Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
M1774 · 1 trial · 1 indication
| 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. |
| Name | Type | Description |
|---|---|---|
| M1774 | DRUG | M1774 will be administered orally throughout the study. |
| Niraparib | DRUG | Niraparib will be administered orally throughout the study. |
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...
M1774, also known as tuvusertib, is an investigational small molecule being studied for the treatment of metastatic or locally advanced unresectable solid tumors. It is currently in Phase 1 clinical development for this oncology indication.
M1774 is a small molecule being developed for oncology. Its specific molecular target has not been disclosed in available information, so its mechanism of action is not detailed here.
M1774 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 1 clinical trials.
M1774 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. It is being studied in patients with metastatic or locally advanced unresectable solid tumors.
M1774 is being studied in a Phase 1 clinical trial with the identifier NCT04170153, titled "Tuvusertib (M1774) in Participants With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 301)." The trial is active but not recruiting, with an enrollment of 161 participants.
Yes, M1774 is also known as tuvusertib. The clinical trial NCT04170153 refers to the drug as tuvusertib (M1774), confirming that these names refer to the same investigational compound.