The Phase I/II clinical trial of CSPC PHARMA (01093) investigating SYS6043 (B7-H3-ADC) as a monotherapy or in combination with bevacizumab and/or chemotherapy in participants with advanced solid tumors has officially commenced at the first site in China.
The open-label, multicenter Phase I/II clinical trial is designed to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of the company's developed SYS6043 (B7-H3-ADC) as a monotherapy or in combination with bevacizumab and/or chemotherapy in participants with advanced solid tumors.
The product is an antibody-drug conjugate (ADC) targeting B7-H3 developed by the company. Its antibody component can specifically bind to the surface of cells expressing B7-H3 and internalize into the cells. Its linker-drug consists of a tetrapeptide linker conjugated to a topoisomerase I inhibitor, which can release small molecule toxins after specific cleavage by proteases to kill tumor cells and exert a bystander effect to non-specifically kill surrounding tumor tissue cells.
Unlike antibodies using traditional wild-type Fc fragments, this product can reduce lymphocyte uptake and lower the risk of off-target toxicity, thereby improving treatment safety.
Previously, the company received the Drug Clinical Trial Approval Notice issued by the National Medical Products Administration in September 2026 for this product, and initiated the clinical trial after approval.
The clinical trial launched this time is an open-label, multicenter Phase I/II clinical trial aimed at evaluating the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of the product as a monotherapy or in combination with bevacizumab and/or chemotherapy in participants with advanced solid tumors.
Currently, participant recruitment and screening for this clinical trial are actively being advanced.
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