A Study of Navicixizumab in Patients With Platinum Resistant Ovarian Cancer

• Status: Not yet recruiting
• Trial end date: 2024-08-15
• Target enrollment: 0
• Participant gender: Female

Summary

This is a Phase 3, randomized, open-label, 2-stage, multicenter study of navicixizumab with or without paclitaxel compared with paclitaxel monotherapy in patients with platinum-resistant advanced epithelial ovarian cancer and specific biomarkers, as measured by the proprietary and validated Xerna™ TME Panel biomarker assay. Eligible patients must have received at least 2 prior regimens but not more than 5 prior regimens, including treatment with a monoclonal antibody angiogenesis inhibitor (e.g., bevacizumab), must be considered platinum-resistant, and must be considered appropriate to receive single-agent paclitaxel chemotherapy as a next line of therapy. All patients must be willing and able to provide a formalin-fixed paraffin embedded (FFPE) archive or core tumor sample collected during screening for classification as B+ or B- biomarker status based on RNA expression data from the Xerna™ TME Panel biomarker assay. The co-primary efficacy endpoints are ORR by RECIST v1.1 and PFS (as assessed by blinded independent radiological review [BIRR]) analyzed at different timepoints. Analysis of the ORR primary efficacy endpoints will occur at the end of Stage 1 and at the end of Stage 2; the PFS primary efficacy endpoint will be analyzed at the end of Stage 2.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OncXerna Theraputics, Inc.

Criteria

Inclusion Criteria:

• Patient must have epithelial ovarian, fallopian tube, or primary peritoneal cancer

• Patients must have received ≥2 and not more than 5 prior therapies, including at least 1 line of therapy containing bevacizumab (or biosimilar).

• Patients must be considered platinum-resistant, defined as progression within 6 months from completion of a platinum-containing therapy

• Patient must be considered appropriate for treatment with weekly paclitaxel monotherapy as the next line of therapy.

• Patient must be willing and able to provide an FFPE archival or core tumor sample for determination of biomarker status on the Xerna™ TME Panel biomarker assay (positive or negative) prior to study treatment.

• Presence of at least one measurable lesion, as defined by RECIST v1.1.

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 Adequate organ function

Exclusion Criteria:

• Non-epithelial ovarian carcinoma.

• Ovarian tumors with low malignant potential (i.e., borderline tumors).

• Primary platinum-refractory disease (defined as progression during or within 4 weeks after completion of the first platinum regimen).

• Patient has received an anti-angiogenic product other than bevacizumab or biosimilar.

• Patient has congestive heart failure

• Patient has a history of myocardial infarction, cerebral vascular accident, or transient ischemic attacks within 6 months

• Patient has a history of cardiac ischemia or heart failure within 6 months

• Baseline B-type natriuretic peptide (BNP) value >100 pg/mL or N-terminal-proBNP (NT-proBNP) value of > 125 pg/mL.

• LVEF <50%.

• Peak tricuspid velocity >3.0 m/s on Doppler ECHO.

• Clinically significant ECG abnormality, as assessed by the investigator

• Blood pressure (BP) >140/90 mmHg

• History of bowel obstruction, including sub-occlusive disease, related to the underlying disease

• Hemoptysis >2.5 mL within 8 weeks prior

• Major surgical procedure, or significant traumatic injury within 28 days

• Uncontrolled seizure disorder or active neurologic disease

• Patients with a cardiac aneurysm.