Advanced Solid Tumors
Conditions
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.
Interventions
DRUGABT-806
ABT-806 will be administered by intravenous infusion.
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| QT assessment | Week 1, 7, 13, and 30 day follow-up visit | Triplicate ECGs |
| Infusion rate evaluation (Expanded Safety Cohort) | Every other week | Two infusion times explored |
Countries
United States
Outcome results
None listed