NCT04158336

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

A Phase 1 Study of ZN-c3 as a Single Agent in Subjects With Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 274 (actual)
• Sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 open-label, multicenter study of ZN-c3 (also known as Azenosertib) monotherapy which consists of Dose Escalation, a Food Effect Cohort, and Dose Expansion.

Detailed description

This study will evaluate the safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics of ZN-c3. In Dose Escalation, the study will identify the Maximum Tolerated Dose (MTD) of ZN-c3 monotherapy in solid tumors. The Food Effect cohort sub-study will examine ZN-c3 PK after a single dose and determine the bioavailability of ZN-c3 under fed and fasted conditions. In Dose Expansion, single agent ZN-c3 will be evaluated at the RP2D in subjects with recurrent or persistent uterine serous carcinoma (USC) or subjects with locally advanced or metastatic solid tumor malignancies harboring biomarkers related to deoxyribonucleic acid (DNA) damage pathways.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	Azenosertib	Azenosertib (ZN-c3) is a study drug

Timeline

• Start date: 2019-11-01
• Primary completion: 2025-05-06
• Completion: 2025-05-06
• First posted: 2019-11-08
• Last updated: 2026-03-18

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study