Clinical Trials

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 Protocol recruitment statuses range from active and recruiting to completed, terminated, and withdrawn.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)

Check the Azenosertib (Zn-C3) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Azenosertib (Zn-C3) selectively binds to and inhibits Wee1 kinase, thereby blocking Wee1-mediated inhibitory phosphorylation of cyclin-dependent kinase 1 (CDK1) at tyrosine-15 and abrogating the G2/M cell cycle checkpoint. This unscheduled checkpoint bypass forces cancer cells with existing DNA damage into premature mitosis, causing severe chromosomal fragmentation, mitotic catastrophe, and cell death, which underpins its clinical utility in treating malignancies such as uterine serous carcinoma, ovarian cancer, and acute myeloid leukemia.

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>).

Note: Technical data last updated: Sep 1, 2026.