The independent Data Monitoring Committee (DMC) has approved the continuation of Spago Nanomedicals Phase I/IIa study Tumorad-01 at the highest current dose of 15 MBq/kg for the company's radiopharmaceutical candidate, 177Lu-SN201The decision follows a review of data from ten patients in three cohorts, representing eight different cancers, including lung, throat, rectal and liver cancer. The approval builds on previous reviews, including a decision in March 2025 to increase the dose, confirming the study's steady progress. See Paul Hargreaves, CDO at Spago Nanomedical, explaining the meaning here.
The study, which is being conducted at Cancer Research SA in Adelaide and St Vincent's Hospital in Melbourne, shows a manageable safety profile, with side effects mainly including temporary decreases in platelets, which is common with radiopharmaceutical treatments. The fact that the study covers multiple cancer types means that its results can provide guidance on appropriate therapeutic applications going forward.
Raking the arena for phase IIa
The Tumorad-01 study is a First-in-Humanstudy evaluating the safety, tolerability, dosimetry and initial efficacy of 177Lu-SN201 in patients with advanced cancers. The Phase I part will identify an appropriate therapeutic dose for further evaluation in Phase IIa, where specific patient populations will be targeted. The study is currently testing three dose levels – 5, 10 and 15 MBq/kg – with the latest cohort involving a single patient with liver cancer treated with the highest dose. No dose-limiting toxicities have been observed, supporting continued dose exploration and enabling the recruitment of two additional patients to the 15 MBq/kg dose, in parallel with ongoing enrollment to the lower dose of 5 MBq/kg.
Expanded patient recruitment in Australia
Since August 2024, Spago has advanced the study based on previous guidance from DMC, including a recommendation in March 2025 to proceed with a higher dose. The company has received ethical approval to enroll patients at both higher and lower doses simultaneously, broadening the study’s data collection. A total of approximately 12 patients are expected to be enrolled, with active enrollment ongoing at specialist oncology units at two Australian study sites. This ensures robust data across cancer types, enhancing the study’s ability to guide future clinical steps and strengthening the foundation for future phases.
The treatment is fine-tuned
In addition to ensuring safety, the study results contribute to refining imaging and dosimetry techniques to optimize the therapeutic potential of 177Lu-SN201. Preliminary dosimetry results are well in line with preclinical data and confirm consistent biodistribution patterns. These findings are crucial for high precision in treatment planning and enable tailored therapies – as personalized treatments gain widespread traction in the oncology field. Overall, the study results should contribute to an increased understanding of the candidate's behavior in the human body.
CEO comments
We talked to Matt Hansen, CEO of Spago Nanomedical, to discuss the next steps for 177Lu-SN201 after DMC approval.
How does the safety profile support 177Lu-SN201's path to future phases?
- DMC's recommendation to continue patient recruitment is an important confirmation of the safety for the program, especially as we now have started dosing on the higher dose 15 MBq/kg and we still only see mild side effects mainly related to a transient impact on the platelets. With several dose levels tested in various tumor types, we will have a strong basis and good opportunities to develop the robust documentation needed for upcoming clinical phases with a main focus on efficacy.
How will the DMC's recommendation impact the phase I completion timeline?
– We can now continue the Tumorad-01 trial according to the current study protocol, including recruiting two additional patients at the highest dose, with the aim to complete the phase I part of the study in 2025.
Are you engaging with additional potential partners for 177Lu-SN201's development?
- Yes, we are actively working to identify and engage potential partners who share our vision and who see the medical and commercial value in our programs, not only for Tumorad, but also for our SpagoPix program with product candidate pegfosimer manganese. In line with the continued strong interest in radionuclide therapies within the industry and several major global pharmaceutical companies making significant investments in the field, we also notice increasing interest in our programs.
What are the benefits of testing both high and low doses concurrently?
- We received ethics approval to include patients in parallel on a lower dose at the beginning of this year. The objective of this approach is to gain additional knowledge and basis for various dosing regimes in the next steps.
What feedback has Australian clinicians shared about the study?
- All involved personnel at the two recruiting clinics are very supportive, and we have received positive feedback from participating clinicians as well as patients. Feedback on the study protocol has been favorable, especially regarding the patient-centric approach we have taken to ensure individuals can undertake all the necessary procedures a clinical trial like this requires. Patients' feedback is positive especially as they are not having any physically limiting side effects to treatment.
Finally – what is your vision for 177Lu-SN201's role in advancing cancer therapy?
- In Tumorad, nanoparticles for physiological accumulation in tumors are loaded with clinically effective radioactive isotopes, which can open for effective internal radiation therapy of aggressive and spread cancer. Tumorad can thus provide the opportunity to treat cancer diseases that cannot be treated with other types of radioactive drugs. With this unique approach and mode of action we are convinced that Tumorad has the potential to become an important part of future cancer treatment.
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