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Tuvusertib

Phase 2Small molecule

EMD Serono Research & Development Institute, Inc.

Tuvusertib is one of 100 small molecule programs targeting Astrocytoma. It is currently in Phase 2.

5

Indications

11

Total Trials

8

Active Trials

99

Competitors

Pipeline

Status by Indication[3][1]

Indication

AstrocytomaRecruiting

Solid TumorsActive, not recruiting

Advanced Malignant Solid NeoplasmRecruiting

Castration-Resistant Prostate CarcinomaActive, not recruiting

Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC V8Active, not recruiting

AstrocytomaPhase 2

Recruiting

Solid TumorsPhase 1

Active, not recruiting

Advanced Malignant Solid NeoplasmPhase 1

Recruiting

Castration-Resistant Prostate CarcinomaPhase 2

Active, not recruiting

Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC V8Phase 2

Active, not recruiting

Competition

Competitive Landscape

124 competitors in Solid Tumors

#DrugCompanyPhaseTrials

Keytruda

Lynparza

Lenvima

Taxol

Opdivo

Bristol-Myers Squibb

Imfinzi

Herceptin

Beyfortus

Yervoy

Bristol-Myers Squibb

Camptosar

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2Active, not recruiting

Castration-Resistant Prostate Carcinoma

NCT05828082

Phase 1Active, not recruiting

Solid Tumor

NCT06421935

PreclinicalRecruiting

Advanced Malignant Solid Neoplasm

NCT05691491

Q2 2027

Phase 1Recruiting

Recurrent Endometrial Carcinoma

NCT05950464

Q3 2027

Phase 1Recruiting

Advanced Malignant Solid Neoplasm

NCT05687136

Q1 2028

Phase 2Active, not recruiting

Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC V8

NCT05947500

Clinical

Trials by Indication[1]

Advanced Malignant Solid Neoplasm2 trials

A Molecularly Driven Phase 1b Dose Escalation and Dose Expansion Study of the DNA-PK Inhibitor Peposertib (M3814) in Combination With the ATR Inhibitor Tuvusertib (M1774)

Recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT05687136·66 enrolled

A Phase 1/2 Trial Evaluating the Combination of Temozolomide and the Ataxia Telangiectasia and Rad3-Related Inhibitor M1774

Recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT05691491·42 enrolled

Astrocytoma1 trial

Tuvusertib in Astrocytoma With ATRX Mutation

Recruiting·GGrupo Español de Investigación en Neurooncología·Phase 2·NCT07417761·56 enrolled

Advanced Urothelial Cancer1 trial

Study of Avelumab and Tuvusertib in Participants With Advanced Urothelial Cancer That Has Progressed on Prior Anti-PD-(L)1 Therapy (JAVELIN DDRiver Bladder)

Withdrawn· EMD Serono Research & Development Institute, Inc. logo

EMD Serono Research & Development Institute, Inc.·Phase 2·NCT06424717

Solid Tumors1 trial

Tuvusertib (M1774) Human Mass Balance and Absolute Bioavailability Study (DDRIVER Solid Tumors 303)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 1·NCT06308263·12 enrolled

Recurrent Endometrial Carcinoma1 trial

A Phase 1B Study of Combination ATR (M1774) and BET Inhibition (ZEN003694) to Exploit ARID1A Loss in Recurrent Ovarian and Endometrial Cancer

Recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT05950464·65 enrolled

5 more indications

Ovarian Cancer1 trial

An Open-label, Multicenter, Randomized Phase 2 Study of the ATR Inhibitor Tuvusertib in Combination With the PARP Inhibitor Niraparib or the ATM Inhibitor Lartesertib in Participants With BRCA Mutant and/or Homologous Recombination deﬁciency (HRD)-Positive Epithelial Ovarian Cancer That Progressed on Prior PARP Inhibitor Therapy (DDRiver EOC 302)

Completed· EMD Serono Research & Development Institute, Inc. logo

EMD Serono Research & Development Institute, Inc.·Phase 2·NCT06433219·63 enrolled

Metastatic or Locally Advanced Unresectable Solid Tumors1 trial

An Open-label, Multicenter Phase Ib Study of the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of the ATR Inhibitor Tuvusertib (M1774) in Combination With DNA Damage Response Inhibitors or Immune Checkpoint Inhibitors in Patients With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 320)

Completed· EMD Serono Research & Development Institute, Inc. logo

EMD Serono Research & Development Institute, Inc.·Phase 1·NCT05396833·120 enrolled

Solid Tumor1 trial

An Open Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of the PARP1 Inhibitor M9466 Alone or in Combination in Participants With Advanced Solid Tumors

Active, not recruiting· EMD Serono Research & Development Institute, Inc. logo

EMD Serono Research & Development Institute, Inc.·Phase 1·NCT06421935·60 enrolled

Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v81 trial

A Randomized Phase 2 Study of ATR Inhibition in Advanced PD-(L)1-Refractory Merkel Cell Carcinoma: The MATRiX Trial

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05947500·50 enrolled

Castration-Resistant Prostate Carcinoma1 trial

A Phase 2 Study of M1774 in Refractory SPOP-Mutant Prostate Cancer

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05828082·20 enrolled

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for Tuvusertib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Tuvusertib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Tuvusertib. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — EMD Serono Research & Development Institute, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: EMD Serono Research & Development Institute, Inc.

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