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

M6620 Plus Standard Treatment in Oesophageal and Other Cancer

Phase 1

Completed

Conditions: Oesophageal Adenocarcinoma
Squamous Cell Carcinoma
Solid Tumor

Interventions: Drug: M6620
Drug: Cisplatin
Drug: Capecitabine
Radiation: Radiotherapy

First Posted Date: 2018-08-22

Last Posted Date: 2024-07-18

Lead Sponsor: University of Oxford

Target Recruit Count: 36

Registration Number: NCT03641547

Locations: 🇬🇧
St James's University Hospital, Leeds, United Kingdom
🇬🇧
The Christie, Manchester, United Kingdom
🇬🇧
Velindre Cancer Centre, Cardiff, United Kingdom

and more 2 locations

Berzosertib and Irinotecan in Treating Patients With Progressive, Metastatic, or Unresectable TP53 Mutant Gastric or Gastroesophageal Junction Cancer

Phase 2

Active, not recruiting

Conditions: Metastatic Gastroesophageal Junction Adenocarcinoma
Clinical Stage III Gastric Cancer AJCC v8
Clinical Stage IV Gastric Cancer AJCC v8
Unresectable Gastroesophageal Junction Adenocarcinoma
Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
Metastatic Gastric Adenocarcinoma
Unresectable Gastric Adenocarcinoma

Interventions: Drug: Berzosertib
Procedure: Computed Tomography Assisted Biopsy
Procedure: Endoscopic Biopsy
Drug: Irinotecan
Procedure: Magnetic Resonance Imaging

First Posted Date: 2018-08-22

Last Posted Date: 2024-12-27

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 14

Registration Number: NCT03641313

Locations: 🇺🇸
The University of Kansas Cancer Center - Olathe, Olathe, Kansas, United States
🇺🇸
City of Hope Comprehensive Cancer Center, Duarte, California, United States
🇺🇸
Los Angeles General Medical Center, Los Angeles, California, United States

and more 28 locations

M6620 and Carboplatin With or Without Docetaxel in Treating Patients With Metastatic Castration-Resistant Prostate Cancer

Phase 2

Active, not recruiting

Conditions: Stage IV Prostate Cancer AJCC v8
Metastatic Prostate Carcinoma
Castration-Resistant Prostate Carcinoma

Interventions: Drug: Berzosertib
Drug: Carboplatin
Drug: Docetaxel
Other: Laboratory Biomarker Analysis

First Posted Date: 2018-05-08

Last Posted Date: 2025-05-09

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 73

Registration Number: NCT03517969

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
🇺🇸
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States

and more 20 locations

ATRi Transition Rollover Study

Phase 1

Completed

Conditions: Advanced Stage Solid Tumors

Interventions: Drug: Berzosertib

First Posted Date: 2017-10-13

Last Posted Date: 2024-11-28

Lead Sponsor: Merck KGaA, Darmstadt, Germany

Target Recruit Count: 1

Registration Number: NCT03309150

Locations: 🇬🇧
Royal Marsden NHS Foundation Trust, Sutton, United Kingdom

Carboplatin, Gemcitabine Hydrochloride, and Berzosertib in Treating Patients With Recurrent and Metastatic Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Phase 1

Active, not recruiting

Conditions: Metastatic Ovarian Carcinoma
Platinum-Sensitive Ovarian Carcinoma
Recurrent Ovarian Carcinoma
Stage IV Fallopian Tube Cancer AJCC v6 and v7
Stage IV Ovarian Cancer AJCC v6 and v7
Stage IV Primary Peritoneal Cancer AJCC v7
Ovarian Endometrioid Tumor
Recurrent Primary Peritoneal Carcinoma
Metastatic Primary Peritoneal Carcinoma
Recurrent Fallopian Tube Carcinoma

Interventions: Drug: Berzosertib
Drug: Carboplatin
Drug: Gemcitabine Hydrochloride
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study

First Posted Date: 2015-12-11

Last Posted Date: 2025-03-07

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 31

Registration Number: NCT02627443

Locations: 🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
🇺🇸
Mayo Clinic in Florida, Jacksonville, Florida, United States
🇺🇸
University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States

and more 11 locations

Gemcitabine Hydrochloride Alone or With M6620 in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Phase 2

Active, not recruiting

Conditions: Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Ovarian Serous Tumor
Recurrent Primary Peritoneal Carcinoma

