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A Study of ZN-c3 in Subjects With Malignant Tumors

Sponsor
K-Group Beta (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05128825
Collaborator
(none)
105
Enrollment
15
Locations
56.9
Anticipated Duration (Months)
7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase 2 open-label, multicenter study to evaluate the clinical activity, safety, pharmacokinetics (PK), and biomarker profile of ZN-c3 in subjects with locally advanced or metastatic solid tumor malignancies harboring biomarkers related to deoxyribonucleic acid (DNA) damage pathways

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
105 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A PHASE 2 OPEN-LABEL, MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF ZN-c3 IN SUBJECTS WITH MALIGNANT TUMORS HARBORING DNA DAMAGE PATHWAY BIOMARKERS (ZN-c3-005/ GOG-3066/DENALI)
Actual Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Apr 30, 2025
Anticipated Study Completion Date :
Oct 31, 2025

Outcome Measures

Primary Outcome Measures

  1. To investigate the antitumor activity of ZN-c3 based on the ORR [2 years]

    To determine the ORR as defined by the revised RECIST Guideline Version 1.1 and as assessed by ICR.

Secondary Outcome Measures

  1. To further investigate the antitumor activity of ZN-c3 based on DOR [2 years]

    DOR as defined by the revised RECIST Guideline Version 1.1 and as assessed by ICR.

  2. To further investigate the antitumor activity of ZN-c3 based on PFS [2 years]

    PFS as defined by the revised RECIST Guideline Version 1.1 and as assessed by ICR.

  3. To investigate the safety and tolerability of ZN-c3 [2 years]

    Frequency and severity of AEs, including laboratory abnormalities graded according to the NCI-CTCAE Version 5.0.

  4. To investigate OS of subjects receiving ZN-c3 [2 years]

    OS

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Provision of signed informed consent (obtained according to institutional guidelines) prior to initiation of any study-related procedures.

  2. Age ≥18 years at the time of informed consent.

  3. Locally advanced or metastatic malignancy with one or more relevant biomarkers related to deoxyribonucleic acid (DNA) damage pathways

  4. Subjects must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the Investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy, or no standard therapy exists for their tumor type/stage. Prior treatment with immune checkpoint inhibitors is allowed.

  5. Subjects must have at least one measurable lesion as defined by RECIST Guideline Version 1.1.

  6. Performance Status: Eastern Cooperative Oncology Group (ECOG) score of ≤2.

  7. Adequate hematologic and organ function

  8. Willingness and ability to release archival tissue

  9. Females of childbearing potential and male subjects must agree to use an effective method of contraception prior to the first dose and for 90 days after the last dose of ZN-c3.

  10. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:
    1. Any of the following treatment interventions within the specified time frame prior to C1D1:

  2. Major surgery within 28 days (any surgical incision should be fully healed prior to study drug administration);

  3. Any chemotherapy within 14 days or 5 half-lives (whichever is shorter);

  4. Radiation therapy within 21 days; however, if the radiation portal covered ≤5% of the bone marrow, the subject is eligible irrespective of the end date of radiotherapy.

  5. Autologous or allogeneic stem cell transplant within 3 months.

  6. Current use of any other investigational drug therapy <28 days or 5 half-lives (whichever is shorter).

  7. Inability to discontinue treatment prescription or non-prescription drugs, or to discontinue consumption of food and herbal supplements, that are strong/moderate CYP3A4 inhibitors, P-gp inhibitors, or strong CYP3A4 inducers at least 14 days prior to start of study drug treatment

  8. Prior therapy with ZN-c3 or any other WEE1 inhibitor.

  9. A serious illness or medical condition(s)

  10. Unresolved toxicity of Grade >1 attributed to any prior therapies (excluding Grade ≤2 neuropathy, alopecia or skin pigmentation).

  11. 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.

  12. Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.

  13. Individuals who are judged by the Investigator to be unsuitable as study subjects.

  14. 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.

  1. History or current evidence of congenital or family history of long QT syndrome or Torsade de Pointes (TdP).

  2. Taking medications with a known risk of TdP.

  3. Concomitant medication that leads to significant QT prolongation.

  4. Administration of strong or moderate CYP3A4 inhibitors or inducers and P-gp inhibitors

Contacts and Locations

Locations

Site City State Country Postal Code
1 Site 0135 - Rocky Mountain Cancer Centers Lone Tree Colorado United States 80218
2 Site 0291 - CRC Cancer Centers of Brevard Melbourne Florida United States 32935
3 Site 0236 - Memorial Health Savannah Georgia United States 31404
4 Site 0146 - Maryland Oncology Hematology, PA Rockville Maryland United States 20876
5 Site 0213 - Center of Hope Reno Nevada United States 89511
6 Site 0257 - Columbus NCORP Columbus Ohio United States 43215
7 Site 0262 - Lancaster General Hospital Lancaster Pennsylvania United States 17602
8 Site 0277 - Alliance Cancer Specialist, PC Wynnewood Pennsylvania United States 19096
9 Site 0260 - Monument Health Rapid City Hospital Rapid City South Dakota United States 57701
10 Site 0293 - Texas Oncology - Amarillo Amarillo Texas United States 79106
11 Site 0142 - Texas Oncology - Baylor Charles A. Sammons Cancer Center Dallas Texas United States 75246
12 Site 0201 - Texas Oncology McKinney Texas United States 75071
13 Site 0203 - Texas Oncology Tyler Texas United States 75702
14 Site 0269 - Oncology & Hematology Associates of Southwest Virginia, Inc. Roanoke Virginia United States 24014
15 Site 0153 - University of Wisconsin Clinical Science Center Madison Wisconsin United States 53792

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:
NCT05128825
Other Study ID Numbers:
  • ZN-c3-005
First Posted:
Nov 22, 2021
Last Update Posted:
Aug 19, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of Aug 19, 2022