The abstract, accepted in the “Clinical Trials in Theranostics” category at the conference themed “From Concept to Cure: Transforming Healthcare with Nuclear Medicine”, was selected for an oral presentation and delivered by Associate Professor Kim Taubman, principal investigator of the Tumorad-01 study at St. Vincent’s Hospital in Melbourne. The presentation described the Tumorad-01 study, including imaging data from exploratory SPECT/CT by the site, demonstrating visible tumor uptake of ¹⁷⁷Lu-SN201 in two patients, one with adenoid cystic carcinoma and the other with squamous cell carcinoma of the tongue (SCC).

“We view the clearly visible tumor uptake observed in various involved tissues including lymph nodes, in patients with severe forms of head and neck cancer very positively. These findings are consistent with earlier observations and support the proposed mechanism of action, strengthening our confidence in the program as the study progresses to the next phase,” says Associate Professor Kim Taubman.

The tumor uptake observed across patients supports the mechanism of action of Tumorad in humans and forms the basis for the independent Data Monitoring Committee’s (DMC) assessment that the findings can be considered proof-of-concept for Tumorad as a potential new treatment approach for advanced cancer. The study is now progressing towards definition of the recommended phase II dose (RP2D), another primary objective of the Phase I part of the study, which will form the foundation for continued clinical development in Phase II, where the focus will shift to generating efficacy data in selected tumor indications.

The phase I/IIa Tumorad-01 study is a first-in-human study designed to evaluate the safety, tolerability, dosimetry, and initial efficacy of ¹⁷⁷Lu-SN201 in adult patients with progressive or treatment-resistant advanced, unresectable, or metastatic solid tumors. The study is conducted with predefined evaluations performed by DMC. Additional patients are to be enrolled in the patient cohort.

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