M1774 - Metastatic or Locally Advanced Unresectable Solid Tumors | Phase 1 | Merck & Company, Inc. | BiopharmaWatch

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M1774

Phase 1

Metastatic or Locally Advanced Unresectable Solid Tumors | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: May 7, 2026

Success Probability

Approval Probability 71%

TA Base Rate26%

Adjusted LOA41%

ML RiskLOW_RISK

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Market & Valuation

rNPV $3.2B

Market Size $9.4B

Revenue Basis $1.6B

Competitors 6

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Trial Design

CONTROLLEDBiomarker

Total Trials1

Total Enrollment161

FDA Designations

No designations recorded

Clinical Trials (1)

NCT ID	Title	Phase	Status	Enrollment	Velocity	Design	Start	Completion	Last Updated	Sites	Countries
NCT04170153	Tuvusertib (M1774) in Participants With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 301)	PHASE1	ACTIVE NOT_RECRUITING	161	—	—	Dec 20, 2019	Jul 30, 2026	May 7, 2026	16	United States, China +3

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Study Endpoints

Primary Endpoints

Part A1, A4 and A5: Occurrence of Dose-Limiting Toxicities (DLTs) During the DLT Observation Period

Day 1 to Day 21 of Cycle 1 (Each Cycle is of 21 days)

Part A1, A3, A4, A5 and B1: Occurrence of Treatment-emergent Adverse Events (TEAEs), Treatment-related Adverse Events (AEs) and Death According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0

Baseline up to 30 days after the last dose of study treatment, assessed up to approximately 2.2 years

Part A1, A3, A4, A5 and B1: Number of Participants With Grade 3 or Higher Laboratory Findings According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0

Baseline up to 30 days after the last dose of study treatment, assessed up to approximately 2.2 years

Part A1, A3, A4, A5 and B1: Number of Participants With Abnormalities in Vital Signs

Baseline up to 30 days after the last dose of study treatment, assessed up to approximately 2.2 years

Part A1, A3, A4, A5 and B1: Number of Participants With Clinical Significant Abnormalities in Electrocardiogram (ECG) Findings

Baseline up to 30 days after the last dose of study treatment, assessed up to approximately 2.2 years

Part A2: Area Under the Plasma Concentration Curve From Time Zero to 24 Hours Post Dose (AUC 0-24h) of Tuvusertib (M1774)

Cycle 1 Day -7 and Day 1: Pre-dose up to 24 hours post-dose (Each Cycle is of 21 days)

Part A2: Area Under the Plasma Concentration Curve From Time Zero to Infinity Post Dose (AUC 0-inf) of Tuvusertib (M1774)

Cycle 1 Day -7 and Day 1: Pre-dose up to 24 hours post-dose (Each Cycle is of 21 days)

Part A2: Maximum Observed Plasma Concentration (Cmax) of Tuvusertib (M1774)

Cycle 1 Day -7 and Day 1: Pre-dose up to 24 hours post-dose (Each Cycle is of 21 days)

Part A2: Relative Bioavailability Based on Area Under the Plasma Concentration Curve (Frel[AUC]) of Tuvusertib (M1774) Under Fed Condition as Compared to Fasting Condition

Cycle 1 Day -7 and Day 1: Pre-dose up to 24 hours post-dose (Each Cycle is of 21 days)

Part A2: Relative Bioavailability Based on Maximum Observed Plasma Concentration (Frel[Cmax]) of Tuvusertib (M1774) Under Fed Condition as Compared to Fasting Condition

Cycle 1 Day -7 and Day 1: Pre-dose up to 24 hours post-dose (Each Cycle is of 21 days)

Part A3: Objective Response as Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

Baseline up to 2.2 years

Part B1: Occurrence of Dose-Limiting Toxicities (DLTs) During the DLT Observation Period

Day 1 to Day 28 of Cycle 1 (Each Cycle is of 28 days)

