eligibility_summary
Eligibility: Adults (≥18) with unresectable/metastatic, measurable non‑prostate GU cancer: HGNEC, bladder/urinary tract SCC or adenocarcinoma, renal medullary carcinoma, or penile SCC. Pre‑treatment tissue (~25 slides) or fresh biopsy, ECOG 0–1, adequate organ function. Prior therapy allowed with washouts, HGNEC bladder/UT needs prior platinum. Treated CNS mets and controlled HIV/HBV/HCV allowed. Exclude active autoimmune/ILD, severe CV disease, untreated CNS mets, recent live vaccine, major surgery, hypersensitivity.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II SMART (NCT06161532) tests sacituzumab govitecan (SG) alone or with atezolizumab in rare genitourinary cancers (high-grade neuroendocrine, bladder/urinary tract squamous or primary adenocarcinoma, renal medullary carcinoma, penile SCC). SG is an antibody-drug conjugate: an IgG1 anti-Trop-2 monoclonal antibody linked to SN-38 (irinotecan’s active metabolite), a topoisomerase I inhibitor. Binding to Trop-2 on tumor cells drives internalization and SN-38 release, causing DNA damage and cell death (with possible bystander effect). Atezolizumab is an anti-PD-L1 monoclonal antibody checkpoint inhibitor that blocks PD-L1 interactions with PD-1/B7.1, restoring cytotoxic T-cell activity. Targets/pathways: Trop-2-positive tumor cells, topoisomerase I, PD-1/PD-L1 axis on tumor and immune cells.