Tuvusertib

Phase 2Small molecule

EMD Serono Research & Development Institute, Inc.

Tuvusertib is one of 177 small molecule programs targeting Astrocytoma. It is currently in Phase 2.

Indications

Total Trials

Active Trials

176

Competitors

Pipeline

Status by Indication[3][1]

Indication

AstrocytomaActive, not recruiting

Merkel Cell Skin CancerActive, not recruiting

Prostate CancerActive, not recruiting

Ovarian CancerActive, not recruiting

Endometrial CancerActive, not recruiting

Solid TumorActive, not recruiting

Advanced Solid TumorActive, not recruiting

Recurrent Endometrial CarcinomaRecruiting

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

AstrocytomaPhase 2

Active, not recruiting

Merkel Cell Skin CancerPhase 2

Active, not recruiting

Prostate CancerPhase 2

Active, not recruiting

Ovarian CancerPhase 2

Active, not recruiting

Endometrial CancerPhase 1

Active, not recruiting

Solid TumorPhase 1

Active, not recruiting

Advanced Solid TumorPhase 1

Active, not recruiting

Recurrent Endometrial CarcinomaPhase 1

Recruiting

Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC V8Phase 2

Active, not recruiting

Competition

Competitive Landscape

1399 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Tuvusertib

EMD Serono Research & Development Institute, Inc.

Phase 2

1 2

Novantrone

Pfizer

Preclinical

5 3

Mekinist

Novartis

Preclinical

3 4

Trexall

Alnylam Pharmaceuticals

Preclinical

—5

Jatenzo

GGrupo Espanol de Tumores Neuroendocrinos

Preclinical

2 6

Ranexa

MMenarini International Operations Luxembourg SA

Preclinical

1 7

Duragesic

CCephalon

Preclinical

1 8

Prednisone/prednisolone

Roche

Preclinical

3 9

Triptorelin Pamoate

Ipsen

Preclinical

2 10

Therapeutic Hydrocortisone

EEastern Cooperative Oncology Group

Preclinical

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

Timeline

Expected Milestones

Q3 2026

Phase 1Recruiting

Advanced Solid Tumors

NCT05687136

Q1 2027

Phase 1Active, not recruiting

Solid Tumor

NCT06421935

Phase 1/2Recruiting

Effectiveness

NCT05691491

Q2 2027

Phase 1Recruiting

Recurrent Endometrial Carcinoma

NCT05950464

Q1 2028

Phase 2Active, not recruiting

Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC V8

NCT05947500

Clinical

Trials by Indication[1]

Prostate Cancer1 trial

Testing the Effect of M1774 on Hard-to-Treat Refractory SPOP-mutant Prostate Cancer

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

Advanced Solid Tumors1 trial

Testing the Combination of Two Anti-cancer Drugs, Peposertib (M3814) and Tuvusertib (M1774) for Advanced Solid Tumors

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

Astrocytoma1 trial

Tuvusertib in Astrocytoma With ATRX Mutation

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

Effectiveness1 trial

Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety and Effectiveness

Recruiting·NNational Cancer Institute (NCI)·Phase 1/2·NCT05691491·58 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

6 more indications

Ovarian Cancer1 trial

Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302)

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

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

Immune Checkpoint Inhibitor1 trial

Study of Tuvusertib (M1774) in Combination With DNA Damage Response Inhibitor or Immune Checkpoint Inhibitor (DDRiver Solid Tumors 320)

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

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

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

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

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

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

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.

Tuvusertib

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q1 2027

Q2 2027

Q1 2028

Trials by Indication[1]

Prostate Cancer1 trial

Advanced Solid Tumors1 trial

Astrocytoma1 trial

Effectiveness1 trial

Advanced Urothelial Cancer1 trial

Ovarian Cancer1 trial

Immune Checkpoint Inhibitor1 trial

Solid Tumors1 trial

Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v81 trial

Recurrent Endometrial Carcinoma1 trial

Solid Tumor1 trial

References

Drug Info

Quick Facts

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