A Phase I, Open-Label, Multi-center, Competitive Enrollment and Dose-escalation Study of ALT-836 in Combination With Gemcitabine for Locally Advanced or Metastatic Solid Tumors
Tissue Factor (TF) is over-expressed in most cancer types. Results from many recent studies
have suggested a key role for TF in the development of cancer-associated thrombosis, tumor
growth, tumor angiogenesis, and tumor metastasis. ALT-836, a recombinant human-chimeric
monoclonal antibody, is designed as a direct TF antagonist to block TF displayed by cancers
and to inhibit cancer-associated venous thromboembolism, tumor growth, tumor angiogenesis
and tumor metastasis. In numerous pre-clinical studies in laboratory animals, including
non-human primates, ALT-836 exhibits potent anti-tumor, anti-thrombotic and
anti-inflammatory activities with a remarkable safety profile. In humans, ALT-836,
administered as a single bolus and monotherapy in patients with coronary artery disease
(CAD) and acute lung injury/acute respiratory distress syndrome (ALI/ARDS), is safe and
exhibits anti-coagulant and anti-inflammatory effects. A Phase II study using a multi-dose
regimen of ALT-836 is being conducted in patients with ALI/ARDS. In the dose-escalation
study described in this protocol, the investigators will assess the safety and determine the
maximum tolerated dose (MTD) of ALT-836 in combination with gemcitabine in patients with
advanced malignancies known to overexpress TF and in which venous thromboembolism is a major
complication.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD) of ALT-836 in combination with gemcitabine
18 months
Yes
United States: Food and Drug Administration
CA-ALT-836-02-10
NCT01325558
May 2011
October 2013
Name | Location |
---|---|
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
Carolinas Hematology-Oncology Associates | Charlotte, North Carolina 28203 |
University of Rochester Medical Center, James P. Wilmot Cancer Center | Rochester, New York 14642 |
Emory University, Winship Cancer Institute | Atlanta, Georgia 30322 |