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A Study of CBX-12 for Platinum-Resistant Ovarian Cancer

This study is testing a drug called CBX-12 in women with ovarian, fallopian tube, or primary peritoneum cancer that has become resistant to platinum-based chemotherapy. CBX-12 contains a component called exatecan. The main goal is to see how many participants experience a complete or partial shrinking of their cancer (Objective Response Rate). Researchers will also look at the safety and how well CBX-12 is tolerated at two different doses (125 mg/m2 or 100 mg/m2, given every 21 days). The study plans to enroll 40 women aged 18 or older who meet specific criteria for platinum-resistant disease. The current recruitment status is unclear.

Study design
This study is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 40 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from randomization until their disease progresses, for up to approximately 21 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06315491

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

Terminated
PHASE2Ages 18+InterventionalTreatment
Cybrexa Therapeutics
~40 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:CBX-12

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Subjects With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
Measured over Randomization to progressive disease (PD) (Up to approximately 21 months)

Conditions

Platinum-resistant Ovarian Cancer
Refractory Ovarian Carcinoma

Explore related trials

Fallopian Tube CarcinomaMalignant Ovarian NeoplasmPrimary Peritoneum Cancer

Where it's being run

1 sites across 1 states
Arizona1

Study leadership

  • Michael Needle, MD · STUDY_DIRECTOR · Cybrexa Therapeutics

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Percentage of Subjects With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]Randomization to progressive disease (PD) (Up to approximately 21 months)

    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.