Berzosertib

Phase 2Small molecule

Berzosertib is one of 82 small molecule programs targeting Extensive Stage Lung Small Cell Carcinoma. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Extensive Stage Lung Small Cell CarcinomaActive, not recruiting

Metastatic Fallopian Tube CarcinomaActive, not recruiting

Bilateral Breast CarcinomaActive, not recruiting

Clinical Stage III Gastric Cancer AJCC V8Active, not recruiting

Castration-Resistant Prostate CarcinomaActive, not recruiting

Lung Non-Small Cell Squamous CarcinomaActive, not recruiting

Head and Neck Carcinoma of Unknown PrimaryActive, not recruiting

Metastatic Colorectal CarcinomaActive, not recruiting

Non-Small Cell Lung CancerActive, not recruiting

Unresectable Solid TumorActive, not recruiting

Extensive Stage Lung Small Cell CarcinomaPhase 2

Active, not recruiting

Metastatic Fallopian Tube CarcinomaPhase 1

Active, not recruiting

Bilateral Breast CarcinomaPhase 1

Active, not recruiting

Clinical Stage III Gastric Cancer AJCC V8Phase 2

Active, not recruiting

Castration-Resistant Prostate CarcinomaPhase 2

Active, not recruiting

Lung Non-Small Cell Squamous CarcinomaPreclinical

Active, not recruiting

Head and Neck Carcinoma of Unknown PrimaryPhase 1

Active, not recruiting

Metastatic Colorectal CarcinomaPhase 1

Active, not recruiting

Non-Small Cell Lung CancerPhase 1

Active, not recruiting

Unresectable Solid TumorPhase 2

Active, not recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

449 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Nano-Crystalline Megestrol Acetate

Changchun GeneScience Pharmaceutical Co., Ltd.

Phase 3

1 2

Anktiva

SSWOG Cancer Research Network

Phase 3

1 3

Carboplatin/paclitaxel

AstraZeneca

Phase 3

3 4

Berzosertib

Merck & Co.

Phase 2

1 5

Remeron

OOrganon and Co

Preclinical

1 6

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—7

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

1 9

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—10

Valemetostat Tosylate

Daiichi Sankyo

Preclinical

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

Timeline

Expected Milestones

Q1 2027

Phase 2Active, not recruiting

Clinical Stage III Gastric Cancer AJCC V8

NCT03641313

Phase 1Active, not recruiting

Bilateral Breast Carcinoma

NCT04052555

Phase 1Active, not recruiting

Metastatic Colorectal Carcinoma

NCT02595931

PreclinicalActive, not recruiting

Lung Non-Small Cell Squamous Carcinoma

NCT04216316

Q2 2027

Phase 2Active, not recruiting

Castration-Resistant Prostate Carcinoma

NCT03517969

Phase 2Active, not recruiting

Extensive Stage Lung Small Cell Carcinoma

NCT03896503

Clinical

Trials by Indication[1]

Unresectable Solid Tumor1 trial

Avelumab and M6620 for the Treatment of DDR Deficient Metastatic or Unresectable Solid Tumors

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT04266912·23 enrolled

Lung Cancer1 trial

Berzosertib + Topotecan in Relapsed Platinum-Resistant Small-Cell Lung Cancer (DDRiver SCLC 250)

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

EMD Serono Research & Development Institute, Inc.·Phase 2·NCT04768296·76 enrolled

Non-Small Cell Lung Cancer1 trial

Testing the Safety of M6620 (VX-970) When Given With Standard Whole Brain Radiation Therapy for the Treatment of Brain Metastases From Non-small Cell Lung Cancer, Small Cell Lung Cancer, or Neuroendocrine Tumors

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT02589522·15 enrolled

Metastatic Urothelial Cancer1 trial

Cisplatin and Gemcitabine Hydrochloride With or Without Berzosertib in Treating Patients With Metastatic Urothelial Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT02567409·87 enrolled

Solid Tumors1 trial

Berzosertib Human Mass Balance Study (DDRiver Solid Tumors 208)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT05246111·6 enrolled

12 more indications

Neuroendocrine Cancer1 trial

Lurbinectedin With Berzosertib, an ATR Kinase Inhibitor in Small Cell Cancers and High-Grade Neuroendocrine Cancers

