SN BioScience Inc, a clinical-stage biotechnology company based in South Korea, announced on Thursday that it has started the first patient dosing in its global Phase 1b/2 clinical trial evaluating SNB-101 (API: SN-38), a nanoparticle anticancer agent, in patients with Extensive-Stage Small Cell Lung Cancer (ES-SCLC).

Taking place in across sites globally including the United States and Europe, the trial will enrol up to 135 patients.

The study is designed in three sequential stages: a Phase 1b dose-escalation phase using a 3+3 design to determine the Maximum Tolerated Dose (MTD) at dose levels of 50-70 mg/m-2, followed by a two-part Phase 2. Phase 2a will conduct dose optimisation to identify the optimal therapeutic dose, after which Phase 2b will proceed with dose expansion at the optimised dose to further evaluate clinical activity across a broader patient population. Key efficacy endpoints in Phase 2 including objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) will be assessed to generate the clinical evidence necessary to support regulatory review process.

SN BioScience is also pursuing the expansion of SNB-101 into additional solid tumour indications, including gastric and pancreatic cancers, through ongoing collaborations and strategic discussions with global pharmaceutical companies.