Recently, Shanghai Henlius Biotech, Inc. (2696.HK) successfully held an in-person investigator meeting in San Francisco for the HLX22-GC-301 trial. The meeting focused on the global, multicentre Phase 3 clinical trial evaluating the novel epitope anti-HER2 mAb HLX22 in combination with trastuzumab and chemotherapy as first-line treatment for HER2-positive advanced gastric cancer. Nearly 30 leading oncologists and clinical researchers from more than 20 clinical trial sites, including The University of Texas MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center, attended the meeting. Participants engaged in in-depth discussions on the current treatment landscape for HER2-positive metastatic gastric cancer, safety management of HER2-targeted therapies, and key aspects of the HLX22-GC-301 trial protocol. The HLX22-GC-301 trial is co-led globally by Dr. Lin Shen of Beijing Cancer Hospital and Dr. Jaffer A. Ajani, Professor of Medicine at University of Texas MD Anderson Cancer Center. The trial has completed the dosing of the first patient across multiple countries and regions, including China, the United States, Japan, Australia, and Argentina.
HLX22 is a novel monoclonal antibody targeting a unique epitope on HER2. It can bind to HER2 simultaneously with trastuzumab, significantly enhancing the internalization and degradation of HER2 homodimers and HER2/EGFR heterodimers, increasing HER2 internalization efficiency by 40%–80% and resulting in stronger HER2 receptor blockade. Updated results from the Phase 2 HLX22-GC-201 trial, evaluating HLX22 in combination with trastuzumab in HER2-positive gastric cancer, were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. With a median follow-up of over two years, the combination continued to demonstrate durable and clinically meaningful efficacy, exceeding historical benchmarks¹. HLX22-GC-301 is a randomized, head-to-head, international multicentre Phase 3 trial comparing HLX22 plus trastuzumab and chemotherapy with the current standard first-line regimen (trastuzumab plus chemotherapy ± pembrolizumab). The trial includes patients regardless of PD-L1 expression status and aims to address the limitations of current first-line treatment options for HER2-positive metastatic gastric and gastroesophageal junction cancer.
Dr. Jaffer A. Ajani, M.D., Global Principal Investigator of the HLX22-GC-301 trial, Chair of the NCCN Gastric and Esophageal Cancers Panel, Professor of Medicine at University of Texas MD Anderson Cancer Center, commented: “HLX22 is a unique monospecific antibody directed to the extracellular domain 4 of the HER2 receptor. Mature results of a randomized phase 2 data are very encouraging when HLX22 is combined with trastuzumab and chemotherapy, compared to the placebo with trastuzumab and chemotherapy. Based on these results, the pivotal HLX22 Gastric Cancer phase 3 study (HLX22-GC-301) is rapidly accruing patients globally and we look forward to changing the therapeutic landscape in this space.”
Dr. Yelena Janjigian, M.D., U.S. Principal Investigator of the HLX22-GC-301 trial and Petrie Chair and Chief of the Gastrointestinal Oncology Service at Memorial Sloan Kettering Cancer Center, stated: “First-line treatment is the most critical opportunity to impact long-term outcomes in HER2-positive gastric and gastroesophageal cancer. HLX22 is a unique and well-tolerated HER2-targeted antibody designed to deepen HER2 blockade beyond what is achievable with current approaches. The Phase 3 HLX22-GC-301 trial is an important step toward defining whether more complete HER2 inhibition can meaningfully improve outcomes for patients in the frontline setting.”
Jing Li, Vice President of Global Product Development at Henlius, said: “The U.S. investigator team plays a critical role in trial design interpretation, patient management, and execution quality for HLX22-GC-301. This investigator meeting provided an important platform for alignment and in-depth communication across sites, helping to further enhance consistency and standardization of trial implementation across regions. Henlius will continue to advance global clinical development to the highest standards, working closely with our international investigator partners to accelerate the global clinical validation and value realization of the differentiated innovative asset HLX22.”
Through this investigator meeting, Henlius and the U.S. investigator community further strengthened alignment on trial protocol understanding, patient management strategies, and trial execution standards, helping improve the consistency and standardization of the trial execution in different regions, which provides strong support for the high-quality advancement of the HLX22-GC-301 trial. Looking ahead, Henlius will continue to collaborate closely with its global clinical network to accelerate the international development of HLX22 and other innovative assets, and to explore more clinically meaningful treatment options for patients with HER2-positive gastric cancer worldwide.
Dr. Janjigian provides advisory services to Henlius.
Reference
1. Jin Li et al. HLX22 plus trastuzumab and XELOX for first-line treatment of HER2-positive locally advanced or metastatic gastric/gastroesophageal junction cancer (G/GEJC): Updated results with additional patients.. JCO 43, 440-440(2025). DOI:10.1200/JCO.2025.43.4_suppl.440