Spago takes Tumorad-01 study to the next level
Spago Nanomedical has increased the dose of its cancer drug candidate 177Lu-SN201 in its phase I/IIa Tumorad-01 study, following a recommendation from the independent Data Monitoring Committee. The decision stems from data on six patients across two cohorts with five different cancer types, all showing a satisfactory safety profile. This step keeps Spago on course to complete the phase I part in 2025.
Spago Nanomedical’s Tumorad-01 study, a first-in-human trial, assesses the safety, tolerability, dosimetry, and initial efficacy of 177Lu-SN201 in cancer patients. The ongoing phase I part aims to identify a potential therapeutic dose, which will later be assessed in selected patient groups in the phase IIa part of the trial.
The most recent patient group in the phase I study, consisting of three individuals, included two women with lung and throat cancer, respectively, and one man with rectal cancer. Each received at least one treatment cycle of 177Lu-SN201.
An analysis by the independent Data Monitoring Committee (DMC) has been conducted on all available patient data for the two first patient groups. The evaluation confirms a satisfactory safety profile, allowing the study to proceed with a higher dose level while continuing patient recruitment.
The first cohort, dosed by August 2024, prompted study continuation, while the second’s recent treatment led to the dose escalation.
Progress in imaging and dosimetry development
Beyond its primary goal of assessing safety, Tumorad-01 also focuses on refining imaging and dosimetry calculations to optimise the therapeutic application of 177Lu-SN201 and enable precise treatment planning. Early findings indicate that biodistribution patterns align with preclinical results, reinforcing confidence in the drug’s behavior within the body.
Expanding patient recruitment
Since August 2024, the company has been progressively advancing the study, following the successful treatment of the first patient group. At that time, the DMC also endorsed the continuation of the study, paving the way for dose adjustments and patient recruitment expansions. Spago has received ethics approval to simultaneously enroll patients at a lower dose level, further broadening the study’s scope. Currently, the study is actively recruiting patients at both the higher and lower dose levels at Cancer Research SA in Adelaide and St Vincent’s Hospital in Melbourne.
Advancing toward completion of phase I this year
With the DMC’s recommendation to increase the dose, patient enrollment progressing, and imaging techniques continuously refined, Spago Nanomedical remains on track to complete the study this year:
– The recruitment of patients with multiple tumor types is accelerating while we continuously strengthen the understanding of how 177Lu-SN201 works in different cancer types. This knowledge will be of great importance for the next step. Our goal to complete the phase I part of the study in 2025 remains unchanged, says CEO Mats Hansen.
The study’s advancements will not only help establish an optimal therapeutic dose but also provide critical data for the future development of 177Lu-SN201 as a potential new treatment for multiple cancer types.
– We are very pleased with the DMC’s decision, and the study is now proceeding to the next dose level, Mats Hansen concludes.
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