RECRUITING

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

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Conditions

Platinum-resistant Ovarian CancerRefractory Ovarian Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2024-08
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06315491

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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:
  2. * 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.
  3. * Patients who have progressed following a second course of a platinum based regimen.
  4. * 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.
  5. * Age greater than or equal to 18 years at the time of signing the informed consent form (ICF).
  6. * Has measurable disease per RECIST 1.1.
  7. * Has provided written informed consent.
  8. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  9. * Adequate liver, renal, hematologic, pulmonary and coagulation function.
  1. * Cytotoxic chemotherapy, biologic agent, investigational agent, or radiation therapy within 3 weeks prior to the first dose of CBX-12.
  2. * Subjects who are currently receiving any other anticancer or investigational agent(s).
  3. * Clinically significant intercurrent disease.
  4. * Active human immunodeficiency virus (HIV) infection.
  5. * Active hepatitis B or C infection.

Contacts and Locations

Study Contact

Clinical Operations Trial Team
CONTACT
860-717-2731
clinicalstudies@cybrexa.com

Principal Investigator

Michael Needle, MD
STUDY_DIRECTOR
Cybrexa Therapeutics

Study Locations (Sites)

D&H Cancer Research Center
Margate, Florida, 33063
United States
Women's Cancer Care
Covington, Louisiana, 70433
United States

Collaborators and Investigators

Sponsor: Cybrexa Therapeutics

  • Michael Needle, MD, STUDY_DIRECTOR, Cybrexa Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08
Study Completion Date2026-07

Study Record Updates

Study Start Date2024-08
Study Completion Date2026-07

Terms related to this study

Additional Relevant MeSH Terms

  • Platinum-resistant Ovarian Cancer
  • Refractory Ovarian Carcinoma