Preclinical characterization and phase I results of TQB2102, a first-in-class HER2 biparatopic antibody-drug conjugate, in patients with advanced solid tumors.
Ann OncolMay 15, 2026 (epub)
Clinical ResearchOncology (Medical)
D Y Ruan, S Y Lin, J J Huang et al.
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In 30 seconds
This phase I multicenter trial evaluated TQB2102, a biparatopic antibody-drug conjugate targeting HER2, in patients with advanced solid tumors. Among 195 enrolled patients, the recommended phase II dose was established at 6.0 mg/kg and 7.5 mg/kg. The objective response rate was 52.4% in metastatic breast cancer patients, indicating promising efficacy.
Key findings
- No dose-limiting toxicities were observed, and the maximum tolerated dose was not reached.
- The objective response rate was 52.4% in patients with HER2-positive metastatic breast cancer.
- Common grade ≥3 treatment-related adverse events included decreased neutrophil count (23.2%) and anemia (8.8%).
- Patients with HER2-low metastatic breast cancer achieved an objective response rate of 47.2%.
Why it matters
The findings suggest that TQB2102 has a manageable safety profile and shows preliminary efficacy in treating advanced solid tumors, particularly in HER2-positive and HER2-low metastatic breast cancer, which may influence future treatment strategies.