A Study of ZN-c3 in Combination With Gemcitabine in Subjects With Osteosarcoma

November 10, 2023 updated by: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

A Phase 1/2 Dose Escalation and Dose Expansion Study of ZN-c3 in Combination With Gemcitabine in Adult and Pediatric Subjects With Relapsed or Refractory Osteosarcoma

This is a phase 1/2 study of ZN-c3 in combination with gemcitabine in adult and pediatric subjects with relapsed or refractory osteosarcoma.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a phase 1/2 dose escalation and dose expansion study, evaluating the clinical activity and safety, pharmacodynamics, and pharmacokinetics of ZN-c3 in combination with gemcitabine in relapsed or refractory osteosarcoma.

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bordeaux, France, 33000
        • Site 3604
      • Lyon, France, 69008
        • Site 3601
      • Marseille, France, 13385
        • Site 3602
      • Paris, France, 75248
        • Site 3606
      • Toulouse, France, 31100
        • Site 3605
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Site 0106
      • Oakland, California, United States, 94609
        • Site 0124
      • Santa Monica, California, United States, 90403
        • Site 0195
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida College of Medicine
    • New York
      • New York, New York, United States, 10065
        • Site 0105
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Site 0107
    • Oregon
      • Portland, Oregon, United States, 97239
        • Site 0123
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • Site 0193
      • Nashville, Tennessee, United States, 37332
        • Site 0197
    • Texas
      • Houston, Texas, United States, 77030
        • Site 0103
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Site 0188
    • Washington
      • Seattle, Washington, United States, 98195
        • Site 0122

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.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 12 years at the time of informed consent
  • Bodyweight ≥ 40 kg
  • Histologically documented relapsed or metastatic osteosarcoma.
  • Must have measurable disease according to RECIST Guideline version 1.1 criteria.
  • Adequate hematologic and organ function.
  • Female subjects of childbearing potential and male subjects must agree to use an effective method of contraception per institutional standard prior to the first dose and for 6 months after study treatment discontinuation.
  • Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  • Unresolved toxicity of Grade >1 attributed to prior therapies (excluding: Grade ≤2 neuropathy, alopecia, or skin pigmentation)
  • Prior therapy with a WEE1 inhibitor
  • A serious illness or medical condition(s).
  • Pregnant or lactating females. Females of childbearing potential with a positive serum pregnancy test <14 days to Day 1.
  • Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.
  • 12-lead ECG demonstrating a corrected QT interval using Fridericia's formula (QTcF) of >470 ms, except for subjects with atrioventricular pacemakers or other conditions (e.g., right bundle branch block) that render the QT measurement invalid.
  • History or current evidence of congenital or family history of long QT syndrome or Torsades de Pointes (TdP).
  • Taking medications with a known risk of TdP.
  • Administration of strong and moderate CYP3A4 inhibitors/inducers and strong and moderate P-gp inhibitors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combination ZN-c3 with Gemcitabine
Drug: ZN-c3
ZN-c3 is an investigational drug.
Drug: Gemcitabine
Gemcitabine is an approved drug
Other Names:
  • Gemzar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of dose-limiting toxicities (DLT) in DLT evaluable subjects and the incidence and severity of adverse events.
Time Frame: Through Cycle 1 (21 days) Phase 1
Through Cycle 1 (21 days) Phase 1
Event-free survival (EFS) at 18 weeks per RECIST (Response Evaluation Criteria in Solid Tumors) Guideline version 1.1.
Time Frame: During phase 2, at 18 weeks
EFS at 18 weeks is defined as time from study enrollment until date of disease progression, or detection of disease at a previously uninvolved site, or date of death of the subjects at 18 weeks.
During phase 2, at 18 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-free survival (EFS) per RECIST Guideline version 1.1.
Time Frame: At 12 months
EFS is defined as time from study enrollment until date of last contact, date of disease progression, or detection of disease at a previously uninvolved site, or date of death.
At 12 months
Median overall survival (OS) and OS at 12 months per RECIST Guideline version 1.1.
Time Frame: At 12 months
OS is defined as the time from date of first dosing until the date of death.
At 12 months
The frequency and severity of adverse events (AEs) and laboratory abnormalities per the National Cancer Institute Common Terminology (NCI CTCAE) version 5.0.lities.
Time Frame: Through completion, approximately 42 months
Through completion, approximately 42 months
Plasma pharmacokinetics (PK) maximum concentration (Cmax).
Time Frame: Through completion, approximately 42 months
Through completion, approximately 42 months
Plasma PK time to maximum concentration (Tmax).
Time Frame: Through completion, approximately 42 months
Through completion, approximately 42 months
Area under the plasma concentration versus timepoint curve (AUC last).
Time Frame: Through completion, approximately 42 months
Through completion, approximately 42 months
Terminal half-life of the plasma PK concentration.
Time Frame: Through completion, approximately 42 months
Through completion, approximately 42 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

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 Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Actual)

August 30, 2023

Study Completion (Estimated)

December 30, 2023

Study Registration Dates

First Submitted

March 25, 2021

First Submitted That Met QC Criteria

April 2, 2021

First Posted (Actual)

April 6, 2021

Study Record Updates

Last Update Posted (Estimated)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 10, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZN-c3-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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