Azenosertib

DRUG11 trials

Sponsors

K-Group Beta Inc., Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting, OHSU Knight Cancer Institute, K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc, Filipa Lynce, MD

Conditions

Borderline Resectable Pancreatic Ductal AdenocarcinomaBreast CancerBreast Cancer FemaleClinical Stage III Gastric Cancer AJCC v8Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage IV Gastric Cancer AJCC v8Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8Fallopian Tube Cancer

Early Phase 1

Targeted Pathway Inhibition in Patients With Pancreatic Cancer

RecruitingNCT04005690

OHSU Knight Cancer InstituteBorderline Resectable Pancreatic Ductal Adenocarcinoma, Locally Advanced Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Ductal Adenocarcinoma +5

Start: 2019-08-01End: 2028-02-01Target: 90Updated: 2026-02-27

Phase 1

A Study of Azenosertib (ZN-c3) in Participants With Solid Tumors

CompletedNCT04158336

K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, IncSolid Tumor

Start: 2019-11-01End: 2025-05-06Updated: 2026-03-18

A Study of Azenosertib (ZN-c3) in Combination With Gemcitabine in Subjects With Osteosarcoma

CompletedNCT04833582

K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, IncOsteosarcoma

Start: 2021-08-01End: 2024-03-30Updated: 2026-04-03

A Study of Azenosertib (ZN-c3) and Niraparib in Subjects With Platinum-Resistant Ovarian Cancer

CompletedNCT05198804

K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, IncFallopian Tube Cancer, Ovarian Cancer, Platinum-resistant Ovarian Cancer +1

Start: 2022-01-27End: 2026-01-19Updated: 2026-03-18

ZAP-IT: ZN-c3 + Carboplatin + Pembrolizumab in mTNBC

Active, not recruitingNCT06351332

Filipa Lynce, MDBreast Cancer, Breast Cancer Female, HER2-negative Breast Cancer +2

Start: 2024-05-01End: 2029-09-01Target: 78Updated: 2026-01-12

Testing the Combination of the Anticancer Drugs Trastuzumab Deruxtecan (DS-8201a) and Azenosertib (ZN-c3) in Patients With Stomach or Other Solid Tumors

RecruitingNCT06364410

National Cancer Institute (NCI)Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8 +10

Start: 2025-02-03End: 2027-07-08Target: 48Updated: 2026-04-03

PHASE Ib STUDY WITH THE COMBINATION OF LB−100 (PP2A INHIBITOR) AND AZENOSERTIB (WEE1 INHIBITOR) IN PATIENTS WITH METASTATIC COLORECTAL CANCER The COLLEE trial

SuspendedCTIS2024-511227-33-00

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis StichtingMetastatic colorectal cancer

Target: 43Updated: 2024-11-08

Phase 2

A Study of Azenosertib (ZN-c3) in Women With Recurrent or Persistent Uterine Serous Carcinoma

CompletedNCT04814108

K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, IncUterine Serous Carcinoma

Start: 2021-07-28End: 2025-10-22Updated: 2026-03-18

A Study of Azenosertib (ZN-c3) in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer

RecruitingNCT05128825

K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, IncHigh-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Start: 2022-02-17End: 2027-06-30Target: 170Updated: 2026-03-24

A Phase 2 Open-label, multicenter study to evaluate efficacy and safety of ZN-c3 in Adult Women with Recurrent or Persistent Uterine Serous Carcinoma

CompletedCTIS2023-507324-23-00

K-Group Beta Inc.recurrent or persistent uterine serous carcinoma

Start: 2024-05-22End: 2025-10-23Target: 70Updated: 2024-04-11

Azenosertib in Uterine Serous Carcinoma: Biomarker Study

RecruitingNCT06369155

Joyce Liu, MDUterine Cancer, Uterine Carcinoma, Uterine Serous Carcinoma

Start: 2025-03-05End: 2028-01-31Target: 25Updated: 2026-03-02

Related Papers

Abstract B013: Cyclin E1 Positive Protein Status is a Predictive Biomarker of Azenosertib Benefit in Platinum-Resistant Ovarian Cancer: Part 2 of the DENALI Study (GOG-3066)

Molecular Cancer Therapeutics2025-10-22

Abstract B012: Results From the Phase 1 Dose Escalation and Dose Expansion Study of Azenosertib, a WEE1 Inhibitor, in Patients With Advanced Solid Tumors

Molecular Cancer Therapeutics2025-10-22

Abstract 3254: Cell-free DNA molecular response predicts clinical efficacy in HGSOC patients treated with azenosertib

Cancer Research2025-04-21

Abstract 4208: Azenosertib is a potent and selective WEE1 kinase inhibitor with broad antitumor activity across a range of solid tumors

Cancer Research2025-04-21

Phase 1 results of the WEE1 inhibitor, azenosertib, in combination with gemcitabine (gem) in adult and pediatric patients (pts) with relapsed or refractory (R/R) osteosarcoma.

Journal of Clinical Oncology2024-06-013 citations

Abstract B003: Advancing biomarker discovery using a novel window of opportunity (WOO) trial for pancreatic ductal adenocarcinoma: Trial updates

Cancer Research2024-01-16

A window of opportunity trial for metastatic (WOO-M) pancreatic ductal adenocarcinoma (PDAC): A biomarker discovery platform.

Journal of Clinical Oncology2023-01-242 citations

Abstract CT029: Safety and clinical activity of single-agent ZN-c3, an oral WEE1 inhibitor, in a phase 1 trial in subjects with recurrent or advanced uterine serous carcinoma (USC)

Cancer Research2022-06-1514 citations

A phase 1/2 dose-escalation and dose-expansion study of ZN-c3 in combination with gemcitabine in adult and pediatric subjects with relapsed or refractory osteosarcoma.

Journal of Clinical Oncology2022-06-013 citations

Abstract CT016: Clinical activity of single-agent ZN-c3, an oral WEE1 inhibitor, in a phase 1 dose-escalation trial in patients with advanced solid tumors

Cancer Research2021-07-0122 citations