eligibility_summary
Adults 18-75 with advanced solid tumors. Escalation: no standard options. Expansion: HER2-low breast, HER2+ GI (excl pancreatic/biliary), HER2+ gynecologic, other HER2+ tumors (incl >=10 breast, NSCLC). Requires measurable RECIST lesion, tissue (expansion), ECOG 0, >=3-mo survival, adequate organs, contraception, consent. Exclude protocol-specified tumors/treatments, active HBV/HCV/syphilis, symptomatic effusions, uncontrolled disease, ILD, recent severe infection/IV antibiotics, recent trial, serious comorbidities/allergies, pregnancy, PI discretion.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: SIBP-A17, an anti-HER2 antibody–drug conjugate (ADC) given IV every 21 days (1–8 mg/kg). Mechanism: a monoclonal antibody targets HER2 (ERBB2) on tumor cells, is internalized, and releases a cytotoxic payload inside the cell to induce tumor cell death, payload type not disclosed. Targets: HER2-expressing solid tumors, including HER2-low breast cancer (IHC1+ or IHC2+/FISH−) and HER2-positive (IHC3+ or IHC2+/FISH+) digestive and gynecologic cancers, plus other HER2+ tumors. Pathway/cell focus: HER2/ERBB2 receptor tyrosine kinase on tumor cell membranes, effect is direct tumor cytotoxicity following HER2-mediated uptake. Design: open-label, multicenter Phase I dose escalation/expansion to define MTD/RP2D and assess safety, PK, immunogenicity, QTc, and preliminary efficacy. Status: recruiting in China.