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

NCT ID: NCT01255657

Last Updated: 2017-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2012-11-30

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.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ABT-806 Arm

Group Type: EXPERIMENTAL

ABT-806

Intervention Type: DRUG

ABT-806 will be administered by intravenous infusion.

Interventions

ABT-806

ABT-806 will be administered by intravenous infusion.

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyle D. Holen, MD

Role: STUDY_DIRECTOR

AbbVie

Locations

Site Reference ID/Investigator# 54056

Baltimore, Maryland, United States

Site Reference ID/Investigator# 41931

Boston, Massachusetts, United States

Site Reference ID/Investigator# 43422

Tacoma, Washington, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 25761639 (View on PubMed)

Other Identifiers

M11-847

Identifier Type: -

Identifier Source: org_study_id