A Study of ZN-c3 in Participants With Solid Tumors

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.

Conditions

Solid Tumor

Study Overview

Study Details

Study overview

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.

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

A Study of ZN-c3 in Participants With Solid Tumors

Condition
Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Tucson

Site 0102, Tucson, Arizona, United States, 85719

Newport Beach

Site 0167, Newport Beach, California, United States, 92663

Chicago

Site 0171, Chicago, Illinois, United States, 60637

Detroit

Site 0101, Detroit, Michigan, United States, 48201

New York

Site 0173, New York, New York, United States, 10029

Pittsburgh

Site 0179, Pittsburgh, Pennsylvania, United States, 15213

Houston

Site 0103, Houston, Texas, United States, 77030

San Antonio

Site 0100, San Antonio, Texas, United States, 78229

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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).

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2023-08