Loading clinical trials...

A Study of Azenosertib (ZN-c3) in Participants With Solid Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT04158336•K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Major Eligibility Criteria:
•1. Age ≥ 18 years or the minimum legal adult age (whichever is greater) at the time of informed consent.
•2. Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
•3. Adequate hematologic and organ function.
•4. Female subjects of childbearing potential and male subjects must agree to use an effective method of contraception and for 6 months and 90 days, respectively, after the last dose of ZN-c3.
•1. Subjects must have a solid tumor with advanced or metastatic disease, refractory to standard therapy or for whom no standard therapy is available, or the subject is ineligible for standard therapy(ies).
•2. Measurable or evaluable disease per RECIST version 1.1.
•1. Subjects with solid tumors with advanced or metastatic disease who are refractory or ineligible to standard therapy(ies) or for whom no standard therapy is available.
•2. Subjects must have no relevant dietary restrictions, and be willing to consume a high-calorie, high-fat breakfast and other standard meals provided during the study.
•1. Measurable disease, defined as at least one lesion that can be accurately measured per RECIST version 1.1 criteria.
+1 more criteria

Exclusion Criteria

•1. Prior therapy with ZN-c3 or known hypersensitivity to any drugs similar to ZN-c3 in class or any inactive ingredients present in ZN-c3.
•2. Prior therapy with a WEE1 inhibitor.
•3. A serious illness or medical condition(s).
•4. Unresolved toxicity of Grade \>1 attributed to any prior therapies (excluding Grade ≤2 neuropathy, alopecia or skin pigmentation).
•5. Pregnant or lactating females (including the cessation of lactation) or females of childbearing potential who have a positive serum pregnancy test within 14 days prior to C1D1.
•6. Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.
•7. 12-lead ECG demonstrating a corrected QT interval using Fridericia's formula (QTcF) of \>480 ms, except for subjects with atrioventricular pacemakers or other conditions (e.g., right bundle branch block) that render the QT measurement invalid.
•8. History or current evidence of congenital or family history of long QT syndrome or Torsade de Pointes (TdP).

Locations (8)

Site 0102

Tucson, Arizona, United States

Site 0167

Newport Beach, California, United States

Site 0171

Chicago, Illinois, United States

Site 0101

Detroit, Michigan, United States

Site 0173

New York, New York, United States

Site 0179

Pittsburgh, Pennsylvania, United States

Site 0103

Houston, Texas, United States

Site 0100

San Antonio, Texas, United States

Key Dates

Start Date

November 1, 2019

Primary Completion Date

May 6, 2025

Completion Date

May 6, 2025

Last Updated

March 18, 2026

Enrollment

274

ACTUAL participants

Conditions

Solid Tumor

Interventions

Azenosertib

DRUG

A Study of PYX-201 in Advanced Solid Tumors

NCT05720117

Solid TumorAdvanced Solid Tumor

View study

RECRUITINGPHASE1/PHASE2

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

NCT06898450

Advanced Solid Tumors CancerMSI-H Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of PYX-201 in Advanced Solid Tumors

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

Anti-HER2 CAR-T Cell Injection in Patients With HER2-positive Advanced Malignant Solid Tumors

A Study of ASP1002 in Adults for Treatment of Solid Tumors

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid Tumors