B7同源体3 (B7-H3; CD276) 是肿瘤相关抗原和可能的免疫检查站，在前列腺癌 (PCa) 中高度表达，并与早期复发和转移有关。Enoblituzumab 是一种人源化、Fc工程化、针对B7-H3的抗体，其介导的抗体依赖性细胞毒性。在这个第二阶段、生物标志物丰富的新辅助试验中，招募了32名可手术的中度到高危本地化PCa的生物男性，以评估在前列腺切除术之前给予enoblituzumab的安全性、抗肿瘤活性和免疫原性。共同主要结局为安全和在前列腺切除术后1年前无法检测到前列腺特异抗原 (PSA) 水平 (PSA0)，目标是获得合理精度的PSA0估计值。主要安全终点符合要求，没有明显的手术或医疗并发症或手术延误。总体而言，12%的患者出现了3级不良事件，没有出现4级事件。共同主要终点PSA0率在前列腺切除术后1年为66% (95%置信区间47-81%)。在PCa中使用B7-H3靶向免疫疗法是可行和一般安全的，初步数据表明具有潜在的临床活性。目前的研究验证了B7-H3作为PCa治疗发展的合理目标，计划进行更大规模的研究。ClinicalTrials.gov 标识符为NCT02923180。© 2023年。作者(们)独家许可Springer Nature America, Inc.使用。

B7 homolog 3 (B7-H3; CD276), a tumor-associated antigen and possible immune checkpoint, is highly expressed in prostate cancer (PCa) and is associated with early recurrence and metastasis. Enoblituzumab is a humanized, Fc-engineered, B7-H3-targeting antibody that mediates antibody-dependent cellular cytotoxicity. In this phase 2, biomarker-rich neoadjuvant trial, 32 biological males with operable intermediate to high-risk localized PCa were enrolled to evaluate the safety, anti-tumor activity and immunogenicity of enoblituzumab when given before prostatectomy. The coprimary outcomes were safety and undetectable prostate-specific antigen (PSA) level (PSA0) 1 year postprostatectomy, and the aim was to obtain an estimate of PSA0 with reasonable precision. The primary safety endpoint was met with no notable unexpected surgical or medical complications, or surgical delay. Overall, 12% of patients experienced grade 3 adverse events and no grade 4 events occurred. The coprimary endpoint of the PSA0 rate 1 year postprostatectomy was 66% (95% confidence interval 47-81%). The use of B7-H3-targeted immunotherapy in PCa is feasible and generally safe and preliminary data suggest potential clinical activity. The present study validates B7-H3 as a rational target for therapy development in PCa with larger studies planned. The ClinicalTrials.gov identifier is NCT02923180.© 2023. The Author(s), under exclusive licence to Springer Nature America, Inc.