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

Sponsor
K-Group Beta (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04833582
Collaborator
(none)
84
Enrollment
16
Locations
1
Arm
28.9
Anticipated Duration (Months)
5.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
84 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Aug 1, 2021
Anticipated Primary Completion Date :
Aug 30, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of dose-limiting toxicities (DLT) in DLT evaluable subjects and the incidence and severity of adverse events. [Through Cycle 1 (21 days) Phase 1]

    2. Event-free survival (EFS) at 18 weeks per RECIST (Response Evaluation Criteria in Solid Tumors) Guideline version 1.1. [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.

    Secondary Outcome Measures

    1. Event-free survival (EFS) per RECIST Guideline version 1.1. [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.

    2. Median overall survival (OS) and OS at 12 months per RECIST Guideline version 1.1. [At 12 months]

      OS is defined as the time from date of first dosing until the date of death.

    3. The frequency and severity of adverse events (AEs) and laboratory abnormalities per the National Cancer Institute Common Terminology (NCI CTCAE) version 5.0.lities. [Through completion, approximately 42 months]

    4. Plasma pharmacokinetics (PK) maximum concentration (Cmax). [Through completion, approximately 42 months]

    5. Plasma PK time to maximum concentration (Tmax). [Through completion, approximately 42 months]

    6. Area under the plasma concentration versus timepoint curve (AUC last). [Through completion, approximately 42 months]

    7. Terminal half-life of the plasma PK concentration. [Through completion, approximately 42 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site 0106 Los Angeles California United States 90095
    2 Site 0124 Oakland California United States 94609
    3 Site 0195 Santa Monica California United States 90403
    4 Site 0105 New York New York United States 10065
    5 Site 0107 Cincinnati Ohio United States 45229
    6 Site 0123 Portland Oregon United States 97239
    7 Site 0193 Memphis Tennessee United States 38105
    8 Site 0197 Nashville Tennessee United States 37332
    9 Site 0103 Houston Texas United States 77030
    10 Site 0188 Richmond Virginia United States 23298
    11 Site 0122 Seattle Washington United States 98195
    12 Site 3604 Bordeaux France 33000
    13 Site 3601 Lyon France 69008
    14 Site 3602 Marseille France 13385
    15 Site 3606 Paris France 75248
    16 Site 3605 Toulouse France 31100

    Sponsors and Collaborators

    • K-Group Beta

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    K-Group Beta
    ClinicalTrials.gov Identifier:
    NCT04833582
    Other Study ID Numbers:
    • ZN-c3-003
    First Posted:
    Apr 6, 2021
    Last Update Posted:
    Aug 10, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Osteosarcoma
    Gemcitabine

    Study Results

    No Results Posted as of Aug 10, 2022