NCT05453825

A Study of Navicixizumab Monotherapy or in Combination in Patients With Select Advanced Solid Tumors

A Phase 2, Multicenter, Open-Label Basket Study of Navicixizumab Monotherapy or in Combination With Paclitaxel or Irinotecan in Patients With Select Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: OncXerna Theraputics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study of navicixizumab monotherapy or in combination with paclitaxel or irinotecan in patients with advanced cancer. Patients will be enrolled into one of the following cancer cohorts: * Cohort A: CRC * Cohort B: Gastric and GEJ cancer * Cohort C: TNBC * Cohort D: Platinum-resistant/refractory epithelial ovarian, primary peritoneal, or fallopian tube cancer (ovarian cancer)

Detailed description

After completing all screening procedures, including the submission of a tissue sample, patients that meet eligibility requirements will be assigned to receive navicixizumab alone or in combination with another anticancer agent. Treatment is assigned based on the patients type of tumor and the cohort that is open at the time of enrollment. Patients will receive treatment in 4 week cycles, attend study visits and have their heart monitored through echocardiograms and daily blood pressure measurements. Patients will also have their tumors monitored regularly through CT scans. Patients receiving benefit may continue on study drug until their tumor progresses, they experience intolerable side effects, their physician decides it is in their best interest to discontinue therapy or they choose to withdrawal from the study. After discontinuing study treatments, all patients will receive regular follow up calls or visits to assess their status and other anticancer treatments they may start.

Conditions

• Colorectal Cancer
• Triple Negative Breast Cancer
• Gastric Cancer
• Ovarian Cancer

Interventions

Type	Name	Description
BIOLOGICAL	navicixizumab+paclitaxel	navicixizumab 3 mg/kg Q2W; paclitaxel 80 mg/m2 weekly
BIOLOGICAL	navicixizumab+irinotecan	navicixizumab 3 mg/kg Q2W; irinotecan 180 mg/m2 Q2W
BIOLOGICAL	navicixizumab monotherapy	navicixizumab 3 mg/kg Q2W

Timeline

• Start date: 2022-08-05
• Primary completion: 2024-04-15
• Completion: 2024-12-15
• First posted: 2022-07-12
• Last updated: 2023-01-31

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study