A phase 2 study of sacituzumab govitecan with or without atezolizumab in rare genitourinary tumors (SMART) – design and rationale

作者：Andre R. Kydd, Elias Chandran, Nicholas I. Simon, Saad Atiq, Lisa Ley, Tzu-Fang Wang, Lisa M. Cordes, Ruchi P. Patel, Elizabeth Smith, Salah Boudjadi, Scot A. Niglio, Abbas Yousefi-Rad, Sally Weng, Ian Stukes, Abdul Rouf Banday, Dilara Akbulut, Sandeep Gurram, Bernadette Redd, Seth M. Steinberg, Hyoyoung Choo‐Wosoba, Andrea B. Apolo · 发表于：Future Oncology · 年份：2025 · DOI：10.1080/14796694.2025.2516901 · 被引用次数：6 · 研究领域：Ovarian cancer diagnosis and treatment、Genital Health and Disease、Renal cell carcinoma treatment

Sacituzumab govitecan (SG) is a TROP2-directed antibody–drug conjugate with a payload of SN-38, a topoisomerase inhibitor. SG monotherapy has demonstrated activity in multiple solid tumors, including metastatic breast and bladder cancer. Rare tumors of the genitourinary tract often exhibit aggressive clinical behavior yet lack effective treatment options. This article describes the design and rationale for an open-label, non-randomized, phase 2 trial of SG monotherapy or concomitant SG plus atezolizumab in locally advanced/metastatic bladder/urinary tract adenocarcinoma/urachal adenocarcinoma, squamous cell carcinoma, or high-grade neuroendocrine carcinoma; renal medullary carcinoma; and penile squamous cell carcinoma.Clinical Trial Registration: NCT06161532 (ClinicalTrials.gov)