Research and Clinical Trials

Brief Description  
This is a Phase I, open label, multi-center, competitive enrollment and dose-escalation study of ALT-836 in combination with standard of care gemcitabine in patients who have locally advanced or metastatic solid tumors.
Who may be Eligible  

Inclusion Criteria

Eligible subjects must meet the following criteria to be enrolled in the study:

  • Histologically or cytologically confirmed, measurable, locally advanced or metastatic non-hematologic malignancy
  • Age > 18 years
  • No concurrent radiotherapy, chemotherapy or other immunotherapy

Exclusion Criteria:

You may not be eligible to participate in this study if any of the following apply:

  • You are currently receiving other investigational medications
  • History of an allergic reaction to Gemcitabine or a type of drug called a monoclonal antibody (ALT-836 is an example of a monoclonal antibody)
  • History of any of the following within the past 6 months: heart attack, unstable angina, heart rhythm abnormalities requiring medications, a type of heart surgery called bypass grafting, stroke or TIA (Transient ischemic attack [mini stroke]), symptomatic peripheral arterial disease
  • History of clinically significant renal, endocrinologic, metabolic, immunologic, or hepatic disease
  • History of or presence of CNS disease (e.g., brain metastases, primary brain tumor, seizures not controlled with standard medical therapy)
  • History of bleeding disorders unless corrective surgery has been performed; presence of serious non healing wound or ulceration, or signs of other bleeding
  • Major surgery or open biopsy within 28 days before study drug infusion, or plan for any major surgery during study treatment period
  • Known HIV-positive
  • Women who are pregnant or nursing
Speciality/Disorder  
Cancer (other)
IRB Number  
05-11-03A
Principal Investigator  
Limentani, Steven

For More Information, Contact  Angela  P, Anderson
Phone:  (704) 355-8246  Fax:  (704) 355-1353  
Email:  angela.p.anderson@carolinashealthcare.org
Address:1100 South Tryon Street Suite 220 Charlotte, NC 28203
Close