Actively Recruiting
A Randomized Phase 2 Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer
Led by Cybrexa Therapeutics · Updated on 2025-10-06
40
Participants Needed
17
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating CBX-12, a drug containing exatecan, in female patients with ovarian cancer that is resistant or refractory to platinum-based chemotherapy. The study aims to assess the safety, tolerability, and effectiveness of two different doses of CBX-12 given every 21 days. This is a Phase 2 randomized study focused on women with high-grade serous ovarian, fallopian tube, or primary peritoneal cancer who have limited treatment options due to disease progression. Participants receive CBX-12 through intravenous infusions in two groups: one receiving 125 mg/m2 and the other 100 mg/m2 every 21 days. Treatment continues until the cancer shows progression or unacceptable side effects occur. The study carefully monitors both doses to compare their outcomes and side effects. During the study, participants will have regular evaluations including scans to measure tumor response, blood tests to check drug levels and organ function, and monitoring for any adverse effects. The main outcome is the rate of tumor response, with additional measures including side effects, duration of response, and progression-free survival over approximately 21 months. Safety follow-up continues for 30 days after the last dose, ensuring thorough observation of participants throughout the trial period.
CONDITIONS
Brief Title
A Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female subjects aged 18 years or older
- Histologically or cytologically confirmed epithelial high-grade serous ovarian, fallopian tube, or primary peritoneal cancer
- Platinum-resistant or refractory disease as defined by progression during or within 26 weeks after platinum chemotherapy
- May have received up to two additional systemic treatments for advanced disease excluding maintenance therapies
- Measurable disease according to RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate liver, kidney, blood, lung, and coagulation function
- Provided written informed consent
You will not qualify if you...
- Received cytotoxic chemotherapy, biologic agents, investigational agents, or radiation therapy within 3 weeks before first dose of CBX-12
- Currently receiving other anticancer or investigational treatments
- Presence of clinically significant intercurrent diseases
- Active human immunodeficiency virus (HIV) infection
- Active hepatitis B or C infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 21 months
Participants receive CBX-12 by intravenous infusion every 21 days until disease progression or unacceptable toxicity occurs.
Visits every 3 weeks for drug administration
Duration - 30 days post last dose
Participants are monitored for safety and treatment outcomes after completing treatment.
1 follow-up visit
Trial Site Locations
Total: 17 locations
1
Honor Health
Scottsdale, Arizona, United States, 85260
Withdrawn
2
Arizona Oncology Associates
Tucson, Arizona, United States, 85711
Active, Not Recruiting
3
Usc Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Active, Not Recruiting
4
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Active, Not Recruiting
5
D&H Cancer Research Center
Margate, Florida, United States, 33063
Active, Not Recruiting
6
South Florida Gynecology
Tampa, Florida, United States, 33606
Active, Not Recruiting
7
Northwest Cancer Centers
Dyer, Indiana, United States, 46311
Withdrawn
8
Norton Cancer Institute
Louisville, Kentucky, United States, 40202
Active, Not Recruiting
9
Women's Cancer Care
Covington, Louisiana, United States, 70433
Active, Not Recruiting
10
Pci Nyu Langone Health
New York, New York, United States, 10016
Active, Not Recruiting
11
Albert Einstein College of Medicine Montefiore Medical
New York, New York, United States, 10021
Active, Not Recruiting
12
University Hospitals Seidman Cancer Center
Cleveland, Ohio, United States, 44106
Active, Not Recruiting
13
Oncology Associates of Oregon
Eugene, Oregon, United States, 97401
Active, Not Recruiting
14
Allegheny Singer Research Institute D/B/A Ahn Research Institution
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
15
Mary Crowley Cancer Research
Dallas, Texas, United States, 75251
Actively Recruiting
16
Texas Oncology- Gulf Coast
The Woodlands, Texas, United States, 77380
Active, Not Recruiting
17
Multicare Institute For Research & Innovation
Tacoma, Washington, United States, 98405
Active, Not Recruiting
Research Team
C
Clinical Operations Trial Team
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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