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.

Age: 18 Years and older

Gender: Female

Start Date: 09/25/2024

Primary Completion Date (Estimated): 10/01/2025

Study Completion Date (Estimated): 10/01/2025

Accepts Healthy Volunteers: No

Trial Purpose and Description

Eligibility Criteria

Age: 18 Years and older

Gender: Female

Accepts Healthy Volunteers: No

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.