eligibility_summary
Adults ≥18 with PD-L1-positive metastatic NSCLC, SCLC, TNBC, melanoma, HNSCC, or endometrial cancer, progressed after/unsuitable for SOC (any prior lines), ≥1 RECIST lesion, ECOG ≤2, life expectancy ≥4 mo, WOCBP/men use contraception, stable treated brain metastases allowed, Phase I: 177Lu-RAD204im positive. Exclude prior transplant, other active cancer, ≥G2 residual toxicity, hypersensitivity, organ dysfunction, transfusion, major CV disease, other trials, pregnancy, recent surgery/therapy, severe irAEs on PD-(L)1, HIV, active HBV/HCV, high-risk illnesses/infections.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: 177Lu-RAD204, a lutetium-177–labeled anti–PD-L1 single-domain antibody (sdAb, nanobody) radiopharmaceutical/theranostic. Mechanism: the sdAb binds PD-L1 on tumor and immunosuppressive cells, the 177Lu payload delivers targeted beta radiation that induces DNA damage and cell death, while gamma emissions enable SPECT/CT imaging for biodistribution and dosimetry. Although PD-1/PD-L1 interaction may be blocked by binding, the primary intent is targeted radioligand therapy. Targets: PD-L1 pathway and PD-L1–expressing cells within PD-L1–positive solid tumors (NSCLC, SCLC, TNBC, melanoma, HNSCC, endometrial). Aims: assess safety, tolerability, biodistribution, dosimetry, and preliminary anti-tumor activity, define MTD/recommended dose in a Phase 0/1 single-arm dose-escalation study.