eligibility_summary
Include: advanced/metastatic solid tumors (not primary brain/CNS), ≥1 measurable extracranial lesion, treated, stable brain mets (no progression ≥4 wks, neurologically stable, no new/enlarging lesions, off steroids ≥14 days), females non–childbearing. Exclude: prior TLR7/8 agonists, active/untreated CNS disease, cardiac dysfunction, significant infection, HIV/HBV/HCV, recent other malignancy, recent surgery/therapy, severe autoimmune/immunosuppression (>10 mg prednisone), prior transplant, study-drug hypersensitivity.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06302426 tests INI-4001, an IV small-molecule TLR7/8 agonist, as monotherapy and combined with checkpoint inhibitors: PD-1 monoclonal antibodies (nivolumab, pembrolizumab, cemiplimab) and PD-L1 monoclonal antibodies (avelumab, atezolizumab, durvalumab). Mechanism of INI-4001: activates TLR7/8 on innate immune cells (plasmacytoid and myeloid dendritic cells, monocytes/macrophages), engaging MyD88–NF-κB/IRF pathways to induce type I interferons and proinflammatory cytokines, enhance antigen presentation, activate NK cells, and prime tumor-specific T cells. Mechanism of ICIs: block PD-1/PD-L1 signaling to reverse T-cell exhaustion and restore cytotoxic T-cell function. Primary targets: TLR7/8 innate-sensing pathway, APCs and NK cells, PD-1 on T cells and PD-L1 on tumor/immune cells to boost adaptive anti-tumor immunity.