Berzosertib

Phase 2Small molecule

Merck & Co.

Berzosertib is one of 20 small molecule programs targeting Neuroendocrine Cancer. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Neuroendocrine CancerActive, not recruiting

Unresectable Solid TumorActive, not recruiting

Extensive Stage Lung Small Cell CarcinomaActive, not recruiting

Head and Neck Carcinoma of Unknown PrimaryActive, not recruiting

Metastatic Lung Neuroendocrine NeoplasmActive, not recruiting

Metastatic Fallopian Tube CarcinomaActive, not recruiting

Bilateral Breast CarcinomaActive, not recruiting

Lung Non-Small Cell Squamous CarcinomaActive, not recruiting

Neuroendocrine CancerPhase 2

Active, not recruiting

Unresectable Solid TumorPhase 2

Active, not recruiting

Extensive Stage Lung Small Cell CarcinomaPhase 2

Active, not recruiting

Head and Neck Carcinoma of Unknown PrimaryPhase 1

Active, not recruiting

Metastatic Lung Neuroendocrine NeoplasmPhase 1

Active, not recruiting

Metastatic Fallopian Tube CarcinomaPhase 1

Active, not recruiting

Bilateral Breast CarcinomaPhase 1

Active, not recruiting

Lung Non-Small Cell Squamous CarcinomaPreclinical

Active, not recruiting

Competition

Competitive Landscape

10 competitors in Neuroendocrine Cancer

#DrugCompanyPhaseTrials

Camptosar

Pfizer

Phase 2

1 2

Zepzelca

Jazz Pharmaceuticals

Phase 2

1 3

Tecentriq

Roche

Phase 2

1 4

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 2

2 5

Keytruda

Merck & Co.

Phase 1

1 6

Berzosertib

Merck & Co.

Phase 2

1 7

AK112

SSummit Therapeutics

Phase 2

1 8

Vepesid

AAvyxa

Phase 1

1 9

Taxotere

AAvyxa

Phase 1

1 10

Paraplatin

AAvyxa

Phase 1

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

Timeline

Expected Milestones

Q1 2027

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

Phase 1Active, not recruiting

Head and Neck Carcinoma of Unknown Primary

NCT02567422

Clinical

Trials by Indication[1]

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

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

Solid Tumors1 trial

Berzosertib Human Mass Balance Study (DDRiver Solid Tumors 208)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT05246111·6 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

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

12 more indications

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

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT03641313·17 enrolled

Metastatic Lung Neuroendocrine Neoplasm1 trial

Phase 1 Trial to Determine the Recommended Phase 2 Dose (RP2D) of M6620 (VX-970, Berzosertib) When Combined With Whole Brain Radiotherapy (WBRT) in Patients With Brain Metastases From Lung Cancer

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

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

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

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

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

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

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]

Metastatic Urothelial Cancer1 trial

Unresectable Solid Tumor1 trial

Solid Tumors1 trial

Lung Cancer1 trial

Neuroendocrine Cancer1 trial

Clinical Stage III Gastric Cancer AJCC v81 trial

Metastatic Lung Neuroendocrine Neoplasm1 trial

Castration-Resistant Prostate Carcinoma1 trial

Metastatic Colorectal Carcinoma1 trial

Lung Non-Small Cell Squamous Carcinoma1 trial

Ovarian Serous Tumor1 trial

Head and Neck Carcinoma of Unknown Primary1 trial

Bilateral Breast Carcinoma1 trial

Extensive Stage Lung Small Cell Carcinoma1 trial

Metastatic Fallopian Tube Carcinoma1 trial

HRD Cancer1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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