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Tuvusertib

Phase 2

Ovarian Cancer | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Jun 3, 2026

Target and mechanism

ModalitySmall molecule

Also known as Tuvusertib (M1774)

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment63

FDA Designations

No designations recorded

Clinical trial landscape

Tuvusertib · 1 trial · 1 indication

Phase 2 1
NCT06433219Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302)Ovarian Cancer
ACTIVE NOT_RECRUITING63 Analytics
PHASE2ACTIVE NOT_RECRUITING
Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302)
Ovarian CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Part A and Part B: Confirmed Objective Response (OR) According to RECIST v1.1 as Assessed by Investigator
Time from randomization to final assessment or until progressive disease, death, discontinuation criteria, approximately up to 3.5 years
Part A and Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs and Related TEAEs
Time from randomization to final assessment at end of safety follow-up visit, approximately up to 3.5 years

Secondary Endpoints

Part A and Part B: Duration of Response (DoR) According to RECIST 1.1 as Assessed by the Investigator
Time from randomization to final assessment or until progressive disease, death, discontinuation criteria, approximately up to 3.5 years
Part A and Part B: Progression Free Survival (PFS) According to RECIST 1.1 as Assessed by the Investigator
Time from randomization to final assessment or until progressive disease, death, discontinuation criteria, approximately up to 3.5 years
Part B: Overall Survival
Time from date of randomization to death, approximately 3.5 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A, Arm 1: Tuvusertib with NiraparibEXPERIMENTALIn 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 LartesertibEXPERIMENTALIn 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 +LartesertibEXPERIMENTALIn 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 + LartesertibEXPERIMENTALIn 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 MonotherapyEXPERIMENTALIn Part B, the most favorable combination treatment from Part A will be further explored at 2 different dosing regimens and compared to tuvusertib monotherapy.

Interventions

NameTypeDescription
Tuvusertib (M1774)DRUGTuvusertib will be administered orally.
NiraparibDRUGNiraparib will be administered orally. If selected from Part A, Niraparib will be administered orally in combination with Tuvusertib.
Lartesertib (M4076)DRUGLartesertib will be administered orally. If selected from Part A, Lartesertib will be administered orally in combination with Tuvusertib
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites84

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...

Countries:United StatesAustraliaBelgiumDenmarkFranceGermanyIsraelItalyNetherlandsPolandSpainSwitzerlandUnited Kingdom
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Competitive Landscape -Ovarian Cancer 176 trials

Top 20 of 59 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK5PHASE3Pembrolizumab, Paclitaxel, Bevacizumab, Docetaxel
AstraZeneca PLCAZN19PHASE3Olaparib
GSK plc Sponsored ADRGSK4PHASE3Niraparib
Eli Lilly and CompanyLLY8PHASE3Sofetabart Mipitecan, Paclitaxel, Topotecan, Gemcitabine, Pegylated liposomal doxorubicin
AbbVie, Inc.ABBV13PHASE3Mirvetuximab soravtansine plus Bevacizumab, Bevacizumab
Bristol-Myers Squibb CompanyBMY4PHASE3Rucaparib, Nivolumab
Genmab A/S Sponsored ADRGMAB5PHASE3Rina-S, Paclitaxel, Topotecan, Pegylated liposomal doxorubicin, Gemcitabine
Pfizer Inc.PFE4PHASE3Avelumab, Lorlatanib, Talazoparib, Pemetrexed, Axitinib
Corcept Therapeutics Incorporated.CORT2PHASE3Nab-paclitaxel/m^2, Relacorilant once daily
Verastem, Inc.VSTM4PHASE3avutometinib, Defactinib, Pegylated liposomal doxorubicin, Paclitaxel, Letrozole
Zentalis Pharmaceuticals, Inc.ZNTL3PHASE3Azenosertib
Imunon, Inc.IMNN3PHASE3IMNN-001, Paclitaxel, Carboplatin, Olaparib, Niraparib
Incyte CorporationINCY2PHASE3INCB123667
Genelux Corp.GNLX1PHASE3olvimulogene nanivacirepvec, Platinum chemotherapy: carboplatin or cisplatin, Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane or pegylated liposomal doxorubicin, Bevacizumab
Regeneron Pharmaceuticals, Inc.REGN4PHASE2Ubamatamab, Bevacizumab, Cemiplimab, Fianlimab, PLD
Novartis AG Sponsored ADRNVS4PHASE2Dabrafenib, Trametinib
BeOne Medicines Ltd. Sponsored ADRONC2PHASE3Pamiparib
IQVIA Holdings IncIQV1PHASE3Oregovomab, Paclitaxel, Carboplatin
Xencor, Inc.XNCR3PHASE2vudalimab
Exelixis, Inc.EXEL2PHASE2Cabozantinib
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Frequently asked questions about Tuvusertib

What is Tuvusertib used for?

Tuvusertib is an investigational small molecule being studied for the treatment of epithelial ovarian cancer. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

What does Tuvusertib target?

Tuvusertib is a small molecule being evaluated in combination with other agents for ovarian cancer. Its specific molecular target is not disclosed in the available information, so its mechanism of action is not described here.

Who makes Tuvusertib?

Tuvusertib is being developed by Merck & Company, Inc., a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol MRK.

What phase is Tuvusertib in?

Tuvusertib is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency for the treatment of ovarian cancer.

What clinical trials is Tuvusertib in?

Tuvusertib is being studied in a Phase 2 clinical trial with the identifier NCT06433219. The trial, titled 'Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302)', is active but not recruiting and has an enrollment of 63 participants.

Is Tuvusertib the same as M1774?

Yes, Tuvusertib is also known as M1774. Both names refer to the same investigational drug being developed by Merck & Company, Inc. for the treatment of ovarian cancer.