A Study of Navicixizumab in Patients With Platinum Resistant Ovarian Cancer

NCT05043402 | Unknown Phase 3 DMC FDA Drug FDA Device

• 2 other identifiers: ONCX-NAV-G3012021-001933-38
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma

Keywords

Platinum-Resistant

Outcome Measures

Primary Outcomes (2)

• ORR

  Overall Response Rate defined as the proportion of patients with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR), by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

  Up to 2 years

• PFS

  Progression Free Survival

  Up to 2 years

Secondary Outcomes (4)

• OS

  Up to 2 years

• TTR

  Up to 2 years

• DCR

  Up to 2 years

• DOR

  Up to 2 years

Study Arms (3)

Combination navicixizumab + paclitaxel

EXPERIMENTAL

Combination navicixizumab + paclitaxel: navicixizumab 3 mg/kg Q2W of a 28 day cycle (i.e., Days 1 and 15); paclitaxel 80 mg/m2 on Days 1, 8 and 15 of a 28 day cycle

Drug: navicixizumab; Device: Xerna™ TME Panel

Paclitaxel monotherapy

ACTIVE COMPARATOR

Paclitaxel monotherapy: paclitaxel 80 mg/m2 on Days 1, 8 and 15 of a 28-day cycle

Device: Xerna™ TME Panel

Navicixizumab monotherapy

EXPERIMENTAL

Navicixizumab monotherapy: navicixizumab 3 mg/kg Q2W of a 28-day cycle (i.e., Days 1 and 15)

Drug: navicixizumab; Device: Xerna™ TME Panel

Interventions

navicixizumab DRUG

navicixizumab IV

Also known as: navi

Combination navicixizumab + paclitaxel; Navicixizumab monotherapy

Xerna™ TME Panel DEVICE

RNA-seq-based biomarker platform that classifies any given patient tumor sample into phenotypes based on the dominant biology of the tumor microenvironment (TME).

Combination navicixizumab + paclitaxel; Navicixizumab monotherapy; Paclitaxel monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OncXerna Theraputics, Inc.: lead

Related Publications (1)

• Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.

  PMID: 37185961 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

navicixizumab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Study Officials

• Kathleen N Moore, MD,MS

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

OncXerna Therapeutics

CONTACT

781-907-7810; medical@oncxerna.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 14, 2021
• Study Start: November 30, 2022
• Primary Completion: November 15, 2023
• Study Completion: August 15, 2024
• Last Updated: August 15, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share