eligibility_summary
Eligible: unresectable/locally advanced or metastatic solid tumors, refractory/relapsed or ineligible/refusing standard therapy, allow archival tissue, washout (chemo ≥ last cycle or ≥2w, nitrosourea/mitomycin 6w, biologic ≥3w, small molecules ≥5×t½), ECOG 0–1, adequate organs, LVEF ≥50%, contraception. Exclude: unresected primary CRC, predominant squamous NSCLC, unstable CNS mets, unresolved ≥G2 AEs, vasculitis, ≥G2 ocular issues, variceal risk, other anticancer therapy, uncontrolled disease/infection, major surgery <3w, RT <2w, recent 2nd malignancy, significant CV disease, non-switchable potent CYP3A meds, pregnancy/breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT06440005 tests AGX101, a TM4SF1-directed antibody–drug conjugate (ADC). Drug/intervention: AGX101 (intravenous ADC). Mechanism: A monoclonal antibody binds TM4SF1 on target cells, is internalized, and releases a linked cytotoxic payload to induce cell death. As TM4SF1 is enriched on tumor endothelial cells and many solid tumor cells, AGX101 is designed for dual activity—direct tumor cell killing and vascular targeting that may disrupt tumor angiogenesis/blood supply. Targets: TM4SF1 (a tetraspanin-like surface protein) on tumor cells and tumor-associated endothelial cells, pathways related to tumor vasculature/angiogenesis and TM4SF1-mediated tetraspanin complexes. Phase: First-in-human dose escalation/expansion in advanced solid tumors, with an angiosarcoma expansion cohort.