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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
CBX-12
DrugCBX-12 is an alphalex construct which contains exatecan as the pharmacologically active moiety.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: CBX-12 - 125mg/m2 q21dExperimental treatment 1 intervention
Group B: CBX-12 - 100mg/m2 q21dExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Subjects With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
ORR is defined as the proportion of subjects achieving a confirmed best overall response (BOR) of CR or PR defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Time frame
Randomization to progressive disease (PD) (Up to approximately 21 months)Secondary outcomes
1
Incidence of Subjects With Treatment Emergent Adverse Events (TEAEs)
Safety as assessed by the incidence of treatment-emergent AEs (TEAEs).
Time frame
First dose of study drug to 30-day post-dose follow up (Up to approximately 21 months)2
Median Duration of Response (DoR)
Duration of response is the interval from the date of initial CR or PR until the first date criteria for PD is met using RECIST v1.1 criteria, or initiation of other (or additional) antitumor therapy is first reported, or death due to any cause.
Time frame
Date of Initial CR or PR to PD (Up to 21 Months)3
Progression-Free Survival (PFS)
PFS is defined as the time from the day of randomization to the first evidence of progression as defined by RECIST (RECIST v1.1) criteria or death from any cause.
Time frame
Randomization to PD or Date of Death (Up to 21 Months)4
Plasma levels of CBX-12 (AUC0-24hr)
Assessment of pharmacokinetic (PK) variable AUC0-24hr
Time frame
At 1st dose of study drug (pre-dose, end of infusion (EOI), 1, 2, and 4 hours post EOI), and 10-14 days post 1st doseSponsors and contacts
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Source ClinicalTrials.gov