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

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

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.

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: ABT-806

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • Site Reference ID/Investigator# 54056
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Site Reference ID/Investigator# 41931
  • Washington
    • Tacoma, Washington, United States, 98405
      • Site Reference ID/Investigator# 43422

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABT-806 Arm	Drug: ABT-806; ABT-806 will be administered by intravenous infusion.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AbbVie (prior sponsor, Abbott)
• Investigators: Study Director: Kyle D. Holen, MD, AbbVie

Publications and helpful links

General Publications

• Sharma S, Mittapalli RK, Holen KD, Xiong H. Population Pharmacokinetics of ABT-806, an Investigational Anti-Epidermal Growth Factor Receptor (EGFR) Monoclonal Antibody, in Advanced Solid Tumor Types Likely to Either Over-Express Wild-Type EGFR or Express Variant III Mutant EGFR. Clin Pharmacokinet. 2015 Oct;54(10):1071-81. doi: 10.1007/s40262-015-0258-2.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: November 22, 2010
• First Submitted That Met QC Criteria: December 6, 2010
• First Posted (Estimate): December 7, 2010

Study Record Updates

• Last Update Posted (Actual): November 21, 2017
• Last Update Submitted That Met QC Criteria: November 17, 2017
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: M11-847