The open-label dose escalation trial in patients with progressive metastatic malignancies is currently ongoing at the H Lee Moffitt Cancer Center, Tampa, Florida, and at the M D Anderson Cancer Center, Orlando, Florida. The primary objectives of the study are to evaluate the safety, determine the maximum-tolerated dose (MTD) and characterize the pharmacokinetic profile of ALT-801.
The secondary objectives are to evaluate the immunogenicity and assess the antitumor response. Following MTD determination, the trial will be expanded to treat additional patients for further assessment of ALT-801’s safety and antitumor activity. To date, no dose-limiting toxicities have been observed in patients who have completed the multidose treatment course at the first dose level. Preliminary results also indicate that ALT-801 is biologically active at this dose level in patients.
Altor also reported that the expansion phase of this clinical trial will be supported in part through funding awarded by the FDA Orphan Products Development grant program. ALT-801 is a novel tumor-targeted immunotherapeutic designed to improve on the efficacy and safety of the FDA-approved anticancer cytokine, interleukin-2 (IL-2).
Hing Wong, president and CEO of Altor, said: “Having renowned cancer research centers conducting this study combined with the FDA grant validates the strong interest in this product candidate and therapeutic approach.”