Combination navicixizumab + paclitaxel for Triple Negative Breast Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Hematology Oncology Clinic, Baton Rouge, LA
Triple Negative Breast Neoplasms+4 More
navicixizumab+paclitaxel - Biological
Eligibility
18+
All Sexes
What conditions do you have?
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Study 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)

Eligible Conditions

  • Triple Negative Breast Neoplasms
  • Malignant Neoplasm of Stomach
  • Ovarian Cancer
  • Colorectal Carcinoma (CRC)
  • Breast Cancer (Triple Negative Breast Cancer (TNBC))

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Triple Negative Breast Neoplasms

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: Up to 18months

Up to 12 months
Adverse Events
Cancer antigen-125 response
Disease control rate (DCR)
Overall Response Rate (ORR)
Progression Free Survival (PFS)
Time to Response (TTR)
Up to 18 months
Overall Survival (OS
Xerna™ TME biomarker
Up to 18months
Duration of Response (DOR)
Up to 6 months
Immunogenicity
Navicixizumab Pharmacokinetics

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Triple Negative Breast Neoplasms

Trial Design

3 Treatment Groups

Combination navicixizumab + paclitaxel
1 of 3
Navicixizumab monotherapy
1 of 3
Combination navicixizumab + irinotecan
1 of 3
Experimental Treatment

180 Total Participants · 3 Treatment Groups

Primary Treatment: Combination navicixizumab + paclitaxel · No Placebo Group · Phase 2

Combination navicixizumab + paclitaxel
Biological
Experimental Group · 1 Intervention: navicixizumab+paclitaxel · Intervention Types: Biological
Navicixizumab monotherapy
Biological
Experimental Group · 1 Intervention: navicixizumab monotherapy · Intervention Types: Biological
Combination navicixizumab + irinotecan
Biological
Experimental Group · 1 Intervention: navicixizumab+irinotecan · Intervention Types: Biological

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 18months
Closest Location: Hematology Oncology Clinic · Baton Rouge, LA
2005First Recorded Clinical Trial
2 TrialsResearching Triple Negative Breast Neoplasms
6 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
You have measurable disease, as defined by RECIST v1.1.
You are 18 years old or older.\n
You must have had a gastric or GEJ cancer.
You have platinum-resistant/refractory epithelial ovarian, primary peritoneal, or fallopian tube cancer.
Patient has provided an FFPE archive or newly obtained core or excisional biopsy of a tumor lesion.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.