AVID100 in Advanced Epithelial Carcinomas
- Conditions
- Non Small Cell Lung CancerSolid Tumor, AdultTriple Negative Breast CancerHead and Neck Squamous Cell Carcinoma
- Interventions
- Drug: AVID100 IV
- Registration Number
- NCT03094169
- Lead Sponsor
- Formation Biologics
- Brief Summary
Approximately 90 male and female patients with documented solid tumor malignancies of epithelial origin that are locally advanced or metastatic, and either refractory to standard therapy or for whom no standard therapy is available, will be entered into this Phase 1a/2a, multicenter, open-label, dose-escalation, cohort study of AVID100. Phase 2a will include evaluation of patient with EGFR-overexpressing squamous histology non-small cell lung cancer, squamous cell carcinoma of the head and neck, and triple negative breast cancer
- Detailed Description
On Day 1 of study, patients will receive study drug administered by 2-hour IV infusion. AVID100 will be administered once every 3 weeks (Q3W) with administration on Day 1 of the first week, followed by a 3-week recovery period. In Phase 2a AVID100 will be administered at a dose of 220 mg/m2.
Evidence of progressive disease at any point in the study will necessitate withdrawal of the patient from further participation so that alternative management of their malignancy may be considered. All patients will be followed to further evaluate safety as well as evidence of the anti-tumor effects of AVID100 in these selected patient populations. If anti-tumor activity is observed additional patients may be added to the planned Phase 2a patient populations to further characterize these effects.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 49
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dose escalation AVID100 IV Minimum of 1 to 3 patients per dose cohort; approximately 4 dose cohorts to be evaluated to establish the Maximum tolerated dose. Phase 2a Triple Negative Breast Cancer AVID100 IV Addition of up to 15 patients in each of 2 subpopulations of patients with triple negative breast cancer (30 total). One group of 15 patients will have 3+ EGFR over-expression. The second group will have 2+ EGFR over-expression. Phase 2a Head and Neck Carcinoma AVID100 IV Addition of 15 patients with squamous head and neck carcinoma. Patients will have 3+ EGFR over-expression. Phase 2a Non-Small Cell Lung Carcinoma AVID100 IV Addition of 15 patients with squamous histology non-small cell lung carcinoma. Patients will have 3+ EGFR over-expression
- Primary Outcome Measures
Name Time Method Phase 1a: Determine safety and tolerability of AVID100 6 months Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Phase 2a: Evaluation of the preliminary antineoplastic effects of AVID100 18 months Number of participants with objective response or stable disease
- Secondary Outcome Measures
Name Time Method PK Profile of Total Antibody 18 months Characterization of the pharmacokinetic profile of total antibody
Trial Locations
- Locations (10)
Texas Oncology Midtown
🇺🇸Austin, Texas, United States
The Tisch Cancer Institute-Mt. Sinai
🇺🇸New York, New York, United States
Texas Oncology Tyler
🇺🇸Tyler, Texas, United States
START Midwest
🇺🇸Grand Rapids, Michigan, United States
Yale
🇺🇸New Haven, Connecticut, United States
Fox Chase
🇺🇸Philadelphia, Pennsylvania, United States
Texas Oncology McAllen
🇺🇸McAllen, Texas, United States
Texas Oncology-Baylor -Charles A. Sammons Cancer Center
🇺🇸Dallas, Texas, United States
Texas Oncology NE San Antonio
🇺🇸San Antonio, Texas, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States