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



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:11/23/2017
Start Date:November 2010
End Date:November 2012

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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

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.


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.
We found this trial at
3
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Tacoma, WA
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