The Phase I study is an open-label, dose-escalation clinical trial in patients with non-resectable or metastatic solid tumors. The primary objectives of the clinical protocol submitted with the investigational new drug application (IND) are to evaluate the safety and tolerability of CALAA-01 in humans. Additional objectives include characterization of pharmacokinetics, evaluation of tumor response, and recommendation of a CALAA-01 dose for future clinical studies.
The trial will be conducted at the UCLA Jonsson Cancer Center in Los Angeles, California, and the South Texas Accelerated Research Therapeutics clinic in San Antonio, Texas.
Jeremy Heidel, chief scientific officer of Calando, said: “We believe this trial will be the first clinical study using targeted, systemic delivery of siRNA in an oncology setting.”