RecruitingPhase 2NCT06315491

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

A Randomized Phase 2 Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer


Sponsor

Cybrexa Therapeutics

Enrollment

40 participants

Start Date

Sep 25, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called CBX 12 in women with platinum-resistant or platinum-refractory ovarian cancer, fallopian tube cancer, or primary peritoneal cancer — cancers that have stopped responding to standard platinum-based chemotherapy. CBX 12 is an experimental targeted therapy being evaluated for safety and effectiveness. **You may be eligible if...** - You have high-grade serous cancer of the ovary, fallopian tube, or peritoneum confirmed by biopsy - Your cancer has progressed during or within 26 weeks of completing platinum-based chemotherapy (platinum-resistant), or progressed while actively receiving platinum (platinum-refractory) - You have received 1–2 additional treatment regimens for advanced disease (maintenance therapies like PARP inhibitors do not count as separate regimens) - You are 18 years or older with adequate organ function **You may NOT be eligible if...** - Your cancer is not high-grade serous type - You have received more than 2 additional lines of systemic therapy beyond platinum - You have serious organ dysfunction or other conditions preventing safe participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCBX-12

CBX-12 is an alphalex construct which contains exatecan as the pharmacologically active moiety.


Locations(17)

Honor Health

Scottsdale, Arizona, United States

Arizona Oncology Associates

Tucson, Arizona, United States

Usc Norris Comprehensive Cancer Center

Los Angeles, California, United States

Yale University School of Medicine

New Haven, Connecticut, United States

D&H Cancer Research Center

Margate, Florida, United States

South Florida Gynecology

Tampa, Florida, United States

Northwest Cancer Centers

Dyer, Indiana, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Women's Cancer Care

Covington, Louisiana, United States

Pci Nyu Langone Health

New York, New York, United States

Albert Einstein College of Medicine Montefiore Medical

New York, New York, United States

University Hospitals Seidman Cancer Center

Cleveland, Ohio, United States

Oncology Associates of Oregon

Eugene, Oregon, United States

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

Pittsburgh, Pennsylvania, United States

Mary Crowley Cancer Research

Dallas, Texas, United States

Texas Oncology- Gulf Coast

The Woodlands, Texas, United States

Multicare Institute For Research & Innovation

Tacoma, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06315491


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