Yantai, China, May 30, 2026 -- Boan Biotech today presented the updated data of a Phase I clinical trial for its BA1301, an investigational antibody-drug conjugate (ADC) targeting CLDN18.2, at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. BA1301 demonstrated promising signs of efficacy and a good safety profile in an expanded cohort of patients with advanced solid tumors.
CLDN18.2 is a transmembrane protein involved in regulating the tight junctions between epithelial cells. The protein is expressed in various solid tumors, including gastric, pancreatic, biliary tract, and ovarian tumors1, making it a high-potential target for cancer treatment in precision medicine. Developed by Boan Biotech, BA1301 uses the C-Lock site-specific conjugation method to link a tubulin inhibitor payload, Duostatin-5, with a CLDN18.2-targeting monoclonal antibody. This enables the precise delivery of the cytotoxic payload to tumors, exerting anti-tumor activity while reducing off-target toxicity and widening the therapeutic window. In addition, the bystander effect of the ADC further enhances its efficacy against heterogeneous tumors, such as gastric tumors.
The study presented at this year’s ASCO Annual Meeting is a first-in-human, multicenter, open-label Phase I clinical trial encompassing a dose-escalation phase and a dose-expansion phase. It is designed to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of BA1301 as a monotherapy in patients with advanced solid tumors. As of the data cutoff date of December 22, 2025, 91 patients had received at least one dose of BA1301. Key findings are as follows:
• BA1301 demonstrated potential in treating multiple types of solid tumors, including gastric and biliary tract tumors. In patients with medium-to-high CLDN18.2 expression treated with BA1301 at doses ≥1.6 mg/kg, the objective response rate (ORR) reached 29% for gastric cancer, 30% for biliary tract cancer, 14% for pancreatic cancer, and 33% for gynecological malignancies. Notably, one patient with biliary tract cancer achieved a partial response (PR) who had received the treatment for more than 16 months and is still receiving the treatment.
• BA1301 exhibited good safety and tolerability. Incidences of hematological and gastrointestinal adverse events and their severity were low. Treatment-related anemia and decreased neutrophil counts (≥Grade 3) occurred in 4.4% and 2.2% of the patients, respectively. Treatment-related vomiting and nausea (≥Grade 3) occurred in 3.3% and 2.2% of the patients, respectively. Treatment-related serious adverse events (SAE) occurred in 14.3% of the patients, and no treatment-related deaths were observed.
• BA1301 demonstrated excellent molecular stability enabled by C-Lock site-specific conjugation. At a dose of 2.0 mg/kg, the area under the curve (AUC) for Duostatin-5 was approximately 0.002% of the total antibody and 0.005% of the intact ADC. This indicated low payload dissociation in plasma and robust molecular stability in circulation, further confirming the superiority of the conjugation method.
The above-mentioned clinical trial remains ongoing. In addition, the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to BA1301 for the treatment of gastric cancer (including gastroesophageal junction adenocarcinoma) and pancreatic cancer.
“The updated data presented at the ASCO Annual Meeting provides further evidence for the efficacy of BA1301 against multiple types of CLDN18.2-positive solid tumors,” said Jiang Hua, Chairlady and Chief Executive Officer of Boan Biotech. “Importantly, enabled by its C-Lock site-specific conjugation technology, BA1301 has demonstrated promising antitumor activity and a differentiated hematologic and gastrointestinal safety profile among CLDN18.2-targeted ADCs. We will continue to develop innovative therapies on our ADC platform hoping to provide better options for patients worldwide.”
Boan Biotech is refining its proprietary ADC platform. On this platform, it is developing novel potent payloads, including dual-payload ADCs, and also experimenting on the use of techniques such as site-specific glycan conjugation. These innovations help address tumor heterogeneity, overcome drug resistance, and widen the therapeutic window. The company has developed multiple investigational ADCs on this platform. In addition to BA1301, the portfolio also includes BA1302 (an anti-CD228 ADC) and BA1304 (a bispecific ADC targeting EGFR and B7-H3).
1. Jeon H, Sterpi M, Mo C, et al. Claudins: from gatekeepers of epithelial integrity to potential targets in hepato-pancreato-biliary cancers. Front Oncol. 2024;14:1454882.
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