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

Recruiting now · Phase 2

Conditions studied: Platinum-resistant Ovarian Cancer, Refractory Ovarian Carcinoma

In brief

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.

Key facts

Study ID

NCT06315491

Run by

Cybrexa Therapeutics

People needed

40

Starts

2024-09-25

Expected to finish

2025-10-01

Last updated by the study team

2025-10-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Allegheny Singer Research Institute D/B/A Ahn Research Institution — Pittsburgh, Pennsylvania, United States (enrolling)
• Mary Crowley Cancer Research — Dallas, Texas, United States (enrolling)
• 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
• Texas Oncology- Gulf Coast — The Woodlands, Texas, United States
• Honor Health — Scottsdale, Arizona, United States
• Multicare Institute For Research & Innovation — Tacoma, Washington, United States
• Arizona Oncology Associates — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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