Part A1, A4, A5 and B1: To Determine the Recommended Dose Expansion (RDE) for Tuvusertib (M1774) monotherapy globally, in Japanese and in Chinese participants With Metastatic or Locally Advanced Unresectable Solid Tumors and in combination with Niraparib

Assessed up to approximately 2.2 years

Secondary Endpoints

Part A1, A3, A4 and A5: Maximum Observed Plasma Concentration (Cmax) of Tuvusertib (M1774)

Cycle 1 Day 1 and Day 8: Pre-dose up to 24 hours post-dose (Each Cycle is of 21 days)

Part A1, A3, A4 and A5: Time to Reach Maximum Plasma Concentration (tmax) of Tuvusertib (M1774)

Cycle 1 Day 1 and Day 8: Pre-dose up to 24 hours post-dose (Each Cycle is of 21 days)

Part A1, A3, A4 and A5: Area Under the Plasma Concentration Curve From Time Zero to 24 Hours Post Dose (AUC0-24h) of Tuvusertib (M1774)

Cycle 1 Day 1 and Day 8: Pre-dose up to 24 hours post-dose (Each Cycle is of 21 days)

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Study Design & Arms

AllocationNON_RANDOMIZED

MaskingNONE

ModelSEQUENTIAL

PurposeTREATMENT

Treatment Arms

Arm	Type	Description
Part A1: Monotherapy Dose Escalation	EXPERIMENTAL	Participants will initially receive Tuvusertib (M1774) once daily under fasting conditions. Additional schedules may be evaluated if needed.
Part A2 - Preliminary Food Effect Assessment	EXPERIMENTAL	Participants in the food effect assessment will receive Tuvusertib (M1774) at the dose and schedule determined as recommended dose for expansion (RDE) in Part A1. A single dose of Tuvusertib (M1774) will be administered on Day -7 under a fed (low-fat meal) or fasted condition, followed by a 1-week washout period. After completion of the scheduled food effect assessments, participants will follow the same schedule as participants in Part A1.
Part A3 - Monotherapy Expansion	EXPERIMENTAL	Part A3 is an expansion of Part A1 where Tuvusertib (M1774) will be administered as a single agent at the RDE established in Part A1. Participants with defined loss-of-function mutation in ARID1A, ATRX and/or DAXX, and ATM will be enrolled.
Part B1: Combination Therapy Dose Finding	EXPERIMENTAL	B1a: Participants with baseline body weight less than (\<) 77 kilogram (kg) or platelets \<150,000 cubic per millimeter (mm\^3) will receive Niraparib once daily combined with different doses of Tuvusertib (M1774). B1b: Participants with baseline body weight greater than or equal to (\>=) 77 kg and or platelets \>= 150,000 mm\^3 will receive Niraparib once daily combined with different doses of Tuvusertib (M1774) and schedule determined as recommended dose for expansion (RDE) in Part B1a.
Part A4: Japan Dose Confirmation Monotherapy	EXPERIMENTAL	Starting at global RDE from Part A1, in Japan. Participants will initially receive Tuvusertib (M1774) once daily under fasting conditions. Additional schedules may be evaluated if needed.
Part A5: China Dose Confirmation Monotherapy	EXPERIMENTAL	Starting at global RDE from Part A1, in China. Participants will initially receive Tuvusertib (M1774) once daily under fasting conditions. Additional schedules may be evaluated if needed.

Interventions

Name	Type	Description
M1774	DRUG	M1774 will be administered orally throughout the study.
Niraparib	DRUG	Niraparib will be administered orally throughout the study.

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Eligibility Criteria

Age Range18 Years — N/A

SexALL

Healthy VolunteersNo

Study Sites16

Inclusion Criteria: * Participants with locally advanced or metastatic disease that is refractory to standard therapy or for which no standard therapy is judged appropriate by the Investigator which may convey clinical benefit * Eastern Cooperative Oncology Group (ECOG) Performance Status less than...

Countries:United StatesChinaJapanSpainUnited Kingdom

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Recent Changes (Last 90 Days)

LOWMay 24, 2026NCT04170153studyFirstPostDate: changed