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

Phase 2

Recruiting

• Conditions: Platinum-resistant Ovarian Cancer; Refractory Ovarian Carcinoma

• Registration Number: NCT06315491
• Lead Sponsor: Cybrexa Therapeutics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-3-7
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Inclusion Criteria:<br><br> - Subjects must have histologically- or cytologically-diagnosed epithelial high-grade<br> serous cancer of the ovary, fallopian tube cancer or primary peritoneum cancer that<br> is refractory to prior therapy and must have platinum-resistant disease defined as:<br><br> - Subjects who have received only 1 platinum-based chemotherapy regimen for at<br> least 4 cycles of platinum must have disease progression on treatment or<br> occurring = 26 weeks after their last dose of platinum.<br><br> - Patients who have progressed following a second course of a platinum based<br> regimen.<br><br> - Subjects may have up to 2 additional systemic regimens for advanced or<br> metastatic disease. Maintenance regimens (e.g., with a PARP inhibitor or<br> bevacizumab) are not considered separate regimens.<br><br> - Age greater than or equal to 18 years at the time of signing the informed consent<br> form (ICF).<br><br> - Has measurable disease per RECIST 1.1.<br><br> - Has provided written informed consent.<br><br> - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.<br><br> - Adequate liver, renal, hematologic, pulmonary and coagulation function.<br><br>Exclusion Criteria:<br><br> - Cytotoxic chemotherapy, biologic agent, investigational agent, or radiation therapy<br> within 3 weeks prior to the first dose of CBX-12.<br><br> - Subjects who are currently receiving any other anticancer or investigational<br> agent(s).<br><br> - Clinically significant intercurrent disease.<br><br> - Active human immunodeficiency virus (HIV) infection.<br><br> - Active hepatitis B or C infection.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]

Secondary Outcome Measures

Name	Time	Method
Incidence of Subjects With Treatment Emergent Adverse Events (TEAEs);Median Duration of Response (DoR);Progression-Free Survival (PFS);Plasma levels of CBX-12 (AUC0-24hr);Plasma levels of CBX-12 (Cmax);Plasma levels of CBX-12 (Tmax);Plasma levels of CBX-12 (T1/2);Plasma levels of Exatecan (AUC0-24hr);Plasma levels of Exatecan (Cmax);Plasma levels of Exatecan (Tmax);Plasma levels of Exatecan (T1/2)