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
1 other identifier
interventional
180
1 country
8
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 colorectal-cancer
Started Aug 2022
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2022
CompletedFirst Posted
Study publicly available on registry
July 12, 2022
CompletedStudy Start
First participant enrolled
August 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2024
CompletedJanuary 31, 2023
January 1, 2023
1.7 years
July 7, 2022
January 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Overall 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
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
Up to 12 months
Secondary Outcomes (6)
Adverse Events
Up to 12 months
Overall Survival (OS
Up to 18 months
Time to Response (TTR)
Up to 12 months
Disease control rate (DCR)
Up to 12 months
Duration of Response (DOR)
Up to 18months
- +1 more secondary outcomes
Other Outcomes (3)
Cancer antigen-125 response
Up to 12 months
Immunogenicity
Up to 6 months
Navicixizumab Pharmacokinetics
Up to 6 months
Study Arms (3)
Combination navicixizumab + paclitaxel
EXPERIMENTALGastric/GEJ and TNBC cancer patients will be assigned to this treatment arm.
Combination navicixizumab + irinotecan
EXPERIMENTALCRC patients will be assigned to this treatment arm.
Navicixizumab monotherapy
EXPERIMENTALCRC,TNBC and ovarian cancer patients will be assigned to this treatment arm.
Interventions
navicixizumab 3 mg/kg Q2W; paclitaxel 80 mg/m2 weekly
navicixizumab 3 mg/kg Q2W; irinotecan 180 mg/m2 Q2W
Eligibility Criteria
You may qualify if:
- Patient provides informed consent.
- Patient is ≥18 years old.
- Patient has one of the following locally advanced or metastatic, unresectable solid malignancies that is incurable:
- CRC
- Gastric or GEJ cancer
- TNBC
- 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.
- Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Patient has measurable disease, as defined by RECIST v1.1.
- Patient has adequate organ function.
- Female patients of childbearing potential must have a negative pregnancy test.
- Female patients of childbearing potential must agree to follow instructions for highly effective method(s) of contraception while receiving study treatment and for 6 months after the last dose of study drug.
- Male patients with female sexual partners of childbearing potential must agree to use an acceptable form of contraception while receiving study treatment and for 6 months after the last dose of any study drug.
- Patient is willing and able to comply with scheduled visits and procedures.
- +14 more criteria
You may not qualify if:
- Patient has cardiac conditions as listed in the protocol.
- Patient has blood pressure (BP) \>140/90 mmHg.
- Patient is pregnant or lactating.
- Patient has known untreated, active or uncontrolled brain metastases.
- Patient with leptomeningeal disease.
- Patient has a known additional malignancy that was progressing or required active treatment within 2 years prior to the first dose of study medication.
- Patient has a history of bowel obstruction, including sub-occlusive disease, related to the underlying disease or history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess.
- Patient has an active infection requiring IV systemic therapy.
- Patient has known hypersensitivity to any components of any study drug or any of its excipients that, in the opinion of the investigator, suggests a high risk for a severe hypersensitivity reaction while on treatment.
- Patient has a known clinically significant bleeding disorder.
- Patient is currently using oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes for which the dose has not been stable for \>14 days prior to C1D1.
- Patient had hemoptysis \>2.5 mL within 8 weeks prior to C1D1 or serious bleeding from another site within this time frame.
- Patient had a major surgical procedure, or significant traumatic injury within 28 days prior to C1D1.
- Patient has an uncontrolled seizure disorder or active neurologic disease.
- Patient has a cardiac aneurysm.
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Genesis Cancer Center
Hot Springs, Arkansas, 71913, United States
Keck Medicine of USC
Los Angeles, California, 90033, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Northside Hospital
Atlanta, Georgia, 30322, United States
Hematology Oncology Clinic
Baton Rouge, Louisiana, 70809, United States
New York University - Langone Health - Perlmutter Cancer Center
New York, New York, 10016, United States
The Zangmeister Cancer Center
Columbus, Ohio, 43219, United States
Tennessee Oncology
Nashville, Tennessee, 37203, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2022
First Posted
July 12, 2022
Study Start
August 5, 2022
Primary Completion
April 15, 2024
Study Completion
December 15, 2024
Last Updated
January 31, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share