eligibility_summary
Adults (≥18) with GPC3+ HCC (not fibrolamellar/sarcomatoid/mixed), BCLC B/C, measurable disease, after ≥1 ICI and ≥1 targeted therapy, ECOG 0–1, Child-Pugh ≤6, adequate marrow/liver/renal/cardiac function, consent. Exclude: active/untreated brain mets, recent anticancer/local/investigational therapy or surgery, transplant, >G1 unresolved AEs, significant cardiac/QTc or uncontrolled HTN, active infection or uncontrolled HBV/HCV or HIV+, immunosuppression/autoimmune, other recent cancers, pregnancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: MTS105 (biologic mRNA–lipid nanoparticle therapy). Mechanism: IV LNPs deliver mRNA to the liver, where it is translated into a bispecific T‑cell engager that binds hepatocellular carcinoma cells and activates endogenous T cells to kill tumor cells, designed for liver-targeted expression and potent antitumor activity. Targets (cells/pathways): GPC3-positive HCC cells (patient selection requires GPC3 by IHC), engages and activates T cells via a bispecific T‑cell engager mechanism, triggering T‑cell activation and cytotoxicity against tumor cells. Trial: First-in-human, Phase 1 dose-escalation (BOIN) in advanced HCC after failure of checkpoint inhibitor and targeted therapy.