A Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer

Platinum-resistant Ovarian Cancer Clinical Trial

Official title:

A Randomized Phase 2 Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06315491
• Other study ID #: CBX-12-201
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 2024
• Est. completion date: April 2026

Study information

• Verified date: March 2024
• Source: Cybrexa Therapeutics
• Contact: Clinical Operations Trial Team
• Phone: 860-717-2731
• Email: clinicalstudies[@]cybrexa.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Neoplasms
• Platinum-resistant Ovarian Cancer
• Refractory Ovarian Carcinoma

Intervention

Drug:
• CBX-12
CBX-12 is an alphalex construct which contains exatecan as the pharmacologically active moiety.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cybrexa Therapeutics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Randomization to progressive disease (PD) (Up to approximately 21 months)
Secondary	Incidence of Subjects With Treatment Emergent Adverse Events (TEAEs)	Safety as assessed by the incidence of treatment-emergent AEs (TEAEs).	First dose of study drug to 30-day post-dose follow up (Up to approximately 21 months)
Secondary	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.	Date of Initial CR or PR to PD (Up to 21 Months)
Secondary	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.	Randomization to PD or Date of Death (Up to 21 Months)
Secondary	Plasma levels of CBX-12 (AUC0-24hr)	Assessment of pharmacokinetic (PK) variable AUC0-24hr	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
Secondary	Plasma levels of CBX-12 (Cmax)	Assessment of pharmacokinetic (PK) variable Cmax	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
Secondary	Plasma levels of CBX-12 (Tmax)	Assessment of pharmacokinetic (PK) variable Tmax	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
Secondary	Plasma levels of CBX-12 (T1/2)	Assessment of pharmacokinetic (PK) variable T1/2	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
Secondary	Plasma levels of Exatecan (AUC0-24hr)	Assessment of pharmacokinetic (PK) variable AUC0-24hr	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
Secondary	Plasma levels of Exatecan (Cmax)	Assessment of pharmacokinetic (PK) variable Cmax	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
Secondary	Plasma levels of Exatecan (Tmax)	Assessment of pharmacokinetic (PK) variable Tmax	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
Secondary	Plasma levels of Exatecan (T1/2)	Assessment of pharmacokinetic (PK) variable T1/2	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