First patient dosed for a Phase 1b/2 clinical trial of PD-L1 ADC HLX43 combination therapy in advanced colorectal cancer

CAR-T Digest - August 2020

Weekly Digest - February 2026

11 February 2026: First patient dosed for a Phase 1b/2 clinical trial of PD-L1 ADC HLX43 combination therapy in advanced colorectal cancer

Shanghai Henlius Biotech announced that the first patient has been dosed in China in a Phase 1b/2 clinical trial evaluating its PD-L1 antibody–drug conjugate HLX43 in combination with the anti-PD-1 antibody serplulimab or the company’s anti-EGFR monoclonal antibody HLX07 in patients with advanced or metastatic colorectal cancer
The study marks a further expansion of HLX43’s global development program, which is currently being explored across 10 clinical trials in multiple solid tumors, including non-small cell lung cancer, cervical cancer, esophageal squamous cell carcinoma, head and neck cancer, nasopharyngeal carcinoma, gastric cancer, pancreatic cancer, and colorectal cancer
Advanced colorectal cancer remains an area of high unmet need, particularly in later-line settings where treatment options are limited and outcomes remain poor despite prior chemotherapy, anti-VEGF, anti-EGFR, or immunotherapy approaches depending on molecular subtype
HLX43 is designed as a dual-mechanism PD-L1–targeted ADC that combines immune checkpoint blockade with payload-mediated cytotoxicity, aiming to provide biomarker-independent, broad-spectrum anti-tumor activity, and has already demonstrated encouraging efficacy and manageable safety across multiple solid tumor studies
With combination strategies now advancing in colorectal cancer and other tumor types, Henlius continues to position HLX43 as a core pipeline asset, seeking to expand its pan-tumor potential and deliver differentiated therapeutic options for patients with advanced malignancies