Brief Summary
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.
Brief Title
A Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
860-717-2731
Central Contact Email
clinicalstudies@cybrexa.com
Completion Date
Completion Date Type
Estimated
Conditions
Platinum-resistant Ovarian Cancer
Refractory Ovarian Carcinoma
Eligibility 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.
* 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.
Inclusion 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.
* 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.
Gender
Female
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT06315491
Org Class
Industry
Org Full Name
Cybrexa Therapeutics
Org Study Id
CBX-12-201
Overall Status
Recruiting
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Randomized Phase 2 Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer
Primary Outcomes
Outcome Description
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.
Outcome Measure
Percentage of Subjects With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
Outcome Time Frame
Randomization to progressive disease (PD) (Up to approximately 21 months)
Secondary Outcomes
Outcome Description
Safety as assessed by the incidence of treatment-emergent AEs (TEAEs).
Outcome Time Frame
First dose of study drug to 30-day post-dose follow up (Up to approximately 21 months)
Outcome Measure
Incidence of Subjects With Treatment Emergent Adverse Events (TEAEs)
Outcome Description
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.
Outcome Time Frame
Date of Initial CR or PR to PD (Up to 21 Months)
Outcome Measure
Median Duration of Response (DoR)
Outcome Description
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.
Outcome Time Frame
Randomization to PD or Date of Death (Up to 21 Months)
Outcome Measure
Progression-Free Survival (PFS)
Outcome Description
Assessment of pharmacokinetic (PK) variable AUC0-24hr
Outcome 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 dose
Outcome Measure
Plasma levels of CBX-12 (AUC0-24hr)
Outcome Description
Assessment of pharmacokinetic (PK) variable Cmax
Outcome 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 dose
Outcome Measure
Plasma levels of CBX-12 (Cmax)
Outcome Description
Assessment of pharmacokinetic (PK) variable Tmax
Outcome 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 dose
Outcome Measure
Plasma levels of CBX-12 (Tmax)
Outcome Description
Assessment of pharmacokinetic (PK) variable T1/2
Outcome 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 dose
Outcome Measure
Plasma levels of CBX-12 (T1/2)
Outcome Description
Assessment of pharmacokinetic (PK) variable AUC0-24hr
Outcome Time Frame
At 1st dose of study drug (pre-dose, end of infusion (EOI), 1 hour post EOI, 2 hours post EOI, 4 hours post EOI), and 10-14 days post 1st dose
Outcome Measure
Plasma levels of Exatecan (AUC0-24hr)
Outcome Description
Assessment of pharmacokinetic (PK) variable Cmax
Outcome Time Frame
At 1st dose of study drug (pre-dose, end of infusion (EOI), 1 hour post EOI, 2 hours post EOI, 4 hours post EOI), and 10-14 days post 1st dose
Outcome Measure
Plasma levels of Exatecan (Cmax)
Outcome Description
Assessment of pharmacokinetic (PK) variable Tmax
Outcome Time Frame
At 1st dose of study drug (pre-dose, end of infusion (EOI), 1 hour post EOI, 2 hours post EOI, 4 hours post EOI), and 10-14 days post 1st dose
Outcome Measure
Plasma levels of Exatecan (Tmax)
Outcome Description
Assessment of pharmacokinetic (PK) variable T1/2
Outcome Time Frame
At 1st dose of study drug (pre-dose, end of infusion (EOI), 1 hour post EOI, 2 hours post EOI, 4 hours post EOI), and 10-14 days post 1st dose
Outcome Measure
Plasma levels of Exatecan (T1/2)
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Ken Lin
Investigator Email
kelin@montefiore.org