RECRUITING

A Study of ZN-c3 in Participants With Solid Tumors

Conditions

Solid Tumor Uterine Serous Carcinoma Solid Tumors Harboring Biomarkers Related to DNA Damage Pathways

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2019-11-01

Study Completion:2023-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04158336

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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. 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).

Inclusion Criteria

Exclusion Criteria

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. 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).

Contacts and Locations

Study Contact

Project Director

CONTACT

858-263-4333

medicalaffairs@zentalis.com

Principal Investigator

Philippe Pultar, MD

STUDY_DIRECTOR

K-Group Beta, a Zentalis Company

Study Locations (Sites)

Site 0102

Tucson, Arizona, 85719

United States

Site 0167

Newport Beach, California, 92663

United States

Site 0171

Chicago, Illinois, 60637

United States

Site 0101

Detroit, Michigan, 48201

United States

Site 0173

New York, New York, 10029

United States

Site 0179

Pittsburgh, Pennsylvania, 15213

United States

Site 0103

Houston, Texas, 77030

United States

Site 0100

San Antonio, Texas, 78229

United States

Collaborators and Investigators

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

Philippe Pultar, MD, STUDY_DIRECTOR, K-Group Beta, a Zentalis Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-11-01

Study Completion Date2023-08

Study Record Updates

Study Start Date2019-11-01

Study Completion Date2023-08

Terms related to this study

Keywords Provided by Researchers

Uterine Serous Carcinoma
Solid Tumors Harboring Biomarkers Related to DNA Damage Pathways

Additional Relevant MeSH Terms

Solid Tumor