1 indication

Phase 1 1
NCT06308263Tuvusertib (M1774) Human Mass Balance and Absolute Bioavailability Study (DDRIVER Solid Tumors 303)Solid Tumor
COMPLETED12 Analytics
PHASE1COMPLETED
Tuvusertib (M1774) Human Mass Balance and Absolute Bioavailability Study (DDRIVER Solid Tumors 303)
Solid Tumor
NCT0630826312
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Study Endpoints

Primary Endpoints

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
Period 1: Percent Fecal Recovery (fefeces) Of TRA Over the Entire Period Of Collection
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
Pre-dose up to 312-336 hours post-dose
Period 1 and 1a: Maximum Observed Plasma Concentration (Cmax) Of Tuvusertib
Pre-dose up to 336 hours post-dose
Period 1 and 1a: Time to Reach Maximum Plasma Concentration (Tmax) Of Tuvusertib
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
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
Pre-dose up to 336 hours post-dose
Period 1 and 1a: Apparent Terminal Half-Life (t1/2) Of Tuvusertib
Pre-dose up to 336 hours post-dose
Period 1 and 1a: Apparent Total Body Clearance (CL/F) Of Tuvusertib
Pre-dose up to 336 hours post-dose
Period 1 and 1a: Apparent Volume of Distribution (Vz/F) Of Tuvusertib
Pre-dose up to 336 hours post-dose
Period 1: Maximum Observed Concentration (Cmax) of TRA in Plasma and Whole Blood
Pre-dose up to 336 hours post-dose
Period 1: Time to Reach Maximum Concentration (tmax) of TRA in Plasma and Whole blood
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
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
Pre-dose up to 336 hours post-dose
Period 1: Apparent Terminal Half-Life (t1/2) of TRA in Plasma and Whole Blood
Pre-dose up to 336 hours post-dose
Period 1a: Ratio of Dose Normalized AUC0-infinity of Tuvusertib and 14C Tuvusertib in Plasma
Pre-dose up to 336 hours post-dose
Period 1a: Initial Concentration (C0) at Time Zero After Bolus Intervention Administration of 14[C] Tuvusertib
Pre-dose up to 336 hours post-dose
Period 1a: Maximum Observed Concentration (Cmax) at Intravenous Administration of 14 [C] Tuvusertib
Pre-dose up to 336 hours post-dose
Period 1a: Total Body Clearance (CL) Following at Intravenous Administration of 14[C] Tuvusertib
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
Pre-dose upto 336 hours post-dose
Period 1a: Volume of Distribution at Steady State (Vss) Following at Intravenous Administration of 14[C] Tuvusertib
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
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
Pre-dose up to 336 hours post-dose
Period 1a: Apparent Terminal Half-Life (t1/2) at Intravenous Administration of 14[C] Tuvusertib
Pre-dose up to 336 hours post-dose

Secondary Endpoints

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
Baseline up to safety follow up (assessed up to approximately 21 months)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Period 1: Mass Balance: Tuvusertib + [14C]Tuvusertib microtracerEXPERIMENTAL -
Period 1a: Absolute Bioavailability: Tuvusertib + [14C]Tuvusertib microdose bolus injectionEXPERIMENTAL -
Period 2: TuvusertibEXPERIMENTAL -

Interventions

NameTypeDescription
Tuvusertib [14C]Tuvusertib microtracerDRUGParticipants will receive single oral dose of Tuvusertib containing a \[14C\] Tuvusertib microtracer solution on Day 1 of period 1 under fasted conditions.
TuvusertibDRUGParticipants 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.
Tuvusertib + [14C]Tuvusertib microdose bolus injectionDRUGIn 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.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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 Statu...

Countries:Hungary
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumor")

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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Frequently asked questions about Tuvusertib Tuvusertib microtracer

What is Tuvusertib used for?

Tuvusertib is an investigational small molecule being studied for the treatment of solid tumors. It is currently in Phase 1 clinical development. The drug is being evaluated in a clinical trial involving patients with solid tumors to assess its pharmacokinetics and bioavailability.

Who makes Tuvusertib?

Tuvusertib is being developed by Merck KGaA, a pharmaceutical company. The company's stock is traded under the ticker symbol MKGAF. Merck KGaA is conducting clinical trials to evaluate the safety and efficacy of Tuvusertib in patients with solid tumors.

What phase is Tuvusertib in?

Tuvusertib is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is designed to study the drug's mass balance and absolute bioavailability in patients with solid tumors.

What clinical trials is Tuvusertib in?

Tuvusertib is being studied in a Phase 1 clinical trial with the identifier NCT06308263. The trial is titled 'Tuvusertib (M1774) Human Mass Balance and Absolute Bioavailability Study (DDRIVER Solid Tumors 303)' and has been completed. It enrolled 12 participants with solid tumors in Hungary.

Is Tuvusertib the same as M1774?

Yes, Tuvusertib is also known as M1774. The clinical trial NCT06308263 refers to the drug as 'Tuvusertib (M1774)', confirming that both names are used interchangeably for the same investigational drug being developed by Merck KGaA.