eligibility_summary
Adults (≥18) with metastatic, measurable CRC post/unable to receive ≥2 standard lines (FP+OX/IRI+bev, regorafenib, trifluridine, EGFR if RAS WT, CPI if MSI-H/dMMR) or relapse ≤6 mo post-adjuvant without systemic therapy. ECOG≤2, adequate labs, treated brain mets, controlled HIV/HCV OK. Contraception, stop breastfeeding, biopsies, consent. Exclude recent therapy/RT, autoimmune disease, ILD/pneumonitis, infection, transplant, severe irAEs, HBV, pregnancy, uncontrolled illness.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06149481 (STAR15) tests combination immunotherapy in metastatic colorectal cancer (largely MSS). Interventions and mechanisms: 1) Retifanlimab – humanized IgG4 monoclonal antibody (immune checkpoint inhibitor) blocking PD-1 to restore exhausted T‑cell function. Targets PD-1/PD-L1 pathway on T cells. 2) TriAdeno vaccine – adenoviral (Ad5) cancer vaccine encoding CEA, MUC1, and brachyury TAAs to prime/expand antigen-specific CD4+/CD8+ T cells via antigen presentation/TCR pathways. 3) N‑803 (ALT‑803) – IL‑15 superagonist cytokine biologic that activates and expands NK cells and memory/effector T cells via IL‑15/JAK‑STAT signaling. 4) SX‑682 – oral small‑molecule allosteric antagonist of CXCR1/2 that blocks CXCL8(IL‑8)–mediated trafficking/function of myeloid-derived suppressor cells and tumor-associated neutrophils/macrophages, reducing intratumoral T‑cell suppression. Arms: triple (retifanlimab+TriAdeno+N‑803) vs quadruple adding SX‑682.