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

Sponsor: Cybrexa Therapeutics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06315491

Patient View

This study evaluates the safety, tolerability, and efficacy of CBX-12, an alphalex construct with exatecan, in women with platinum-resistant or refractory ovarian cancer. Eligible participants must have high-grade serous cancer, be 18 or older, have measurable disease, and meet specific health criteria. The trial involves two dosing regimens administered every 21 days.

Patient Parameters

Program Overview

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

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.

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