Clinical trial NCT06315491: A Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer
Official title: A Randomized Phase 2 Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Platinum-resistant Ovarian Cancer
Refractory Ovarian Carcinoma
Lead sponsor: Cybrexa Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-03-18
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Subjects With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
timeFrame: Randomization to progressive disease (PD) (Up to approximately 21 months)
Secondary outcomes:
measure: Incidence of Subjects With Treatment Emergent Adverse Events (TEAEs)
timeFrame: First dose of study drug to 30-day post-dose follow up (Up to approximately 21 months)
measure: Median Duration of Response (DoR)
timeFrame: Date of Initial CR or PR to PD (Up to 21 Months)
measure: Progression-Free Survival (PFS)
timeFrame: Randomization to PD or Date of Death (Up to 21 Months)
measure: Plasma levels of CBX-12 (AUC0-24hr)
timeFrame: 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
measure: Plasma levels of CBX-12 (Cmax)
timeFrame: 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
measure: Plasma levels of CBX-12 (Tmax)
timeFrame: 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
measure: Plasma levels of CBX-12 (T1/2)
timeFrame: 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
measure: Plasma levels of Exatecan (AUC0-24hr)
timeFrame: 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
measure: Plasma levels of Exatecan (Cmax)
timeFrame: 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
measure: Plasma levels of Exatecan (Tmax)
timeFrame: 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
measure: Plasma levels of Exatecan (T1/2)
timeFrame: 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
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Honor Health
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates
state: Arizona
city: Los Angeles
country: United States
facility: Usc Norris Comprehensive Cancer Center
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Margate
country: United States
facility: D&H Cancer Research Center
state: Florida
city: Tampa
country: United States
facility: South Florida Gynecology
state: Florida
city: Dyer
country: United States
facility: Northwest Cancer Centers
state: Indiana
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Covington
country: United States
facility: Women's Cancer Care
state: Louisiana
city: New York
country: United States
facility: Pci Nyu Langone Health
state: New York
city: New York
country: United States
facility: Albert Einstein College of Medicine Montefiore Medical
state: New York
city: Cleveland
country: United States
facility: University Hospitals Seidman Cancer Center
state: Ohio
city: Eugene
country: United States
facility: Oncology Associate or Oregon
state: Oregon
city: Philadelphia
country: United States
facility: Sidney Kimmel Medical College at Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Singer Research Institute D/B/A Ahn Research Institution
state: Pennsylvania
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
city: Dallas
country: United States
facility: Mary Crowley Cancer Research
state: Texas
city: The Woodlands
country: United States
facility: Texas Oncology- Gulf Coast
state: Texas
city: Fairfax
country: United States
facility: Virgina Cancer Specialist
state: Virginia
city: Tacoma
country: United States
facility: Multicare Institute For Research & Innovation
state: Washington
Study officials:
affiliation: Cybrexa Therapeutics
name: Michael Needle, MD
role: STUDY_DIRECTOR
References: