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)
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
navicixizumab 3 mg/kg Q2W; paclitaxel 80 mg/m2 weekly
navicixizumab 3 mg/kg Q2W; irinotecan 180 mg/m2 Q2W
navicixizumab 3 mg/kg Q2W
Genesis Cancer Center
Hot Springs, Arkansas, United States
RECRUITINGKeck Medicine of USC
Los Angeles, California, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
RECRUITINGNorthside Hospital
Atlanta, Georgia, United States
RECRUITINGHematology Oncology Clinic
Baton Rouge, Louisiana, United States
RECRUITINGNew York University - Langone Health - Perlmutter Cancer Center
New York, New York, United States
RECRUITINGThe Zangmeister Cancer Center
Columbus, Ohio, United States
RECRUITINGTennessee Oncology
Nashville, Tennessee, United States
RECRUITINGOverall Response Rate (ORR)
The proportion of patients with a confirmed best overall response (BOR) of complete response (CR) or PR by Response Evaluation Criteria in Solid Tumors, version 1.1 as determined by investigator tumor response assessments
Time frame: Up to 12 months
Progression Free Survival (PFS)
The time from first dose to the date of first documentation of objective disease progression or death (any cause), whichever occurs first, as determined by investigator tumor response assessments
Time frame: Up to 12 months
Adverse Events
Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0); clinical laboratory tests; vital sign measurements; electrocardiograms (ECGs); Doppler echocardiograms (ECHOs); physical examinations (PEs)
Time frame: Up to 12 months
Overall Survival (OS
Defined as the time from first dose to death
Time frame: Up to 18 months
Time to Response (TTR)
Defined as the time from first dose to first documentation of response (CR or PR)
Time frame: Up to 12 months
Disease control rate (DCR)
Defined as the proportion of patients with SD or a confirmed BOR of CR or PR
Time frame: Up to 12 months
Duration of Response (DOR)
Defined as the time from first documentation of response (CR or PR) to documentation of objective disease progression or death due to any cause, whichever occurs first
Time frame: Up to 18months
Xerna™ TME biomarker
Relationship between antitumor activity of navicixizumab therapy and Xerna™ TME Panel biomarker subtypes
Time frame: Up to 18 months
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