NCT05128825: DENALI

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

Recruiting now Phase 2 Last updated 15 April 2026

What this trial tests

Phase 2 trial testing azenosertib in High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer in 310 participants. Currently enrolling.

Timeline

17 February 2022

Primary endpoint
1 December 2026

30 June 2027

Quick facts

Lead sponsor	K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	310
Start date	17 February 2022
Primary completion	1 December 2026
Estimated completion	30 June 2027
Sites	90 locations across France, Italy, Belgium, Poland, South Korea, Australia, United States, Spain

Drugs / interventions tested

• azenosertib — full drug profile →

Conditions studied

• High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer — all drugs for High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer →

Sponsor

K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc — full company profile →

Who can join

18 and older, female only, with High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multi-part Phase 2 study to evaluate the efficacy and safety of azenosertib (ZN-c3) in subjects with Platinum-Resistant, High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Part 2 of the study will be conducted in subjects whose tumors are Cyclin E1 positive as determined by central review using the Sponsor's investigational clinical trial assay.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. A new wave of innovations within the DNA damage response.
   Li Q, Qian W, Zhang Y, Hu L, et al · · 2023 · cited 85× · PMID 37679326 · DOI 10.1038/s41392-023-01548-8
2. Targeting the DNA damage response for cancer therapy.
   Curtin NJ. · · 2023 · cited 30× · PMID 36606678 · DOI 10.1042/bst20220681
3. Cyclers' kinases in cell division: from molecules to cancer therapy.
   Milletti G, Colicchia V, Cecconi F. · · 2023 · cited 28× · PMID 37516809 · DOI 10.1038/s41418-023-01196-z
4. Synthetic and Medicinal Chemistry Approaches Toward WEE1 Kinase Inhibitors and Its Degraders.
   Alli VJ, Yadav P, Suresh V, Jadav SS. · · 2023 · cited 18× · PMID 37323408 · DOI 10.1021/acsomega.3c01558
5. DNA repair and the contribution to chemotherapy resistance.
   Nesic K, Parker P, Swisher EM, Krais JJ. · · 2025 · cited 16× · PMID 40420317 · DOI 10.1186/s13073-025-01488-8
6. Targeting the DNA damage response in cancer.
   Federica G, Michela C, Giovanna D. · · 2024 · cited 12× · PMID 39492835 · DOI 10.1002/mco2.788
7. Perspectives on cancer therapy-synthetic lethal precision medicine strategies, molecular mechanisms, therapeutic targets and current technical challenges.
   Peng S, Long M, Chen Q, Yin Z, et al · · 2025 · cited 8× · PMID 40240755 · DOI 10.1038/s41420-025-02418-8
8. The interplay of DNA damage, epigenetics and tumour heterogeneity in driving cancer cell fitness.
   Rouault CD, Charafe-Jauffret E, Ginestier C. · · 2025 · cited 3× · PMID 41028732 · DOI 10.1038/s41467-025-64445-4