Safety of the Herbal Medicine SH003 in Patients With Solid Cancer: A Multi-Center, Single-Arm, Open-Label, Dose-Escalation Phase I Study

Background: SH003, a novel herbal medicine comprising Huang-Qi, Dang-Gui, and Gua-Lou-Gen, has historical roots in traditional medicine with reported anticancer properties. The need to explore safe and effective treatments in oncology underlines the importance of this study. Methods: This phase I trial, conducted at Ajou University Hospital and Gachon University Gil Medical Center in Korea, adopted a single-arm, open-label, dose-escalation design. It aimed to evaluate the safety of escalated doses of SH003 in patients with various solid cancers, focusing on determining its maximum tolerated dose. Participants with confirmed solid cancers, unresponsive to standard treatments, were enrolled. The dosage of SH003 was escalated from 4800 to 9600 mg per day, using a 3 + 3 design. Safety was assessed based on the Common Terminology Criteria for Adverse Events ver. 5.0. Results: The study established that the maximum tolerated dose of SH003 is 9600 mg/day. Most adverse events were mild, primarily including dizziness and nausea, indicating the tolerability of SH003 at this dosage. Conclusions: SH003 demonstrates safety and promises as an anticancer treatment at doses up to 9600 mg/day. This research supports further investigation into its efficacy for cancer therapy, emphasizing the significance of natural products in oncology, particularly concerning patient safety and tolerance.