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NCT Number: NCT06315491

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

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.

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Key information

Conditions

Platinum-resistant Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Refractory Ovarian Carcinoma Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Honor Health, Scottsdale, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CBX-12

Drug

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

Primary outcomes

  1. 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)

    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.

Secondary outcomes

  1. 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)

    Safety as assessed by the incidence of treatment-emergent AEs (TEAEs).

  2. Median Duration of Response (DoR)

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

    Duration of response is the interval from the date of initial CR or PR until the first date criteria for PD is met using RECIST v1.1 criteria, or initiation of other (or additional) antitumor therapy is first reported, or death due to any cause.

  3. Progression-Free Survival (PFS)

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

    PFS is defined as the time from the day of randomization to the first evidence of progression as defined by RECIST (RECIST v1.1) criteria or death from any cause.

  4. 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

    Assessment of pharmacokinetic (PK) variable AUC0-24hr

  5. 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

    Assessment of pharmacokinetic (PK) variable Cmax

  6. 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

    Assessment of pharmacokinetic (PK) variable Tmax

  7. 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

    Assessment of pharmacokinetic (PK) variable T1/2

  8. 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

    Assessment of pharmacokinetic (PK) variable AUC0-24hr

  9. 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

    Assessment of pharmacokinetic (PK) variable Cmax

  10. 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

    Assessment of pharmacokinetic (PK) variable Tmax

  11. 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

    Assessment of pharmacokinetic (PK) variable T1/2

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Operations Trial Team

CONTACT

[email protected]

860-717-2731

Sponsors and collaborators

Lead sponsor

Cybrexa Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 18, 2024
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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