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Not recruiting
Phase 2

CBX 12

Sponsor:

Cybrexa Therapeutics

Code:

NCT06315491

Conditions

Platinum-resistant Ovarian Cancer

Refractory Ovarian Carcinoma

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CBX-12

Study Details

Brief 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.

Conditions

Platinum-resistant Ovarian Cancer

Refractory Ovarian Carcinoma

Study ID

NCT06315491

Start date

Sep 25, 2024

Status verified date

Aug, 2026

Completion date

Oct 31, 2025

Primary completion date

Oct 31, 2025

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CBX-12 - 125mg/m2 q21d

125mg/m2 CBX-12 administered by intravenous (IV) infusion every 21 days. Treatment will continue until there is evidence of progressive disease (PD) or development of unacceptable toxicity.

experimental: CBX-12 - 100mg/m2 q21d

100mg/m2 CBX-12 administered by intravenous (IV) infusion every 21 days. Treatment will continue until there is evidence of progressive disease (PD) or development of unacceptable toxicity.

Interventions

CBX-12

CBX-12 is an alphalex construct which contains exatecan as the pharmacologically active moiety.

Primary outcome measure

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

Central Contacts and Locations

More Information

Sponsor

Cybrexa Therapeutics

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-21. This information was provided to ClinicalTrials.gov by Cybrexa Therapeutics on 2026-08-20.