A Study of ABT-806 in Subjects With Advanced Solid Tumor Types
- Registration Number
- NCT01255657
- Lead Sponsor
- AbbVie (prior sponsor, Abbott)
- Brief Summary
This is an open-label study designed to determine the recommended Phase 2 dose (RPTD) and evaluate the safety and pharmacokinetics of ABT-806 in subjects with advanced solid tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
Inclusion Criteria
- Subject has a solid tumor of a type known to either over-express wild-type EGFR or to express variant III mutant EGFR (e.g., head and neck squamous cell carcinoma, non small cell lung cancer (NSCLC), colorectal carcinoma) or a tumor known to be EGFR positive.
- Subject must have disease that is not amenable to surgical resection or other approved therapeutic options with curative intent.
- Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
- Subject must have measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
- Inclusion criteria for Expand Safety Cohort B - subject has histologically confirmed supratentorial glioblastoma multiforme (GBM) .
Exclusion Criteria
- Subject has uncontrolled metastases to the central nervous system. Subjects with brain metastases are eligible provided they have shown clinical and radiographic stable disease for at least 1 month after definitive therapy. Subjects with glioblastoma multiforme (GBM) are excluded from the dose escalation portion of the study, but may be enrolled in the expanded safety cohort.
- Subject has received anticancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy within a period of 21 days prior to the first dose of ABT-806.
- Subject has had any adjustments of an ongoing steroid medication during the 14 days prior to the first dose of ABT-806.
- Subject has received a prior EGFR-directed monoclonal antibody within a period of 4 weeks prior to the first dose of ABT-806.
- Subject has unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ABT-806 Arm ABT-806 -
- Primary Outcome Measures
Name Time Method Pharmacokinetic profile (assay for ABT-806) Dose Escalation Cohort Week 1, 2, 3, 5, 7, 8, 9, 11, 13, 15, 19, 23 and Final Visit Assay for ABT-806
Pharmacokinetic profile (assay for ABT-806) Expanded Safety Cohort Week 1, 3, 5, 7, 11, 13, 15, 19, 23 and 30 Day Follow-up Assay for ABT-806
Safety (Number of subjects with adverse events and/or dose-limiting toxicities) At each treatment visit (weekly for first 4 weeks and then at least every 4 weeks through end of treatment) Evaluation of vital signs, clinical lab testing and adverse event monitoring (every other week), physical exam (every 4 weeks) and ECG (periodic)
- Secondary Outcome Measures
Name Time Method QT assessment Week 1, 7, 13, and 30 day follow-up visit Triplicate ECGs
Pharmacokinetic profile (assay for Anti-drug Antibody) Dose Escalation Cohort Week 1, 3, 7, 11, 15, 19, 23 and Final Visit Assay for Anti-drug antibody against ABT-806
Infusion rate evaluation (Expanded Safety Cohort) Every other week Two infusion times explored
Pharmacokinetic profile (assay for Anti-drug Antibody) Expanded Safety Cohort Week 1, 3, 7, 11, 15, 19, 23 and 30 Day Follow-up Assay for Anti-drug antibody against ABT-806
Trial Locations
- Locations (3)
Site Reference ID/Investigator# 43422
🇺🇸Tacoma, Washington, United States
Site Reference ID/Investigator# 54056
🇺🇸Baltimore, Maryland, United States
Site Reference ID/Investigator# 41931
🇺🇸Boston, Massachusetts, United States