Multiple early- to mid-stage clinical trials—including Phase 1, combined Phase 1/2, and Phase 2 studies—are evaluating Berzosertib (VE-822), frequently in combination with standard chemotherapeutic agents. Sponsored by government agencies, pharmaceutical companies, and academic research institutes, these studies target advanced solid tumors alongside specific malignancies such as small-cell lung cancer, non-small cell lung carcinoma, metastatic urothelial carcinoma, castration-resistant prostate cancer, and adult leiomyosarcoma. Recruitment across these investigations is primarily completed or active but not recruiting.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT04052555 | ACTIVE_NOT_RECRUITING | Bilateral Breast Carcinoma; HER2-Negative Breast Carcinoma; Localized Breast Carcinoma; Recurrent Breast Carcinoma; Triple-Negative Breast Carcinoma |
National Cancer Institute (NCI) |
2020-09-24 | PHASE1 |
| NCT04826341 | COMPLETED | HRD Cancer; SCLC; Advanced Solid Tumors |
National Cancer Institute (NCI) |
2021-09-20 | PHASE1; PHASE2 |
| NCT04802174 | ACTIVE_NOT_RECRUITING | SCLC; Small Cell Cancer; Advanced Solid Tumor; High Grade Neuroendocrine Cancers |
National Cancer Institute (NCI) |
2021-06-01 | PHASE1; PHASE2 |
| NCT04266912 | ACTIVE_NOT_RECRUITING | Metastatic Malignant Solid Neoplasm; Refractory Malignant Solid Neoplasm; Unresectable Malignant Solid Neoplasm |
M.D. Anderson Cancer Center |
2020-03-17 | PHASE1; PHASE2 |
| NCT02627443 | ACTIVE_NOT_RECRUITING | Metastatic Fallopian Tube Carcinoma; Metastatic Ovarian Carcinoma; Metastatic Primary Peritoneal Carcinoma; Ovarian Endometrioid Tumor; Ovarian High Grade Serous Adenocarcinoma; Platinum-Sensitive Ovarian Carcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal 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 |
National Cancer Institute (NCI) |
2017-05-16 | PHASE1 |
| NCT04807816 | COMPLETED | Leiomyosarcoma, Adult |
Institut Bergonié |
2022-02-09 | PHASE2 |
| NCT03641313 | ACTIVE_NOT_RECRUITING | Clinical Stage III Gastric Cancer AJCC v8; Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage IV Gastric Cancer AJCC v8; Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8; Metastatic Gastric Adenocarcinoma; Metastatic Gastroesophageal Junction Adenocarcinoma; Unresectable Gastric Adenocarcinoma; Unresectable Gastroesophageal Junction Adenocarcinoma |
National Cancer Institute (NCI) |
2020-11-16 | PHASE2 |
| NCT04216316 | ACTIVE_NOT_RECRUITING | Lung Non-Small Cell Squamous Carcinoma; Stage IV Lung Cancer AJCC v8 |
National Cancer Institute (NCI) |
2021-04-14 | PHASE1; PHASE2 |
| NCT03309150 | COMPLETED | Advanced Stage Solid Tumors |
Merck KGaA, Darmstadt, Germany |
2018-01-10 | PHASE1 |
| NCT02567422 | ACTIVE_NOT_RECRUITING | Head and Neck Carcinoma of Unknown Primary; 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 Oropharyngeal Squamous Cell Carcinoma AJCC 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; Stage IV Oropharyngeal Squamous Cell Carcinoma AJCC v7; Stage IV Sinonasal Squamous Cell Carcinoma AJCC v7 |
National Cancer Institute (NCI) |
2017-04-17 | PHASE1 |
| NCT04768296 | COMPLETED | Small-cell Lung Cancer |
EMD Serono Research & Development Institute, Inc. |
2021-03-29 | PHASE2 |
| NCT05246111 | COMPLETED | Advanced Solid Tumor |
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany |
2022-02-15 | PHASE1 |
| NCT02567409 | COMPLETED | Metastatic Bladder Urothelial Carcinoma; Metastatic Renal Pelvis and Ureter Urothelial Carcinoma; Metastatic Ureter Urothelial Carcinoma; Stage IV Bladder Urothelial Carcinoma AJCC v7 |
