A Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer
NCT ID: NCT06315491
Last Updated: 2025-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2024-09-25
2025-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
CBX-12
CBX-12 is an alphalex construct which contains exatecan as the pharmacologically active moiety.
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.
CBX-12
CBX-12 is an alphalex construct which contains exatecan as the pharmacologically active moiety.
Interventions
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CBX-12
CBX-12 is an alphalex construct which contains exatecan as the pharmacologically active moiety.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Cybrexa Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Needle, MD
Role: STUDY_DIRECTOR
Cybrexa Therapeutics
Locations
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Honor Health
Scottsdale, Arizona, United States
Arizona Oncology Associates
Tucson, Arizona, United States
Usc Norris Comprehensive Cancer Center
Los Angeles, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
D&H Cancer Research Center
Margate, Florida, United States
South Florida Gynecology
Tampa, Florida, United States
Northwest Cancer Centers
Dyer, Indiana, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Women's Cancer Care
Covington, Louisiana, United States
Pci Nyu Langone Health
New York, New York, United States
Albert Einstein College of Medicine Montefiore Medical
New York, New York, United States
University Hospitals Seidman Cancer Center
Cleveland, Ohio, United States
Oncology Associates of Oregon
Eugene, Oregon, United States
Allegheny Singer Research Institute D/B/A Ahn Research Institution
Pittsburgh, Pennsylvania, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
Texas Oncology- Gulf Coast
The Woodlands, Texas, United States
Multicare Institute For Research & Innovation
Tacoma, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Shannon Buono
Role: primary
Cristina Laviada
Role: primary
Other Identifiers
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CBX-12-201
Identifier Type: -
Identifier Source: org_study_id
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