Spago Nanomedical proceeds to the next dose level in the phase I/IIa study Tumorad-01

Spago Nanomedical AB (publ) announced today that the independent data monitoring committee has recommended a dose escalation in the company's clinical phase I/IIa study Tumorad-01 with the candidate drug 177Lu-SN201. The recommendation is based on an analysis of data from the first dosed patient in the study showing that the safety profile of their first treatment cycle held no concerns. The study continues according to plan.

Tumorad-01 is a phase I/IIa first-in-human study in patients with advanced cancer with the primary objective of evaluating safety, tolerability, dosimetry and initial efficacy of 177Lu-SN201. The first patient was successfully treated with the initial dose of 10 MBq/kg. Following a recommendation from the data monitoring committee, the company has decided to proceed to the next planned dose level of 25 MBq/kg.

The phase I part of the study aims to identify, based on safety and biodistribution, a possible therapeutic dose for further testing in selected patient groups in the phase IIa part of the study. Patient recruitment is proceeding according to plan and initial data from the phase I part of the study is expected to be reported later in the first half of 2024.

More information about the study is available at https://clinicaltrials.gov/study/NCT06184035