Multiple clinical trials evaluate azenosertib (Zn-C3) across diverse malignancies, including uterine serous carcinoma, ovarian cancer, acute myeloid leukemia, gastroesophageal, colorectal, and advanced solid tumors. Spanning Early Phase 1 through Phase 3, these studies evaluate monotherapy and combination strategies and feature sponsorship from corporate entities like Zentalis Pharmaceuticals alongside academic institutions like the National Cancer Institute. Protocol recruitment statuses range from active and recruiting to completed, terminated, and withdrawn.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT04516447 | RECRUITING | Solid Tumor; Epithelial Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer |
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc |
2020-10-26 | PHASE1 |
| NCT07546500 | RECRUITING | Ovarian Cancer |
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc |
2026-04-17 | PHASE3 |
| NCT06364410 | 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; Locally Advanced Gastric Carcinoma; Locally Advanced Gastroesophageal Junction Adenocarcinoma; Locally Advanced Malignant Solid Neoplasm; Metastatic Gastric Carcinoma; Metastatic Gastroesophageal Junction Adenocarcinoma; Metastatic Malignant Solid Neoplasm; Unresectable Gastric Carcinoma; Unresectable Gastroesophageal Junction Adenocarcinoma; Unresectable Malignant Solid Neoplasm |
National Cancer Institute (NCI) |
2025-02-03 | PHASE1 |
| NCT04005690 | RECRUITING | Locally Advanced Pancreatic Ductal Adenocarcinoma; Metastatic Pancreatic Ductal Adenocarcinoma; Stage II Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Unresectable Pancreatic Ductal Adenocarcinoma; Borderline Resectable Pancreatic Ductal Adenocarcinoma; Resectable Pancreatic Ductal Adenocarcinoma |
OHSU Knight Cancer Institute |
2019-08-01 | EARLY_PHASE1 |
| NCT06369155 | RECRUITING | Uterine Serous Carcinoma; Uterine Carcinoma; Uterine Cancer |
Joyce Liu, MD |
2025-03-05 | PHASE2 |
| NCT05128825 | RECRUITING | High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer |
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc |
2022-02-17 | PHASE2 |
| NCT06351332 | TERMINATED | Breast Cancer; Breast Cancer Female; Triple Negative Breast Cancer; Hormone Receptor Negative Malignant Tumor Breast Triple; HER2-negative Breast Cancer |
Filipa Lynce, MD |
2024-05-01 | PHASE1 |
| NCT04814108 | COMPLETED | Uterine Serous Carcinoma |
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc |
2021-07-28 | PHASE2 |
| NCT05198804 | COMPLETED | Ovarian Cancer; Platinum-resistant Ovarian Cancer; Primary Peritoneal Carcinoma; Fallopian Tube Cancer |
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc |
2022-01-27 | PHASE1; PHASE2 |
| NCT06015659 | ACTIVE_NOT_RECRUITING | Advanced Pancreatic Adenocarcinoma; Pancreatic Cancer; Pancreatic Ductal Adenocarcinoma |
Brandon Huffman, MD |
2023-11-16 | PHASE2 |
| NCT04158336 | COMPLETED | Solid Tumor |
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc |
2019-11-01 | PHASE1 |
| NCT05368506 | WITHDRAWN | Advanced Fallopian Tube Carcinoma; Advanced Ovarian Carcinoma; Advanced Primary Peritoneal Carcinoma; Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Triple-Negative Breast Carcinoma; Stage III Fallopian Tube Cancer AJCC v8; Stage III Ovarian Cancer AJCC v8; Stage III Primary Peritoneal Cancer AJCC v8; Stage IV Fallopian Tube Cancer AJCC v8; Stage IV Ovarian Cancer AJCC v8; Stage IV Primary Peritoneal Cancer AJCC v8 |
OHSU Knight Cancer Institute |
2023-07-30 | EARLY_PHASE1 |
| NCT05743036 | TERMINATED | Metastatic Colorectal Cancer |
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc |
2023-02-27 | PHASE1 |
| NCT05682170 | TERMINATED | Acute Myeloid Leukemia (AML) |
K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc. |
2022-12-01 | PHASE1; PHASE2 |
| NCT04833582 | COMPLETED | Osteosarcoma |
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc |
2021-08-01 | PHASE1 |
| NCT05743036 | Recruiting | Metastatic Colorectal Cancer |
K-Group Beta Inc. a wholly owned subsidiary of Zentalis Pharmaceuticals Inc|Pfizer |
2023-02-27 | Phase 1|Phase 2 |
| NCT05431582 | WITHDRAWN | Tumors; Ovarian Cancer; Breast Cancer; Lung Cancer; Pancreatic Cancer |
M.D. Anderson Cancer Center |
2022-12-14 | PHASE1 |
| NCT05682170 | Recruiting | Acute Myeloid Leukemia (AML) |
K-Group Alpha Inc. a wholly owned subsidiary of Zentalis Pharmaceuticals Inc. |
2022-12-01 | Phase 1|Phase 2 |
| NCT05431582 | Withdrawn | Tumors|Ovarian Cancer|Breast Cancer|Lung Cancer|Pancreatic Cancer |
M.D. Anderson Cancer Center|Zentalis Pharmaceuticals |
2022-12-14 | Phase 1 |
| NCT04972422 | UNKNOWN | Solid Tumors |
Zentera Therapeutics HK Limited |
2021-07-15 | PHASE1 |
| NCT05198804 | Recruiting | Ovarian Cancer|Platinum-resistant Ovarian Cancer|Primary Peritoneal Carcinoma|Fallopian Tube Cancer |
K-Group Beta Inc. a wholly owned subsidiary of Zentalis Pharmaceuticals Inc |
2022-01-27 | Phase 1|Phase 2 |
(data from https://clinicaltrials.gov, updated on 2026-04-07)
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>).
- Azenosertib (Zn-C3) Mechanism of Action: WEE1 Inhibition in Ovarian Cancer Cell Research
- Azenosertib (Zn-C3) Working Concentration | Cell Culture | Treatment
- Azenosertib (Zn-C3) Solubility in DMSO
- Azenosertib (Zn-C3) Stock Solution
- Azenosertib (Zn-C3) Storage
- Azenosertib (Zn-C3) Stability
- Azenosertib (Zn-C3) Combination Database
- Azenosertib (Zn-C3) Molecular Weight
- Azenosertib (Zn-C3) SMILES
- Azenosertib (Zn-C3) CAS Number
- Azenosertib (Zn-C3) Chemical Structure (2D and 3D)
- Azenosertib (Zn-C3) MedChemExpress (HY-132295)? Try a better option.
- Azenosertib (Zn-C3) Sigma (TA9H98DB2335)? Try a better option.
- Azenosertib (Zn-C3) SDS|MSDS