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Also known as M1774, Tuvusertib (M1774)
Tuvusertib · 4 trials · 3 indications
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 A, Arm 1: Tuvusertib with Niraparib | EXPERIMENTAL | In Part A, participants will be randomized to one of 2 arms to receive tuvusertib in combination with either niraparib or lartesertib. |
| Part A, Arm 2: Tuvusertib with Lartesertib | EXPERIMENTAL | In Part A, participants will be randomized to one of 2 arms to receive tuvusertib in combination with either niraparib or lartesertib. |
| Part B (dose optimization), dosing regimen 1 :Tuvusertib+Niraparib or Tuvusertib +Lartesertib | EXPERIMENTAL | In Part B, the most favorable combination treatment from Part A will be further explored at 2 different dosing regimens and compared to tuvusertib monotherapy. |
| Part B (dose optimization), dosing regimen 2: Tuvusertib + Niraparib or Tuvusertib + Lartesertib | EXPERIMENTAL | In Part B, the most favorable combination treatment from Part A will be further explored at 2 different dosing regimens and compared to tuvusertib monotherapy. |
| Part B: Tuvusertib Monotherapy | EXPERIMENTAL | In Part B, the most favorable combination treatment from Part A will be further explored at 2 different dosing regimens and compared to tuvusertib monotherapy. |
| Dosing Regimen 1 (Phase 1b): M1774 + Cemiplimab | EXPERIMENTAL | - |
| Dosing Regimen 2 (Phase 1b): M1774 + Cemiplimab | EXPERIMENTAL | - |
| Stratum A (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b | EXPERIMENTAL | - |
| Stratum B (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b | EXPERIMENTAL | - |
| Stratum C (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b | EXPERIMENTAL | - |
| 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 | - |
| 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 |
|---|---|---|
| Tuvusertib (M1774) | DRUG | Tuvusertib will be administered orally. |
| Niraparib | DRUG | Niraparib will be administered orally. If selected from Part A, Niraparib will be administered orally in combination with Tuvusertib. |
| Lartesertib (M4076) | DRUG | Lartesertib will be administered orally. If selected from Part A, Lartesertib will be administered orally in combination with Tuvusertib |
| M1774 | DRUG | In Phase 1b, M1774 will be administered as dosing regimen 1 or dosing regimen 2 until disease progression, death discontinuation criteria or any other reason. The selected dosing regimen of M1774 will be administered in all arms of Phase 2a. |
| Cemiplimab | DRUG | Cemiplimab will be administered as an intravenous infusion every 3 weeks in all arms of Phase 1b and Phase 2a until disease progression, death discontinuation criteria or any other reason. |
| 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: * Histologically or cytologically confirmed high grade serous or high grade endometrioid ovarian, primary peritoneal, and/or fallopian tube cancer that is recurrent. * Participants whose tumor carries germline or somatic deleterious or suspected deleterious mutations in the gene...
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Tuvusertib is an investigational small molecule being studied in oncology for metastatic or locally advanced unresectable solid tumors, non-small cell lung cancer, and ovarian cancer. It is being evaluated both as a single agent and in combination with other therapies in adult patients with these advanced cancers.
Tuvusertib is developed by Merck KGaA, which trades under the ticker MKGAF. The company is running the clinical development program for the drug across multiple solid tumor indications.
Tuvusertib is in Phase 1 clinical development, with additional Phase 2 evaluation ongoing. It is investigational and has not been approved by the FDA. The program includes both Phase 1 and Phase 2 studies that are currently active and not recruiting.
Tuvusertib is being studied in several trials, including NCT06433219 in epithelial ovarian cancer, NCT05882734 in non-squamous non-small cell lung cancer, NCT05396833 in advanced solid tumors, and NCT04170153 in metastatic or locally advanced unresectable solid tumors. All are active and not recruiting.
Yes, Tuvusertib is also known as M1774. The two names refer to the same investigational compound, and clinical trial listings and publications may use either designation when referring to this drug.
Yes, Tuvusertib trials are biomarker selected, meaning enrollment focuses on patients whose tumors have specific molecular characteristics relevant to the drug's mechanism. This approach is common in early-phase oncology studies evaluating targeted agents in genetically defined patient populations.