eligibility_summary
Adults (≥18) with biopsy-proven stage IV cancer (multiple types), refractory/progressive after ≥1 line or declined SOC, measurable disease, tumor available for sequencing, KPS ≥60, adequate blood/renal/liver function, neg pregnancy test, contraception, consent. Exclude: insufficient tissue, HIV, recent chemo/RT/live vaccines/steroids, investigational drugs, active autoimmune tx, recent symptomatic brain mets, serious organ dysfunction/illness, pregnancy/breastfeeding, inability to consent.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Trial: Phase 1, open-label, single-arm immunotherapy in Stage IV cancers. Drug/intervention: “Moonshot antibodies” — patient-specific chimeric monoclonal antibodies generated from each subject’s tumor. Targets are chosen via whole-exome and RNA sequencing to identify mutated cell-surface proteins (neoepitopes) absent from normal tissue. Mechanism of action: Antibodies bind mutated extracellular epitopes on tumor cells to enable immune-mediated killing, primarily via Fc-dependent effector functions (ADCC by NK cells, macrophage phagocytosis) and complement-dependent cytotoxicity (CDC), may also block oncogenic receptor signaling when relevant. Cells/pathways targeted: Tumor cells expressing mutated surface proteins, immune effector pathways include Fcγ receptor signaling on NK cells/macrophages and the complement cascade. Delivery: IV infusions. Primary aim: safety/feasibility.