Kydd Andre R, Chandran Elias, Simon Nicholas I, Atiq Saad, Ley Lisa, Wang Tzu-Fang, Cordes Lisa, Patel Ruchi, Smith Elizabeth, Boudjadi Salah, Niglio Scot A, Yousefi-Rad Abbas, Weng Sally, Stukes Ian, Banday A Rouf, Akbulut Dilara, Gurram Sandeep, Redd Bernadette, Steinberg Seth, Choo-Wosoba Hyoyoung, Apolo Andrea B
Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Laboratory of Pathology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Future Oncol. 2025 Aug;21(18):2261-2268. doi: 10.1080/14796694.2025.2516901. Epub 2025 Jun 23.
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. NCT06161532 (ClinicalTrials.gov).
戈沙妥珠单抗（SG）是一种靶向TROP2的抗体药物偶联物，其有效载荷为拓扑异构酶抑制剂SN-38。SG单药疗法已在多种实体瘤中显示出活性，包括转移性乳腺癌和膀胱癌。泌尿生殖道罕见肿瘤通常表现出侵袭性临床行为，但缺乏有效的治疗选择。本文描述了一项开放标签、非随机的2期试验的设计和原理，该试验采用SG单药疗法或SG联合阿替利珠单抗治疗局部晚期/转移性膀胱/尿道腺癌/脐尿管腺癌、鳞状细胞癌或高级别神经内分泌癌；肾髓质癌；以及阴茎鳞状细胞癌。NCT06161532（ClinicalTrials.gov）
