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A phase I study of AGRO100 in advanced cancer.

3112 Background: AGRO100 is an oligonucleotide that functions as an aptamer and binds to nucleolin, a protein found intranuclear in all cells, but uniquely expressed on the surface of tumor cells. Such binding leads to internalization of the complex, and a strong anti-proliferative response in the tumor cell.


METHODS
Objectives are toxicity, pharmacokinetics and preliminary responses. AGRO100 was administered as continuous intravenous infusion over 96 hours in the hospital. Dose level 1 was 1 mg/kg/day. Patients were enrolled in cohorts of 3. If no toxicity was observed 28 days after therapy, the dose of AGRO100 was doubled. Toxicity was graded by the NCI CTCAE v3.0. Responses were assessed every 28 days by using the RECIST guidelines.


RESULTS
From September 2003 through December 2003, 9 patients with advanced cancer were enrolled. Prior to AGRO100 treatment, all patients had objective documentation of progressive metastatic disease after multiple therapies. Patient characteristics: [Figure: see text] 9 patients are evaluable for toxicity and 6 for response. 13 cycles of AGRO100 have been administered (1-2 cycles/patient). 4/6 patients had stable disease after 1 treatment and received a second course. 2/6 patients progressed after 1 cycle. No toxicity of any type has been observed. AGRO100 was present in the serum during the entire infusion and the concentration was related to the dose. Further dose escalation is ongoing.


CONCLUSIONS
AGRO100 is the first nucleic acid aptamer ever tested for the treatment of cancer in humans. This non-toxic targeted cancer therapy achieved stable disease in 67% of the patients. [Table: see text].