eligibility_summary
Eligible: adults ≥18 with advanced incurable malignancy progressed after ≥1 standard therapy, ECOG 0–1, life expectancy ≥12 weeks, adequate hematologic/end‑organ function, tumor specimen available, measurable disease (RECIST 1.1). Exclude: other cancers <2 yrs, primary/active CNS disease, ILD/pneumonitis/pneumonia, severe antibody hypersensitivity, autoimmune disease, HIV+, severe infection, major CV disease, prior allogeneic transplant/GVHD, significant liver disease.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: SIM0348 monotherapy and SIM0348 + sintilimab. Drug types/mechanisms: SIM0348 is a first‑in‑human, IV investigational immunotherapy, its precise target/mechanism and drug class are not disclosed in the registry (PK/PD and preliminary antitumor activity are being characterized). Sintilimab is a human IgG4 monoclonal antibody immune checkpoint inhibitor that blocks PD‑1, preventing PD‑1/PD‑L1 interaction to restore antitumor T‑cell function. Targeted cells/pathways: Sintilimab targets PD‑1 on effector/exhausted T cells, modulating the PD‑1/PD‑L1 checkpoint signaling axis in the tumor microenvironment. SIM0348’s specific cellular targets/pathways are not specified in this record.