Approval Probability
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Tuvusertib · 1 trial · 1 indication
The PD biomarker of histone variant will be measured by flow cytometry.
The PD biomarker of histone variant will be measured by flow cytometry.
| Arm | Type | Description |
|---|---|---|
| Part A1: Tuvusertib and Lartesertib | EXPERIMENTAL | - |
| Part A1.1: Tuvusertib and Lartesertib | EXPERIMENTAL | Assessment of the Effect of Food (Low-fat Meal) on the PK of M4076 Monotherapy Followed by Treatment with M1774 in Combination with M4076 |
| Part A1.2: Tuvusertib and Lartesertib | EXPERIMENTAL | Relative Bioavailability Assessment of Tuvusertib Tablet (TF1) vs Capsule Followed by Treatment with Tuvusertib in Combination with Lartesertib |
| Part A2: Tuvusertib and Lartesertib | EXPERIMENTAL | ATM in prostate cancer (Part A2) |
| Part A3: Tuvusertib and Lartesertib | EXPERIMENTAL | ARID1A in endometrial cancer |
| Part A2/A3: Tuvusertib and Lartesertib | EXPERIMENTAL | Tablet formulation (TF1, test) compared to a capsule formulation (reference) |
| Part B1: Tuvusertib and Avelumab | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Tuvusertib | DRUG | Tuvusertib will be administered orally once daily over a defined period of time in Part A1, A1.1, A1.2, A2, A3, A2/A3, and Part B1 until disease progression, death, discontinuation, or end of study. |
| Lartesertib | DRUG | Lartesertib will be administered orally once daily over a defined period of time in Part A1, A1.1, A1.2, A2, A3, A2/A3, until disease progression, death, discontinuation, or end of study. |
| Avelumab | DRUG | Avelumab will be administered by intravenous infusion once a day over a defined period of time in Part B1 until disease progression, death, discontinuation, or end of study. |
Inclusion Criteria: * Parts A1, A1.1, A1.2, A2, A3, and A2/3: Participants with metastatic or locally advanced unresectable solid tumors refractory to standard therapy or for which no standard therapy is judged appropriate by the Investigator, which may convey clinical benefit, or who cannot tolera...
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 and has not been approved by regulatory authorities.
Tuvusertib is being developed by Merck KGaA, a pharmaceutical company traded under the ticker MKGAF. The drug is in Phase 1 clinical trials for oncology indications.
Tuvusertib is in Phase 1 clinical development. It is an investigational drug being studied in a single active clinical trial for metastatic or locally advanced unresectable solid tumors, and it has not yet been approved.
Tuvusertib is being evaluated in clinical trial NCT05396833, titled 'Study of Tuvusertib (M1774) in Combination With DNA Damage Response Inhibitor or Immune Checkpoint Inhibitor (DDRiver Solid Tumors 320)'. This Phase 1 trial is active but not recruiting, with an enrollment of 120 participants.
Yes, Tuvusertib is also known as M1774. The clinical trial NCT05396833 refers to the drug as Tuvusertib (M1774), confirming that both names identify the same investigational compound.
The Tuvusertib clinical trial NCT05396833 is being conducted in multiple countries, including the United States, Australia, Canada, South Korea, and Spain. The trial enrolls adults aged 18 years and older with metastatic or locally advanced unresectable solid tumors.