ESMO presentation
Innovent Biologics said it presented the first international Phase 1 clinical data for IBI3001, which the company describes as a first-in-class EGFR/B7H3 bispecific antibody-drug conjugate, in a Proffered Paper session at the 2026 European Society for Medical Oncology Congress. The abstract number was 1001O. The multicenter study was conducted in China, Australia and the United States and was designed to evaluate safety, tolerability and preliminary efficacy in patients with advanced solid tumors, the company said.
Safety in 57 patients
As of the data cutoff, 57 patients with advanced solid tumors had received IBI3001 monotherapy at doses from 1 mg/kg to 10 mg/kg. The group included 21 patients with non-small cell lung cancer, 15 with pancreatic cancer, eight with small cell lung cancer and 13 with other tumors; 78.9% had received at least two prior treatments. Innovent reported one dose-limiting toxicity in each of the 8 mg/kg and 10 mg/kg cohorts, all of which were managed. Grade 3 or higher treatment-related adverse events occurred in 47.4% of patients, the most common being hematologic toxicities, and one participant (1.8%) discontinued treatment permanently because of a treatment-related adverse event. No treatment-related deaths occurred, the company said.
Response rates
Among 53 efficacy-evaluable patients, the overall response rate was 30.2% and the disease control rate was 88.7%. In the 8 mg/kg cohort, the overall response rate was 45.0% and the disease control rate was 100%. In 16 patients with EGFR-mutant non-small cell lung cancer, the overall response rate was 31.3%, the disease control rate was 93.8% and median progression-free survival was 7.7 months. In 15 patients with pancreatic cancer, the overall response rate was 15.4%, the disease control rate was 92.3% and median progression-free survival was 6.9 months. In eight patients with small cell lung cancer, the overall response rate was 62.5% and the disease control rate was 100%. In five patients with head and neck squamous cell carcinoma or esophageal squamous cell carcinoma, the overall response rate was 60.0% and the disease control rate was 100%.
Next stage
Innovent said IBI3001 has advanced to the dose-optimization stage of a Phase 1b proof-of-concept study, with plans to further validate its efficacy and safety in later-line refractory cancer populations. Dr. Hui Zhou, the company's chief R&D officer for the oncology pipeline, said the Phase 1 data support the potential of its bispecific ADC platform and that the company will continue dose-optimization and cohort-expansion studies.