National Cancer Institute (NCI) |
2017-01-31 | PHASE2 |
| NCT02595931 | ACTIVE_NOT_RECRUITING | Metastatic Colorectal Carcinoma; Metastatic Lung Small Cell Carcinoma; Metastatic Malignant Solid Neoplasm; Metastatic Pancreatic Carcinoma; Refractory Colorectal Carcinoma; Refractory Lung Small Cell Carcinoma; Refractory Malignant Solid Neoplasm; Refractory Pancreatic Carcinoma; Stage III Colorectal Cancer AJCC v8; Stage III Lung Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Colorectal Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Unresectable Colorectal Carcinoma; Unresectable Lung Small Cell Carcinoma; Unresectable Malignant Solid Neoplasm; Unresectable Pancreatic Carcinoma |
National Cancer Institute (NCI) |
2016-07-22 | PHASE1 |
| NCT03896503 | ACTIVE_NOT_RECRUITING | Extensive Stage Lung Small Cell Carcinoma; Extrapulmonary Small Cell Neuroendocrine Carcinoma; Limited Stage Lung Small Cell Carcinoma; Platinum-Resistant Lung Small Cell Carcinoma; Platinum-Sensitive Lung Small Cell Carcinoma; Recurrent Lung Small Cell Carcinoma |
National Cancer Institute (NCI) |
2019-12-30 | PHASE2 |
| NCT02589522 | ACTIVE_NOT_RECRUITING | Metastatic Lung Neuroendocrine Neoplasm; Metastatic Lung Non-Small Cell Carcinoma; Metastatic Lung Small Cell Carcinoma; Metastatic Malignant Neoplasm in the Brain; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8 |
National Cancer Institute (NCI) |
2017-05-22 | PHASE1 |
| NCT03517969 | ACTIVE_NOT_RECRUITING | Castration-Resistant Prostate Carcinoma; Metastatic Prostate Carcinoma; Stage IV Prostate Cancer AJCC v8 |
National Cancer Institute (NCI) |
2019-05-29 | PHASE2 |
| NCT02595892 | ACTIVE_NOT_RECRUITING | Ovarian Serous Tumor; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma |
National Cancer Institute (NCI) |
2016-08-25 | PHASE2 |
| NCT02723864 | Completed | Neoplasms |
National Cancer Institute (NCI)|National Institutes of Health Clinical Center (CC) |
2017-08-09 | Phase 1 |
| NCT02487095 | Active not recruiting | Carcinoma Non-Small -Cell Lung|Ovarian Neoplasms|Small Cell Lung Carcinoma|Uterine Cervical Neoplasms|Carcinoma Neuroendocrine|Extrapulmonary Small Cell Cancer |
National Cancer Institute (NCI)|National Institutes of Health Clinical Center (CC) |
2015-07-30 | Phase 1|Phase 2 |
(data from https://clinicaltrials.gov, updated on 2026-07-31)
Check the
Berzosertib (VE-822)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- Berzosertib (VE-822) Mechanism of Action: ATR Inhibition in Small Cell Lung Cancer Cell Research
- Berzosertib (VE-822): Selectivity & Specificity
- Berzosertib (VE-822) Working Concentration | Cell Culture | Treatment
- Berzosertib (VE-822) Solubility in DMSO
- Berzosertib (VE-822) Stock Solution
- Berzosertib (VE-822) Storage
- Berzosertib (VE-822) Stability
- Berzosertib (VE-822) Combination Database
- Berzosertib (VE-822) Molecular Weight
- Berzosertib (VE-822) SMILES
- Berzosertib (VE-822) CAS Number
- Berzosertib (VE-822) Chemical Structure (2D and 3D)
- Berzosertib (VE-822) IC50 for Cell-based and Cell-free Assays
- Berzosertib (VE-822) MedChemExpress (HY-13902)? Try a better option.
- Berzosertib (VE-822) Axonmedchem (Axon 2452)? Try a better option.
- Berzosertib (VE-822) TargetMol (T2669)? Try a better option.
- Berzosertib (VE-822) AdooQ (A13289)? Try a better option.
- Berzosertib (VE-822) APExBIO (B1383)? Try a better option.
- Berzosertib (VE-822) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.