Innovent Biologics, Inc., a leading biopharmaceutical company focused on developing and commercializing innovative therapies, has announced a significant milestone. The results of its Phase 1 clinical study of IBI343, an advanced anti-CLDN18.2 antibody-drug conjugate (ADC) targeting gastric and gastroesophageal junction (G/GEJ) adenocarcinoma, have been published in Nature Medicine, a prestigious international academic journal.
This publication not only underscores the global scientific community’s recognition of IBI343’s clinical potential but also represents a key achievement for China in advancing novel anti-tumor therapeutics.
A Closer Look at the Study and Its Impact
Gastric cancer remains a major global health burden. According to GLOBOCAN 2022, it ranks as the fifth most common malignancy and the fifth leading cause of cancer-related deaths worldwide, with approximately 970,000 new cases and 660,000 deaths annually. China alone accounts for 37% of global cases and nearly 40% of deaths, highlighting a critical unmet medical need.
The Phase 1 study (ClinicalTrials.gov identifier: NCT05458219) was designed to evaluate the safety, tolerability, and preliminary efficacy of IBI343 in patients with advanced solid tumors. Between October 2022 and June 2024, 116 patients were enrolled—108 in dose expansion and 8 in dose escalation cohorts. Notably, IBI343 demonstrated promising activity in advanced G/GEJ adenocarcinoma, paving the way for further development.
Building on these results, Innovent has already launched a regional Phase 3 clinical trial (G-HOPE-001, NCT06238843) in 2024 to further evaluate IBI343’s potential as a treatment option for advanced G/GEJ adenocarcinoma patients.
Key Findings and Future Outlook
The Phase 1 trial showed encouraging safety and efficacy outcomes. Based on the pharmacokinetics (PK), safety profile, and visible clinical responses, the study identified 6 mg/kg every three weeks (Q3W) as the recommended Phase 2 dose (RP2D).
These results position IBI343 as a highly promising therapeutic option for patients with advanced gastric and gastroesophageal junction cancers, addressing a critical gap in treatment availability.
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