Berzosertib

Generic Name: Berzosertib

Drug Type: Small Molecule

Chemical Formula: C_₂₄H_₂₅N_₅O_₃S

CAS Number: 1232416-25-9

Unique Ingredient Identifier: L423PRV3V3

Background: Berzosertib (VX-970) has been used in trials studying the treatment of Ovarian Neoplasms, Ovarian Serous Tumor, Adult Solid Neoplasm, Advanced Solid Tumor, and Advanced Solid Neoplasm, among others.

Clinical Trials

Berzosertib Human Mass Balance Study (DDRiver Solid Tumors 208)

Phase 1

Completed

Conditions: Advanced Solid Tumor

Interventions: Drug: [14C]Berzosertib
Drug: Berzosertib
Drug: Topotecan

First Posted Date: 2022-02-18

Last Posted Date: 2024-11-22

Lead Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Target Recruit Count: 6

Registration Number: NCT05246111

Locations: 🇭🇺
Magyar Honvédség Egészségügyi Központ, Podmaniczky utcai telephely, Onkológiai Osztály, Budapest, Hungary
🇭🇺
PRA Magyarország Kft. Fázis I-es Klinikai Farmakológiai Vizsgálóhely, Budapest, Hungary

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

Phase 1

Recruiting

Conditions: HRD Cancer
SCLC
Advanced Solid Tumors

Interventions: Drug: Berzosertib
Drug: Sacituzumab Govitecan

First Posted Date: 2021-04-01

Last Posted Date: 2025-05-20

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 120

Registration Number: NCT04826341

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

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

Phase 1

Recruiting

Conditions: SCLC
Advanced Solid Tumor
High Grade Neuroendocrine Cancers
Small Cell Cancer

Interventions: Drug: Lurbinectedin
Drug: Berzosertib

First Posted Date: 2021-03-17

Last Posted Date: 2025-02-21

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 120

Registration Number: NCT04802174

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

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

Phase 2

Completed

Conditions: Small-cell Lung Cancer

Interventions: Drug: Berzosertib
Drug: Topotecan

First Posted Date: 2021-02-24

Last Posted Date: 2023-08-15

Lead Sponsor: EMD Serono Research & Development Institute, Inc.

Target Recruit Count: 76

Registration Number: NCT04768296

Locations: 🇺🇸
National Cancer Institute, Bethesda, Maryland, United States
🇺🇸
FirstHealth of the Carolinas, Inc., Pinehurst, North Carolina, United States
🇺🇸
Summa Health, Akron, Ohio, United States

and more 48 locations

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

Phase 1

Active, not recruiting

Conditions: Metastatic Malignant Solid Neoplasm
Refractory Malignant Solid Neoplasm
Unresectable Malignant Solid Neoplasm

Interventions: Drug: Avelumab
Drug: Berzosertib

First Posted Date: 2020-02-12

Last Posted Date: 2025-02-18

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 25

Registration Number: NCT04266912

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Testing the Addition of an Anti-cancer Drug, Berzosertib (M6620, VX-970), to the Usual Treatments (Carboplatin and Gemcitabine) and to Pembrolizumab for Patients With Advanced Squamous Cell Non-small Cell Lung Cancer

Phase 1

Active, not recruiting

Conditions: Lung Non-Small Cell Squamous Carcinoma
Stage IV Lung Cancer AJCC v8

Interventions: Drug: Berzosertib
Procedure: Biospecimen Collection
Drug: Carboplatin
Procedure: Computed Tomography
Drug: Gemcitabine Hydrochloride
Procedure: Magnetic Resonance Imaging
Biological: Pembrolizumab

First Posted Date: 2020-01-02

Last Posted Date: 2024-07-03

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 12

Registration Number: NCT04216316

Locations: 🇺🇸
UM Sylvester Comprehensive Cancer Center at Aventura, Aventura, Florida, United States
🇺🇸
Los Angeles General Medical Center, Los Angeles, California, United States
🇺🇸
USC Norris Oncology/Hematology-Newport Beach, Newport Beach, California, United States

and more 31 locations

Testing the Addition of an Anti-cancer Drug, Berzosertib, to the Usual Treatment (Radiation Therapy) for Chemotherapy-Resistant Triple-Negative and Estrogen and/or Progesterone Receptor Positive, HER2 Negative Breast Cancer

Phase 1

Active, not recruiting

Conditions: Localized Breast Carcinoma
Recurrent Breast Carcinoma
Triple-Negative Breast Carcinoma
Bilateral Breast Carcinoma
HER2-Negative Breast Carcinoma

Interventions: Drug: Berzosertib
Procedure: Biospecimen Collection
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Radiation: Radiation Therapy

First Posted Date: 2019-08-12

Last Posted Date: 2025-03-12

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 42

Registration Number: NCT04052555

Locations: 🇺🇸
University of Texas Medical Branch, Galveston, Texas, United States
🇺🇸
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
🇺🇸
Farmington Health Center, Farmington, Utah, United States

and more 11 locations

Randomized Trial of Topotecan With M6620, an ATR Kinase Inhibitor, in Small Cell Lung Cancers and Small Cell Cancers Outside of the Lungs

Phase 2

Active, not recruiting

Conditions: Limited Stage Lung Small Cell Carcinoma
Platinum-Resistant Lung Small Cell Carcinoma
Platinum-Sensitive Lung Small Cell Carcinoma
Extensive Stage Lung Small Cell Carcinoma
Extrapulmonary Small Cell Neuroendocrine Carcinoma
Recurrent Lung Small Cell Carcinoma

Interventions: Procedure: Biopsy Procedure
Drug: Berzosertib
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Drug: Topotecan Hydrochloride

First Posted Date: 2019-04-01

Last Posted Date: 2025-04-20

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 104

Registration Number: NCT03896503

Locations: 🇺🇸
Los Angeles General Medical Center, Los Angeles, California, United States
🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
USC Norris Oncology/Hematology-Newport Beach, Newport Beach, California, United States

and more 30 locations

M6620 (VX-970) in Selected Solid Tumors

Phase 2

Completed

Conditions: Solid Tumor
Osteosarcoma
Leiomyosarcoma

Interventions: Drug: M6620

First Posted Date: 2018-10-24

Last Posted Date: 2023-07-07

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 30

Registration Number: NCT03718091

Locations: 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
🇺🇸
Boston Children Hospital, Boston, Massachusetts, United States

and more 1 locations

Phase Ib/II Study of Carboplatin + M6620 + Avelumab in PARPi-resistant Ovarian Cancer

Phase 1

Completed

Conditions: Ovarian Cancer

Interventions: Drug: M6620
Drug: Avelumab
Drug: Carboplatin

First Posted Date: 2018-10-12

Last Posted Date: 2020-11-13

Lead Sponsor: EMD Serono Research & Development Institute, Inc.

Target Recruit Count: 3

Registration Number: NCT03704467

Locations: 🇺🇸
The Stamford Hospital, Stamford, Connecticut, United States
🇺🇸
Marin Cancer Care, Inc., Greenbrae, California, United States
🇺🇸
Covenant Health Care, Saginaw, Michigan, United States

and more 9 locations

Drug Development Updates

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