Interventions: Drug: Berzosertib
Drug: Gemcitabine
Drug: Gemcitabine Hydrochloride

First Posted Date: 2015-11-04

Last Posted Date: 2025-02-07

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 70

Registration Number: NCT02595892

Locations: 🇺🇸
UC San Diego Moores Cancer Center, La Jolla, California, United States
🇺🇸
Mayo Clinic in Florida, Jacksonville, Florida, United States
🇺🇸
University of Virginia Cancer Center, Charlottesville, Virginia, United States

and more 14 locations

M6620 and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery

Phase 1

Active, not recruiting

Conditions: Metastatic Pancreatic Carcinoma
Refractory Pancreatic Carcinoma
Stage IV Pancreatic Cancer AJCC v8
Refractory Colorectal Carcinoma
Metastatic Lung Small Cell Carcinoma
Stage III Pancreatic Cancer AJCC v8
Stage IV Colorectal Cancer AJCC v8
Stage IV Lung Cancer AJCC v8
Unresectable Colorectal Carcinoma
Unresectable Lung Small Cell Carcinoma

Interventions: Drug: Berzosertib
Procedure: Biopsy Specimen
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Drug: Irinotecan Hydrochloride

First Posted Date: 2015-11-04

Last Posted Date: 2025-03-26

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 66

Registration Number: NCT02595931

Locations: 🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
Los Angeles General Medical Center, Los Angeles, California, United States
🇺🇸
Stanford Cancer Institute Palo Alto, Palo Alto, California, United States

and more 20 locations

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

Phase 1

Active, not recruiting

Conditions: Metastatic Lung Non-Small Cell Carcinoma
Metastatic Lung Small Cell Carcinoma
Metastatic Lung Neuroendocrine Neoplasm
Stage IVB Lung Cancer AJCC v8
Metastatic Malignant Neoplasm in the Brain
Stage IVA Lung Cancer AJCC v8
Stage IV Lung Cancer AJCC v8

Interventions: Drug: Berzosertib
Other: Quality-of-Life Assessment
Procedure: Therapeutic Conventional Surgery
Radiation: Whole-Brain Radiotherapy

First Posted Date: 2015-10-28

Last Posted Date: 2025-03-21

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 15

Registration Number: NCT02589522

Locations: 🇺🇸
Mayo Clinic in Florida, Jacksonville, Florida, United States
🇺🇸
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
🇺🇸
University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, United States

and more 6 locations

Testing the Addition of M6620 (VX-970, Berzosertib) to Usual Chemotherapy and Radiation for Head and Neck Cancer

Phase 1

Active, not recruiting

Conditions: Head and Neck Carcinoma of Unknown Primary
Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7
Head and Neck Squamous Cell Carcinoma
Stage III Hypopharyngeal Squamous Cell Carcinoma AJCC v7
Stage III Laryngeal Squamous Cell Carcinoma AJCC v6 and v7
Stage III Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
Stage III Sinonasal Squamous Cell Carcinoma AJCC v6 and v7
Stage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7
Stage IV Laryngeal Squamous Cell Carcinoma AJCC v7
Stage IV Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7

Interventions: Drug: Berzosertib
Drug: Cisplatin
Procedure: Computed Tomography
Other: Laboratory Biomarker Analysis
Procedure: Magnetic Resonance Imaging
Procedure: Positron Emission Tomography
Radiation: Radiation Therapy

First Posted Date: 2015-10-05

Last Posted Date: 2024-05-17

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 43

Registration Number: NCT02567422

Locations: 🇺🇸
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
🇺🇸
City of Hope Comprehensive Cancer Center, Duarte, California, United States
🇺🇸
University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States

and more 16 locations

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

Phase 2

Completed

Conditions: Stage IV Bladder Urothelial Carcinoma AJCC v7
Metastatic Renal Pelvis and Ureter Urothelial Carcinoma
Metastatic Bladder Urothelial Carcinoma
Metastatic Ureter Urothelial Carcinoma

Interventions: Drug: Berzosertib
Drug: Cisplatin
Drug: Gemcitabine Hydrochloride

First Posted Date: 2015-10-05

Last Posted Date: 2025-03-03

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 87

Registration Number: NCT02567409

Locations: 🇺🇸
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States
🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States

and more 36 locations

Drug Development Updates

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