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NCT06315491 | RECRUITING | Platinum-resistant Ovarian Cancer

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

Cybrexa Therapeutics

Brief 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.

Condition or disease

Platinum-resistant Ovarian Cancer

Refractory Ovarian Carcinoma

Intervention/treatment

CBX-12

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 60 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Randomized Phase 2 Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer
Actual Study Start Date : 2024-09-25
Estimated Primary Completion Date : 2026-04
Estimated Study Completion Date : 2026-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Subjects must have histologically- or cytologically-diagnosed epithelial high-grade serous cancer of the ovary, fallopian tube cancer or primary peritoneum cancer that is refractory to prior therapy and must have platinum-resistant disease defined as
    • * Subjects who have received only 1 platinum-based chemotherapy regimen for at least 4 cycles of platinum must have disease progression on treatment or occurring ≤ 26 weeks after their last dose of platinum.
    • * Patients who have progressed following a second course of a platinum based regimen.
    • * Subjects may have up to 2 additional systemic regimens for advanced or metastatic disease. Maintenance regimens (e.g., with a PARP inhibitor or bevacizumab) are not considered separate regimens.
    • * Age greater than or equal to 18 years at the time of signing the informed consent form (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 Criteria
    • * Cytotoxic chemotherapy, biologic agent, investigational agent, or radiation therapy within 3 weeks prior to the first dose of CBX-12.
    • * Subjects who are currently receiving any other anticancer or investigational agent(s).
    • * Clinically significant intercurrent disease.
    • * Active human immunodeficiency virus (HIV) infection.
    • * Active hepatitis B or C infection.
A Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer

Location Details

NCT06315491

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, Arizona

Honor Health

Scottsdale, Arizona, United States, 85260

NOT YET RECRUITING

United States, Arizona

Arizona Oncology Associates

Tucson, Arizona, United States, 85711

RECRUITING

United States, California

Usc Norris Comprehensive Cancer Center

Los Angeles, California, United States, 90033

RECRUITING

United States, Connecticut

Yale University School of Medicine

New Haven, Connecticut, United States, 06510

RECRUITING

United States, Florida

D&H Cancer Research Center

Margate, Florida, United States, 33063

RECRUITING

United States, Florida

South Florida Gynecology

Tampa, Florida, United States, 33606

NOT YET RECRUITING

United States, Indiana

Northwest Cancer Centers

Dyer, Indiana, United States, 46311

RECRUITING

United States, Kentucky

Norton Cancer Institute

Louisville, Kentucky, United States, 40202

RECRUITING

United States, Louisiana

Women's Cancer Care

Covington, Louisiana, United States, 70433

RECRUITING

United States, New York

Pci Nyu Langone Health

New York, New York, United States, 10016

RECRUITING

United States, New York

Albert Einstein College of Medicine Montefiore Medical

New York, New York, United States, 10021

RECRUITING

United States, Ohio

University Hospitals Seidman Cancer Center

Cleveland, Ohio, United States, 44106

NOT YET RECRUITING

United States, Oregon

Oncology Associate or Oregon

Eugene, Oregon, United States, 97401

NOT YET RECRUITING

United States, Pennsylvania

Sidney Kimmel Medical College at Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

RECRUITING

United States, Pennsylvania

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

Pittsburgh, Pennsylvania, United States, 15212

NOT YET RECRUITING

United States, Tennessee

Tennessee Oncology

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

Mary Crowley Cancer Research

Dallas, Texas, United States, 75251

NOT YET RECRUITING

United States, Texas

Texas Oncology- Gulf Coast

The Woodlands, Texas, United States, 77380

NOT YET RECRUITING

United States, Virginia

Virgin Cancer Specialist

Fairfax, Virginia, United States, 22031

RECRUITING

United States, Washington

Multicare Institute For Research & Innovation

Tacoma, Washington, United States, 98405