eligibility_summary
Eligibility: Adults 18–75, ECOG 0–1, life expectancy ≥12 weeks, hist/cyt confirmed locally advanced tumors (priority HER2+), progressed after/no standard therapy, ≥1 RECIST 1.1 evaluable lesion, adequate organ function, consent, effective contraception during and 6 months post. Exclude: concurrent secondary malignancy or other malignancy with NED >3y, uncontrolled illness, recent ≤4 wk therapy/procedures/investigational, symptomatic brain mets, severe mAb allergy, ILD/pneumonia, unstable serious conditions.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase I, single-arm study of TQB2102 injection, an antibody-drug conjugate (ADC). TQB2102 comprises a humanized anti-HER2 monoclonal antibody, an enzyme-cleavable linker, and a topoisomerase I inhibitor payload. Mechanism: the antibody binds HER2 on tumor cells, the ADC is internalized, the linker is cleaved intracellularly, and the released topo I inhibitor causes DNA damage, inhibiting replication and leading to cell death. Targets: HER2-overexpressing solid tumors, pathways include HER2 receptor–mediated endocytosis/trafficking and DNA topoisomerase I–dependent replication. Dosed IV every 3 weeks (1.5–9 mg/kg). Primary aim: safety/tolerability and preliminary efficacy.