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RecruitingInterventionalPhase 2

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

NCT ID: NCT06315491Sponsor: Cybrexa TherapeuticsLast updated: 2025-10-06

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.

Arms & interventions

  • DrugCBX-12

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

Outcome measures

Primary

  • Percentage of Subjects With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]

    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.

    Time frame: Randomization to progressive disease (PD) (Up to approximately 21 months)

Secondary

  • Incidence of Subjects With Treatment Emergent Adverse Events (TEAEs)

    Time frame: First dose of study drug to 30-day post-dose follow up (Up to approximately 21 months)

  • Median Duration of Response (DoR)

    Time frame: Date of Initial CR or PR to PD (Up to 21 Months)

  • Progression-Free Survival (PFS)

    Time frame: Randomization to PD or Date of Death (Up to 21 Months)

  • Plasma levels of CBX-12 (AUC0-24hr)

    Time frame: At 1st dose of study drug (pre-dose, end of infusion (EOI), 1, 2, and 4 hours post EOI), and 10-14 days post 1st dose

  • Plasma levels of CBX-12 (Cmax)

    Time frame: At 1st dose of study drug (pre-dose, end of infusion (EOI), 1, 2, and 4 hours post EOI), and 10-14 days post 1st dose

  • Plasma levels of CBX-12 (Tmax)

    Time frame: At 1st dose of study drug (pre-dose, end of infusion (EOI), 1, 2, and 4 hours post EOI), and 10-14 days post 1st dose

  • Plasma levels of CBX-12 (T1/2)

    Time frame: At 1st dose of study drug (pre-dose, end of infusion (EOI), 1, 2, and 4 hours post EOI), and 10-14 days post 1st dose

  • Plasma levels of Exatecan (AUC0-24hr)

    Time frame: At 1st dose of study drug (pre-dose, end of infusion (EOI), 1 hour post EOI, 2 hours post EOI, 4 hours post EOI), and 10-14 days post 1st dose

  • Plasma levels of Exatecan (Cmax)

    Time frame: At 1st dose of study drug (pre-dose, end of infusion (EOI), 1 hour post EOI, 2 hours post EOI, 4 hours post EOI), and 10-14 days post 1st dose

  • Plasma levels of Exatecan (Tmax)

    Time frame: At 1st dose of study drug (pre-dose, end of infusion (EOI), 1 hour post EOI, 2 hours post EOI, 4 hours post EOI), and 10-14 days post 1st dose

  • Plasma levels of Exatecan (T1/2)

    Time frame: At 1st dose of study drug (pre-dose, end of infusion (EOI), 1 hour post EOI, 2 hours post EOI, 4 hours post EOI), and 10-14 days post 1st dose

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No
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 locations (17)

Honor Health

Scottsdale, Arizona, 85260

Withdrawn

Arizona Oncology Associates

Tucson, Arizona, 85711

Active Not Recruiting

Usc Norris Comprehensive Cancer Center

Los Angeles, California, 90033

Active Not Recruiting

Yale University School of Medicine

New Haven, Connecticut, 06510

Active Not Recruiting

D&H Cancer Research Center

Margate, Florida, 33063

Active Not Recruiting

South Florida Gynecology

Tampa, Florida, 33606

Active Not Recruiting

Northwest Cancer Centers

Dyer, Indiana, 46311

Withdrawn

Norton Cancer Institute

Louisville, Kentucky, 40202

Active Not Recruiting

Women's Cancer Care

Covington, Louisiana, 70433

Active Not Recruiting

Pci Nyu Langone Health

New York, New York, 10016

Active Not Recruiting

Albert Einstein College of Medicine Montefiore Medical

New York, New York, 10021

Active Not Recruiting

University Hospitals Seidman Cancer Center

Cleveland, Ohio, 44106

Active Not Recruiting

Oncology Associates of Oregon

Eugene, Oregon, 97401

Active Not Recruiting

Allegheny Singer Research Institute D/B/A Ahn Research Institution

Pittsburgh, Pennsylvania, 15212

Recruiting
Shannon Buono · Contact
412-578-4216

Mary Crowley Cancer Research

Dallas, Texas, 75251

Recruiting
Cristina Laviada · Contact
972-566-3044

Texas Oncology- Gulf Coast

The Woodlands, Texas, 77380

Active Not Recruiting

Multicare Institute For Research & Innovation

Tacoma, Washington, 98405

Active Not Recruiting