A Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer

Last updated: March 11, 2025
Sponsor: Cybrexa Therapeutics
Overall Status: Active - Recruiting

Phase

2

Condition

Ovarian Cysts

Treatment

CBX-12

Clinical Study ID

NCT06315491
CBX-12-201
  • Ages > 18
  • Female

Study Summary

The purpose of this study is to assess the safety, tolerability, and efficacy of CBX-12 in female subjects with platinum resistant or refractory ovarian cancer at 2 doses; 125 mg/m2 every 21 days or 100 mg/m2 every 21 days.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects must have histologically- or cytologically-diagnosed epithelial high-gradeserous cancer of the ovary, fallopian tube cancer or primary peritoneum cancer thatis refractory to prior therapy and must have platinum-resistant disease defined as:

  • Subjects who have received only 1 platinum-based chemotherapy regimen for atleast 4 cycles of platinum must have disease progression on treatment oroccurring ≤ 26 weeks after their last dose of platinum.

  • Patients who have progressed following a second course of a platinum basedregimen.

  • Subjects may have up to 2 additional systemic regimens for advanced ormetastatic disease. Maintenance regimens (e.g., with a PARP inhibitor orbevacizumab) are not considered separate regimens.

  • Age greater than or equal to 18 years at the time of signing the informed consentform (ICF).

  • Has measurable disease per RECIST 1.1.

  • Has provided written informed consent.

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

  • Adequate liver, renal, hematologic, pulmonary and coagulation function.

Exclusion

Exclusion Criteria:

  • Cytotoxic chemotherapy, biologic agent, investigational agent, or radiation therapywithin 3 weeks prior to the first dose of CBX-12.

  • Subjects who are currently receiving any other anticancer or investigationalagent(s).

  • Clinically significant intercurrent disease.

  • Active human immunodeficiency virus (HIV) infection.

  • Active hepatitis B or C infection.

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: CBX-12
Phase: 2
Study Start date:
September 25, 2024
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • Honor Health

    Scottsdale, Arizona 85260
    United States

    Site Not Available

  • Arizona Oncology Associates

    Tucson, Arizona 85711
    United States

    Site Not Available

  • Usc Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • Yale University School of Medicine

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • D&H Cancer Research Center

    Margate, Florida 33063
    United States

    Active - Recruiting

  • South Florida Gynecology

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • Northwest Cancer Centers

    Dyer, Indiana 46311
    United States

    Site Not Available

  • Norton Cancer Institute

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • Women's Cancer Care

    Covington, Louisiana 70433
    United States

    Active - Recruiting

  • Albert Einstein College of Medicine Montefiore Medical

    New York, New York 10021
    United States

    Active - Recruiting

  • Pci Nyu Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

  • University Hospitals Seidman Cancer Center

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Oncology Associate or Oregon

    Eugene, Oregon 97401
    United States

    Site Not Available

  • Sidney Kimmel Medical College at Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Allegheny Singer Research Institute D/B/A Ahn Research Institution

    Pittsburgh, Pennsylvania 15212
    United States

    Active - Recruiting

  • Tennessee Oncology

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Mary Crowley Cancer Research

    Dallas, Texas 75251
    United States

    Active - Recruiting

  • Texas Oncology- Gulf Coast

    The Woodlands, Texas 77380
    United States

    Site Not Available

  • Virgina Cancer Specialist

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Multicare Institute For Research & Innovation

    Tacoma, Washington 98405
    United States

    Active - Recruiting

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