CSPC Pharmaceutical Group has initiated phase 1/2 clinical trial of SYS6043 for the Solid tumor in China

CAR-T Digest - August 2020

30 October 2026: CSPC Pharmaceutical Group has initiated Phase 1/2 clinical trial of SYS6043 for the Solid tumor in China

CSPC Pharmaceutical Group has initiated the first-site Phase 1/2 clinical trial of SYS6043, an investigational B7-H3-targeted ADC, in China, evaluating the candidate as monotherapy and in combination with bevacizumab and/or chemotherapy in patients with advanced solid tumor
The open-label, multicenter Phase 1/2 study will assess safety, tolerability, pharmacokinetics and preliminary antitumor activity. The trial follows NMPA clinical trial approval in September 2026, with patient recruitment and screening now underway
The program targets B7-H3, an antigen expressed across multiple solid tumors, offering a potential targeted treatment approach for patients with advanced disease and limited therapeutic options. The combination arms will also explore whether B7-H3-directed cytotoxic delivery can be enhanced alongside anti-angiogenic therapy or chemotherapy
SYS6043 uses a B7-H3-targeting antibody linked through a cleavable tetrapeptide linker to a topoisomerase I inhibitor payload. Protease-mediated linker cleavage releases the cytotoxic payload inside tumor cells, with a bystander effect intended to extend activity to neighboring tumor cells. CSPC also highlights an engineered Fc region designed to reduce lymphocyte uptake and potentially lower off-target toxicity