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1/2·NCT04802174·37 enrolled

Ovarian Serous Tumor1 trial

Phase 2 Study of M6620 (VX-970) in Combination With Gemcitabine Versus Gemcitabine Alone in Subjects With Platinum-Resistant Recurrent Ovarian or Primary Peritoneal Fallopian Tube Cancer

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT02595892·70 enrolled

Metastatic Colorectal Carcinoma1 trial

Phase I Clinical Trial of M6620 (VX-970, Berzosertib) in Combination With the Topoisomerase I Inhibitor Irinotecan in Patients With Advanced Solid Tumors

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT02595931·66 enrolled

Head and Neck Carcinoma of Unknown Primary1 trial

A Phase I Study of M6620 (VX-970, Berzosertib) in Combination With Cisplatin and XRT in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC; SDC 10060121)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT02567422·43 enrolled

Bilateral Breast Carcinoma1 trial

A Phase 1b Study of Berzosertib in Combination With Radiation Therapy to Overcome Therapeutic Resistance in Chemotherapy Resistant Triple Negative and Estrogen and/or Progesterone Receptor Positive, HER2 Negative Breast Cancer

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT04052555·42 enrolled

Lung Non-Small Cell Squamous Carcinoma1 trial

A Phase IB and Randomized Open-Label Phase II Study of Berzosertib (M6620, VX-970) in Combination With Carboplatin/Gemcitabine/Pembrolizumab in Patients With Chemotherapy-Naïve Advanced Non-Small Cell Lung Cancer of Squamous Cell Histology

Active, not recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT04216316·12 enrolled

Castration-Resistant Prostate Carcinoma1 trial

A Phase 2 Study of M6620 (VX-970, Berzosertib) in Combination With Carboplatin Compared With Docetaxel in Combination With Carboplatin in Metastatic Castration-Resistant Prostate Cancer

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03517969·73 enrolled

Extensive Stage Lung Small Cell Carcinoma1 trial

Randomized Phase II Trial of Topotecan Plus M6620 (VX-970, Berzosertib) Vs. Topotecan Alone in Patients With Relapsed Small-Cell Lung Cancer

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03896503·104 enrolled

Metastatic Fallopian Tube Carcinoma1 trial

Phase 1 Dose Escalation and Expansion Cohort of Carboplatin and Gemcitabine With or Without M6620 (VX-970) in First or Second Recurrence Platinum-Sensitive Epithelial Ovarian, Peritoneal, and Fallopian Tube Cancer

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT02627443·35 enrolled

Clinical Stage III Gastric Cancer AJCC v81 trial

A Phase 2 Single-Arm Study of M6620 in Combination With Irinotecan in Patients With Progressive TP53 Mutant Gastric and Gastro-Esophageal Junction Cancer

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03641313·17 enrolled

HRD Cancer1 trial

A Phase I/II Study of Sacituzumab Govitecan Plus Berzosertib in Small Cell Lung Cancer, Extra-Pulmonary Small Cell Neuroendocrine Cancer and Homologous Recombination-Deficient Cancers Resistant to PARP Inhibitors

Completed·NNational Cancer Institute (NCI)·Preclinical·NCT04826341·35 enrolled

Unspecified1 trial

ATRi Transition Rollover Study

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT03309150·1 enrolled

Sources

References

[1]
ClinicalTrials.gov — 17 trial records for Berzosertib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Berzosertib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Berzosertib. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Merck & Co. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: Merck & Co.

Berzosertib

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2027

Trials by Indication[1]

Unresectable Solid Tumor1 trial

Lung Cancer1 trial

Non-Small Cell Lung Cancer1 trial

Metastatic Urothelial Cancer1 trial

Solid Tumors1 trial

Neuroendocrine Cancer1 trial

Ovarian Serous Tumor1 trial

Metastatic Colorectal Carcinoma1 trial

Head and Neck Carcinoma of Unknown Primary1 trial

Bilateral Breast Carcinoma1 trial

Lung Non-Small Cell Squamous Carcinoma1 trial

Castration-Resistant Prostate Carcinoma1 trial

Extensive Stage Lung Small Cell Carcinoma1 trial

Metastatic Fallopian Tube Carcinoma1 trial

Clinical Stage III Gastric Cancer AJCC v81 trial

HRD Cancer1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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