eligibility_summary
Eligibility: 18–75, advanced cancer post/ineligible for standard care, ECOG 0–1, >3 mo survival, adequate organs, RECIST lesion. Tumor tissue for CLDN18.2 preferred/required in expansion. Contraception, consent. Exclude: recent malignancy, high GI bleed risk, serious lung disease, unresolved AEs, recent surgery/thrombosis, uncontrolled illness, therapy <4 wks, prior CLDN18.2 drugs, vessel invasion, uncontrolled effusions, CNS mets, live vaccine <28 d, severe mAb allergy, or other unsafe conditions.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05867563: Phase 1, single-arm dose escalation/expansion in advanced cancers testing TQB2103, an antibody‑drug conjugate (ADC). Drug/intervention: TQB2103 for injection—humanized anti‑CLDN18.2 monoclonal antibody linked via a cleavable linker to a cytotoxic payload (DDDXD), with a drug–antibody ratio of 8, given IV every 3 weeks (0.5–5.0 mg/kg). Mechanism of action: the antibody binds claudin 18.2 on tumor cells, the ADC is internalized, the linker is cleaved intracellularly, and the released cytotoxic agent kills the cancer cell. Cells/pathways targeted: CLDN18.2‑expressing tumor cells, CLDN18.2 is a tight junction claudin family protein on epithelial cancer cells. The ADC does not target a signaling kinase pathway, it delivers a cytotoxic payload selectively to CLDN18.2‑positive cells.