Kelun-Biotech, a subsidiary of Kelun Pharmaceutical, revealed promising findings from its first-in-human study of SKB500, a novel B7-H3-targeted antibody-drug conjugate (ADC), at the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting in Chicago. This innovative treatment is aimed at patients with advanced solid tumors.
Study Details and Results
The study, led by Professor Liu Haifeng from Jilin Provincial Cancer Hospital, involved 192 patients with various types of advanced solid tumors, including small cell lung cancer (SCLC), esophageal squamous cell carcinoma (ESCC), and others. Patients received SKB500 at doses ranging from 2 to 18 mg/kg every three weeks. The study was conducted in three stages: dose escalation, dose expansion, and indication expansion.
Results showed significant antitumor activity across multiple tumor types. For patients treated at 12 mg/kg, the objective response rate (ORR) was 42.7%, and the disease control rate (DCR) was 83.9%. Notably, among SCLC patients, the ORR was 65.0%, with a median progression-free survival of 7.2 months.
Safety and Future Prospects
SKB500 demonstrated a favorable safety profile, particularly at the 12 mg/kg dose, with a lower incidence of severe treatment-related adverse events compared to the 16 mg/kg group. The study reported no treatment-related deaths, and the rate of permanent discontinuation was low.
Professor Liu emphasized the potential of SKB500 as a therapeutic option for aggressive cancers like SCLC, which have limited treatment options. The findings lay the groundwork for further clinical trials to validate SKB500’s efficacy and safety.
About Kelun-Biotech
Kelun-Biotech focuses on developing innovative biological and small molecule drugs, addressing unmet medical needs globally. The company is advancing multiple projects, with several already approved for marketing. SKB500 is part of their proprietary OptiDC™ platform, which has shown promise in treating various cancers.
Original reporting: KTBS 3 (Shreveport) — read the source article.
