Advancing to Higher Dose in Tumorad-01 Phase I/IIa Trial

Participants in a clinical trial for advanced cancer treatment will receive [177Lu]Lu-SN201 through a slow IV infusion during the first cycle. The treatment may continue for up to three cycles, with each cycle spaced six weeks apart, and the entire treatment period not exceeding 22 weeks. A mandatory overnight hospital stay is required after the initial infusion for observation.

Following the administration of [177Lu]Lu-SN201, whole-body imaging and SPECT/CT scans will be conducted to evaluate the distribution of the drug within the body and to calculate the radiation dose received by the patient. Additionally, CT or MRI will be used to assess the treatment's effectiveness based on the Response Evaluation Criteria (RECIST v1.1).

The trial's phases involve baseline measurements taken before the infusion begins, ongoing monitoring of adverse events and medications, and imaging procedures on specific days post-infusion. If previous participants have met dosimetry requirements at a certain dose level, the Data Monitoring Committee may reduce or waive the need for further dosimetry evaluations at that level.

For those who are eligible to proceed to the second or third cycle, an assessment of eligibility and procurement of the investigational medicinal product will take place within a specified timeframe. The study aims to determine the safety, tolerability, dosimetry, and preliminary efficacy of [177Lu]Lu-SN201 in treating patients with advanced cancer.