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NCT06315491PHASE2Recruiting

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

Cybrexa Therapeutics

Start Date

9/25/2024

Completion Date

10/1/2025

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

Age Range: 18 years to No maximum

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.

Interventions

DRUG

CBX-12

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Conditions

Platinum-resistant Ovarian CancerRefractory Ovarian Carcinoma

Locations

Honor Health

Scottsdale, Arizona 85260

United States

Arizona Oncology Associates

Tucson, Arizona 85711

United States

Usc Norris Comprehensive Cancer Center

Los Angeles, California 90033

United States

Yale University School of Medicine

New Haven, Connecticut 06510

United States

D&H Cancer Research Center

Margate, Florida 33063

United States

South Florida Gynecology

Tampa, Florida 33606

United States

Northwest Cancer Centers

Dyer, Indiana 46311

United States

Norton Cancer Institute

Louisville, Kentucky 40202

United States

Women's Cancer Care

Covington, Louisiana 70433

United States

Pci Nyu Langone Health

New York, New York 10016

United States

Albert Einstein College of Medicine Montefiore Medical

New York, New York 10021

United States

University Hospitals Seidman Cancer Center

Cleveland, Ohio 44106

United States

Oncology Associates of Oregon

Eugene, Oregon 97401

United States

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

Pittsburgh, Pennsylvania 15212

United States

Mary Crowley Cancer Research

Dallas, Texas 75251

United States

Texas Oncology- Gulf Coast

The Woodlands, Texas 77380

United States

Multicare Institute For Research & Innovation

Tacoma, Washington 98405

United States