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

Description

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.

Conditions

Platinum-resistant Ovarian Cancer, Refractory Ovarian Carcinoma

Study Overview

Study Details

Study 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.

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

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

Condition
Platinum-resistant Ovarian Cancer
Intervention / Treatment

-

Contacts and Locations

Margate

D&H Cancer Research Center, Margate, Florida, United States, 33063

Covington

Women's Cancer Care, Covington, Louisiana, United States, 70433

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cybrexa Therapeutics,

Michael Needle, MD, STUDY_DIRECTOR, Cybrexa Therapeutics

Study Record Dates

2026-07