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New treatment option for Platinum-resistant Ovarian Cancer
Official title A Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer
ClinicalTrials.gov ID: NCT06315491
What this study is testing
What is CBX-12?
CBX-12 is an investigational medicine, being studied as a potential treatment for platinum-resistant ovarian cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- people must have histologically- or cytologically-diagnosed epithelial high-grade serous cancer of the ovary, fallopian tube cancer or primary...
- people who have received only 1 platinum-based chemotherapy regimen for at least 4 cycles of platinum must have disease progression on treatment or...
- Patients who have progressed following a second course of a platinum based regimen.
- people may have up to 2 additional systemic regimens for advanced or metastatic disease. Maintenance regimens (e.g., with a PARP inhibitor or...
- Age greater than or equal to 18 years at the time of signing the informed consent form (ICF).
You likely can't join if
- Cytotoxic chemotherapy, biologic agent, investigational agent, or radiation therapy within 3 weeks prior to the first dose of CBX-12.
- people 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.
See the full eligibility criteria
- people 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...
- people 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.
- people 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.
- Cytotoxic chemotherapy, biologic agent, investigational agent, or radiation therapy within 3 weeks prior to the first dose of CBX-12.
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Tucson, Arizona, United States
- Los Angeles, California, United States
- New Haven, Connecticut, United States
- Margate, Florida, United States
- Tampa, Florida, United States
- Dyer, Indiana, United States
- Louisville, Kentucky, United States
- Covington, Louisiana, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Eugene, Oregon, United States
- Pittsburgh, Pennsylvania, United States
- Dallas, Texas, United States
- The Woodlands, Texas, United States
- Tacoma, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Tucson, Arizona, United States; Los Angeles, California, United States; New Haven, Connecticut, United States; Margate, Florida, United States; Tampa, Florida, United States and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.