HENLIUS (02696): The phase 1b/2 clinical study of HLX701 in combination with cetuximab and chemotherapy for the treatment of advanced colorectal cancer has completed its first patient dosing in China.

HENLIUS (02696) announced that recently, the phase 1b/2 clinical study of HLX701 (recombinant human SIRP-IgG4 Fc fusion protein injection) in combination with cetuximab and chemotherapy for advanced colorectal cancer has completed the first patient dosing in China (excluding China Hong Kong, Macau, and Taiwan regions). This study is a phase 1b/2 clinical study comparing HLX701 in combination with cetuximab and chemotherapy (FOLFOX/FOLFIRI) vs. placebo in combination with cetuximab and chemotherapy (FOLFOX/FOLFIRI) in patients with recurrent, unresectable, or metastatic RAS/BRAF wild-type colorectal cancer who have previously received chemotherapy. The study includes three stages: the first stage is a safety lead-in period with a 3+3 dose escalation design, with 4 dose groups ranging from 5 mg/kg to 18 mg/kg, where subjects will receive different doses of HLX701 in combination with cetuximab and chemotherapy (FOLFOX/FOLFIRI) once a week via intravenous administration; the second stage includes 3 dose groups ranging from 8 mg/kg to 18 mg/kg, administered once a week via intravenous administration to evaluate the clinical efficacy and safety of different dose levels of HLX701 in combination with cetuximab and chemotherapy (FOLFOX/FOLFIRI); the third stage is a randomized, double-blind, multicenter study comparing the efficacy and safety of HLX701 or placebo in combination with cetuximab and chemotherapy. The primary endpoint of the first stage of the study is to assess the incidence of dose-limiting toxicity (DLT), with secondary endpoints including safety measures, objective response rate (ORR), disease control rate (DCR), PK parameters, immunogenicity, etc.; the primary endpoint of the second stage is to explore the recommended phase 2 dose (RP2D), ORR evaluated by an Independent Imaging Review Committee (BICR), and progression-free survival (PFS); the primary endpoint of the third stage is ORR and PFS evaluated by BICR, with secondary endpoints in the second and third stages including safety measures, overall survival (OS), ORR and PFS evaluated by the investigator, PK parameters, immunogenicity, and exploration of the correlation between biomarkers and efficacy. HLX701 is a SIRP-Fc fusion protein introduced under license by the company from FBD Biologics Limited, intended for the treatment of various late-stage solid tumors. Multiple phase 1/2 clinical trials of this product are currently underway globally. Under the licensing arrangement, the company has exclusive rights to develop, manufacture, and commercialize HLX701 in China (excluding Taiwan) as well as specific countries in Southeast Asia, the Middle East, and North Africa. HLX701 is an engineered recombinant human SIRP immunoglobulin (IgV) domain fused with the crystallizable (Fc) region of human immunoglobulin G4 (IgG4). By binding to CD47 on tumor cells, HLX701 effectively blocks inhibitory CD47 "don't eat me" signals, promoting macrophage phagocytosis of tumor cells and enhancing anti-tumor activity. Preclinical studies have shown that HLX701 can have a synergistic effect with chemotherapy, immune checkpoint inhibitors, epidermal growth factor receptor inhibitors, and anti-angiogenic agents, suggesting that combining HLX701 with standard treatment regimens may enhance innate and adaptive immune responses. In January 2026, the application for the phase 1b/2 clinical trial of HLX701 in combination with cetuximab and chemotherapy for the treatment of advanced colorectal cancer received approval from the National Medical Products Administration (NMPA). As of the date of this announcement, there are no SIRP-Fc fusion proteins targeting CD47 approved for marketing globally.