Actively Recruiting
Phase 2 Study of CBX-12 Treatment in Women 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
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 mgm2 and the other 100 mgm2 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
Research Team
C
Clinical Operations Trial Team
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