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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Cybrexa Therapeutics
Study ID
NCT06315491
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 25, 2024
Status verified
Oct 2025
Primary completion
Oct 31, 2025
Completion
Oct 31, 2025

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (17)

FacilityCityStateZIPSite coordinators
Honor HealthScottsdaleArizona85260-
Arizona Oncology AssociatesTucsonArizona85711-
Usc Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Yale University School of MedicineNew HavenConnecticut06510-
D&H Cancer Research CenterMargateFlorida33063-
South Florida GynecologyTampaFlorida33606-
Northwest Cancer CentersDyerIndiana46311-
Norton Cancer InstituteLouisvilleKentucky40202-
Women's Cancer CareCovingtonLouisiana70433-
Albert Einstein College of Medicine Montefiore MedicalNew YorkNew York10021-
Pci Nyu Langone HealthNew YorkNew York10016-
University Hospitals Seidman Cancer CenterClevelandOhio44106-
Oncology Associates of OregonEugeneOregon97401-
Allegheny Singer Research Institute D/B/A Ahn Research InstitutionPittsburghPennsylvania15212
Shannon Buono
412-578-4216
Mary Crowley Cancer ResearchDallasTexas75251
Cristina Laviada
972-566-3044
Texas Oncology- Gulf CoastThe WoodlandsTexas77380-
Multicare Institute For Research & InnovationTacomaWashington98405-

Find similar trials in Scottsdale, AZ

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Honor Health· Scottsdale, AZArizona Oncology Associates· Tucson, AZUsc Norris Comprehensive Cancer Center· Los Angeles, CAYale University School of Medicine· New Haven, CTD&H Cancer Research Center· Margate, FLSouth Florida Gynecology· Tampa, FL

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