A Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCybrexa Therapeutics
About this trial
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
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- CBX-12
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov