Testing CBX-12 for women with hard-to-treat ovarian cancer
A Randomized Phase 2 Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer
PHASE2 · Cybrexa Therapeutics · NCT06315491
This study is testing a new drug called CBX-12 to see if it can help women with hard-to-treat ovarian cancer feel better when other treatments haven't worked.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Cybrexa Therapeutics (industry) |
| Drugs / interventions | bevacizumab, chemotherapy, radiation |
| Locations | 17 sites (Scottsdale, Arizona and 16 other locations) |
| Trial ID | NCT06315491 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, tolerability, and efficacy of a drug called CBX-12 in women diagnosed with platinum-resistant or refractory ovarian cancer. Participants will receive either 125 mg/m2 or 100 mg/m2 of CBX-12 every 21 days. The study aims to determine how well the drug works in this specific patient population, which has limited treatment options due to resistance to platinum-based therapies.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with histologically or cytologically diagnosed high-grade serous ovarian cancer that is refractory to prior platinum-based therapies.
Not a fit: Patients who have not received prior platinum-based chemotherapy or those with non-serous ovarian cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for women with platinum-resistant ovarian cancer.
How similar studies have performed: While there have been studies on various treatments for ovarian cancer, the specific approach with CBX-12 in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Scottsdale, Arizona and 16 other locations
- Honor Health — Scottsdale, Arizona, United States (WITHDRAWN)
- Arizona Oncology Associates — Tucson, Arizona, United States (ACTIVE_NOT_RECRUITING)
- Usc Norris Comprehensive Cancer Center — Los Angeles, California, United States (ACTIVE_NOT_RECRUITING)
- Yale University School of Medicine — New Haven, Connecticut, United States (ACTIVE_NOT_RECRUITING)
- D&H Cancer Research Center — Margate, Florida, United States (ACTIVE_NOT_RECRUITING)
- South Florida Gynecology — Tampa, Florida, United States (ACTIVE_NOT_RECRUITING)
- Northwest Cancer Centers — Dyer, Indiana, United States (WITHDRAWN)
- Norton Cancer Institute — Louisville, Kentucky, United States (ACTIVE_NOT_RECRUITING)
- Women's Cancer Care — Covington, Louisiana, United States (ACTIVE_NOT_RECRUITING)
- Pci Nyu Langone Health — New York, New York, United States (ACTIVE_NOT_RECRUITING)
- Albert Einstein College of Medicine Montefiore Medical — New York, New York, United States (ACTIVE_NOT_RECRUITING)
- University Hospitals Seidman Cancer Center — Cleveland, Ohio, United States (ACTIVE_NOT_RECRUITING)
- Oncology Associates of Oregon — Eugene, Oregon, United States (ACTIVE_NOT_RECRUITING)
- Allegheny Singer Research Institute D/B/A Ahn Research Institution — Pittsburgh, Pennsylvania, United States (RECRUITING)
- Mary Crowley Cancer Research — Dallas, Texas, United States (RECRUITING)
- Texas Oncology- Gulf Coast — The Woodlands, Texas, United States (ACTIVE_NOT_RECRUITING)
- Multicare Institute For Research & Innovation — Tacoma, Washington, United States (ACTIVE_NOT_RECRUITING)
Study contacts
- Study coordinator: Clinical Operations Trial Team
- Email: clinicalstudies@cybrexa.com
- Phone: 860-717-2731
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Platinum-resistant Ovarian Cancer, Refractory Ovarian Carcinoma