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Recruiting NCT06315491

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

Phase II Interventional Platinum-resistant Ovarian Cancer Refractory Ovarian Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CBX-12.
Who it may be relevant to
Registry conditions: Platinum-resistant Ovarian Cancer, Refractory Ovarian Carcinoma. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • 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)]
Secondary outcome measures (11)
  • 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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 17 centers
  • Honor Health — Scottsdale
  • Arizona Oncology Associates — Tucson
  • Usc Norris Comprehensive Cancer Center — Los Angeles
  • Yale University School of Medicine — New Haven
  • D&H Cancer Research Center — Margate
  • South Florida Gynecology — Tampa
  • Northwest Cancer Centers — Dyer
  • Norton Cancer Institute — Louisville
  • … and 9 more centers

Identifiers

NCT: NCT06315491 · CBX-12-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