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

AbbVie

Status and phase

Completed

Phase 1

Conditions

Advanced Solid Tumors

Treatments

Drug: ABT-806

Study type

Interventional

Funder types

Industry

Identifiers

NCT01255657

M11-847

Details and patient eligibility

About

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.

Enrollment

49 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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.