eligibility_summary
Adults (>=18) with measurable, advanced/unresectable or metastatic epithelial solid tumors progressed after standard therapy (e.g., HER2- GC/GEJ, TNBC or HR+HER2- BC, CRC, gynecologic, BTC, HNSCC, pancreatic). ECOG 0-1, adequate organ function, tumor tissue, contraception, and washout required. Exclude: pregnancy, active brain mets, serious cardiac/respiratory/GI disease, active infections (HBV/HCV/HIV/TB/COVID), prior Trop-2 or topo I ADC, unresolved AEs, recent live vaccine.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT06464055 tests GQ1010, an anti–Trop-2 antibody-drug conjugate (ADC). Type: targeted biologic (humanized monoclonal antibody linked to a cytotoxic payload). Mechanism: the antibody binds the cell-surface antigen Trop-2 (TACSTD2) on epithelial-derived solid tumors, is internalized, and releases an intracellular cytotoxic payload to induce tumor cell death (payload type not specified). Targeted cells/pathways: Trop-2–expressing tumor cells, leverages Trop-2 overexpression for selective delivery, disrupting tumor cell survival pathways and provoking apoptosis. Indications include advanced gastric/GEJ, breast (TNBC and HR+HER2−), colorectal, gynecologic (ovarian, endometrial, cervical), biliary tract, head & neck SCC, and pancreatic cancers. Design: first-in-human, open-label Phase I/II dose escalation/expansion (IV q14–21 days) assessing safety, PK, immunogenicity, and preliminary efficacy, Trop-2 expression is not required for enrollment.