Spago Nanomedical AB has received approval to proceed with dose escalation in its ongoing Phase I/IIa Tumorad-01 trial evaluating the novel radiopharmaceutical 177Lu-SN201 in cancer patients. The recommendation comes from the independent Data Monitoring Committee (DMC) following analysis of safety data from six patients treated across five different cancer types.
The trial has successfully completed treatment of two patient cohorts, with the second group including two women diagnosed with lung and throat cancer respectively, and one man with rectal cancer. All patients received at least one dose cycle of 177Lu-SN201, with both cohorts demonstrating similar acceptable safety profiles.
"The DMC's decision allows us to advance to the next dose level, while our accelerating patient recruitment across multiple tumor types enhances our understanding of 177Lu-SN201's therapeutic potential," stated Mats Hansen, CEO of Spago Nanomedical. "This knowledge will be crucial for future development, and we remain on track to complete the Phase I portion of the study in 2025."
Trial Design and Progress
The Tumorad-01 first-in-human study aims to evaluate safety, tolerability, dosimetry, and preliminary efficacy of 177Lu-SN201 in cancer patients. The Phase I component focuses on identifying an optimal therapeutic dose for subsequent testing in selected patient populations during Phase IIa.
Preliminary imaging analysis indicates that 177Lu-SN201's biodistribution aligns with preclinical findings, while researchers continue to refine imaging and dosimetric calculation methods specifically tailored for the compound. The study currently operates across three dose levels, with active recruitment ongoing at both Cancer Research SA in Adelaide and St Vincent's Hospital in Melbourne.
Expanding Trial Framework
Following the successful treatment of the first patient cohort in August 2024, the company secured ethics approval to include a parallel lower-dose patient group. This strategic expansion allows for comprehensive dose-finding while maintaining the study's safety profile.
The trial's progress marks a significant step forward in developing novel radiopharmaceutical approaches for cancer treatment, with the potential to address multiple tumor types through targeted radiation delivery.
