Sino Biopharmaceutical Limited (SBP Group) presented first-in-human Phase I results for its EGFR/c-Met antibody–drug conjugate (ADC) TQB6411 at the 2026 American Society of Clinical Oncology Annual Meeting.
A total of 26 patients with advanced solid tumours were enrolled (median age 60; 46.2% female). The cohort included 21 cases of non-small cell lung cancer (NSCLC), three esophageal cancers and two colorectal cancers, all of which had progressed after at least one prior systemic regimen.
Dose escalation progressed from 0.8 mg/kg to 6.6 mg/kg without dose-limiting toxicities. Among nine patients treated at ≥4.0 mg/kg who underwent imaging evaluation, four achieved partial responses, translating into an objective response rate of 44.44 % and a disease control rate of 100 %. Notable tumour regressions included a 55.2 % reduction in one NSCLC patient at 5.3 mg/kg and tumour-shrinkage of 30.4 % and 48.1 % in two heavily pre-treated NSCLC patients at 4.0 mg/kg.
Safety observations were manageable. In 23 patients followed for at least 21 days, Grade 3 treatment-related adverse events occurred in 21.74 %, with no Grade ≥4 events and no reported interstitial lung disease. The company highlighted low haematological toxicity across dose levels.
TQB6411 is designed with higher binding affinity for c-Met than EGFR (potency ratio 1:2), a feature intended to enhance activity against tumours with high c-Met expression while reducing EGFR-related adverse effects such as skin toxicity. SBP Group stated it is accelerating clinical development based on the favourable efficacy and safety profile demonstrated in this early study.
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