Spago Nanomedical AB received a positive recommendation from its Data Monitoring Committee (DMC) to continue patient recruitment in the ongoing phase I/IIa study Tumorad-01, evaluating the radioligand therapy candidate 177Lu-SN201 in cancer patients. The recommendation follows analysis of safety data from 10 patients across three dose cohorts, demonstrating an acceptable safety profile that supports advancement to higher dose levels.
Safety Profile Supports Dose Escalation
The DMC's analysis encompassed data from all three patient cohorts, totaling 10 dosed patients with eight different tumor types. One patient has received treatment at the current highest dose of 15 MBq/kg, with safety remaining acceptable and consistent across all patients. The observed side effects are primarily related to transient platelet impacts, which are expected with radioactive treatments.
"The recommendation to continue the study according to the current protocol is of great importance as it confirms that the safety profile of our candidate drug 177Lu-SN201 remain acceptable even at the highest dose level tested to date," said CEO Mats Hansen. "With three different dose levels evaluated in a larger number of patients with various tumor types, we will have a strong basis and good opportunities to develop the robust documentation needed for upcoming phases with a main focus on efficacy."
Study Design and Progression
The Tumorad-01 study represents a first-in-human evaluation of 177Lu-SN201, designed to assess safety, tolerability, dosimetry, and initial efficacy in cancer patients. The phase I portion focuses on safety assessment and identification of therapeutic dosing for subsequent testing in selected patient groups during the phase IIa segment.
The study currently evaluates three dose levels: 5, 10, and 15 MBq/kg. Following the DMC recommendation, recruitment will continue with two additional patients at the 15 MBq/kg dose level, while treatment at the lower 5 MBq/kg dose continues in parallel. No dose-limiting toxicity has been reported across any cohort.
Clinical Operations and Timeline
Patient recruitment continues at two Australian hospitals: Cancer Research SA in Adelaide and St Vincent's Hospital in Melbourne. The study plans to enroll approximately 12 patients total, with Spago Nanomedical targeting completion of the phase I portion within 2025.
The third patient cohort, consisting of one individual with liver cancer, has completed treatment with one dose cycle of 177Lu-SN201. This follows the DMC's earlier recommendation in March 2025 to proceed to higher dosing levels, demonstrating consistent progress in the dose-escalation strategy.
Therapeutic Development Platform
177Lu-SN201 is built on Spago Nanomedical's platform of polymeric materials designed for precise cancer treatment and diagnosis. The Swedish company focuses on developing therapies that leverage unique material properties to improve targeting and reduce systemic toxicity in cancer treatment applications.
The positive safety data across multiple tumor types positions 177Lu-SN201 for potential broad applicability in oncology, though efficacy evaluation will be the primary focus of subsequent study phases. The company's systematic approach to dose escalation and safety monitoring provides a foundation for advancing the candidate through clinical development.
