A Study of ABT-806 in Subjects With Advanced Solid Tumor Types

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1 Study of ABT-806 in Subjects With Advanced Solid Tumor Types Likely to Either Overexpress Wild-Type Epidermal Growth Factor Receptor (EGFR) or to Express Variant III Mutant EGFR

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Drug: ABT-806


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABT-806 Arm<br> | Drug: ABT-806<br>* ABT-806 will be administered by intravenous infusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (Number of subjects with adverse events and/or dose-limiting toxicities) | Evaluation of vital signs, clinical lab testing and adverse event monitoring (every other week), physical exam (every 4 weeks) and ECG (periodic) | At each treatment visit (weekly for first 4 weeks and then at least every 4 weeks through end of treatment) | 
| Pharmacokinetic profile (assay for ABT-806) Dose Escalation Cohort | Assay for ABT-806 | Week 1, 2, 3, 5, 7, 8, 9, 11, 13, 15, 19, 23 and Final Visit | 
| Pharmacokinetic profile (assay for ABT-806) Expanded Safety Cohort | Assay for ABT-806 | Week 1, 3, 5, 7, 11, 13, 15, 19, 23 and 30 Day Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profile (assay for Anti-drug Antibody) Dose Escalation Cohort | Assay for Anti-drug antibody against ABT-806 | Week 1, 3, 7, 11, 15, 19, 23 and Final Visit | 
| QT assessment | Triplicate ECGs | Week 1, 7, 13, and 30 day follow-up visit | 
| Infusion rate evaluation (Expanded Safety Cohort) | Two infusion times explored | Every other week | 
| Pharmacokinetic profile (assay for Anti-drug Antibody) Expanded Safety Cohort | Assay for Anti-drug antibody against ABT-806 | Week 1, 3, 7, 11, 15, 19, 23 and 30 Day Follow-up |