尽管贝伐珠单抗对铂类耐药卵巢癌患者具有明显的无进展生存期（PFS）益处，但其使用仍因安全问题而受到阻碍，这凸显了对新型有效且安全的抗血管生成药物的需求。本研究旨在表征铂耐药卵巢癌患者中递增剂量的抗 VEGF 抗体 suvemcitug 联合化疗的耐受性、安全性和抗肿瘤活性。这项开放标签、剂量递增试验纳入了患有以下疾病的成年患者（≥18 岁）经组织学或细胞学证实的铂耐药的上皮性卵巢癌、输卵管癌和原发性腹膜癌。符合条件的患者每两周接受一次紫杉醇或托泊替康加 0.5、1、1.5 或 2 mg/kg 剂量的 suvemcitug 递增治疗。主要终点是 suvemcitug 的安全性和耐受性以及抗肿瘤活性。29 名受试者接受紫杉醇 (n = 11) 或拓扑替康 (n = 18) 治疗。没有发生剂量限制性毒性。最常见的特别令人关注的不良事件是蛋白尿（41.4%）、高血压（20.7%）和鼻出血（10.3%）。未发生胃肠道穿孔。 9 名受试者（31.0%，95% CI 15.3-50.8）表现出研究人员确认的客观缓解，其中 1 名受试者完全缓解，8 名受试者部分缓解。中位 PFS 为 5.4 个月（95% CI 2.2-7.4）。Suvemcitug 表现出可接受的水平在铂类耐药卵巢癌患者中的安全性和有前景的抗肿瘤活性，支持其进一步的临床开发。版权所有 © 2024 作者。由爱思唯尔公司出版。保留所有权利。

The use of bevacizumab has been hampered by safety concerns despite demonstrable progression-free survival (PFS) benefit in subjects with platinum-resistant ovarian cancer, highlighting the need for novel effective and safe antiangiogenic agents. This study aimed to characterize the tolerability, safety, and antitumor activities of escalating doses of anti-VEGF antibody suvemcitug plus chemotherapy in platinum-resistant ovarian cancer patients.This open-label, dose-escalation trial enrolled adult patients (≥18 years) with platinum-resistant histologically or cytologically-confirmed epithelial ovarian, fallopian tube and primary peritoneal cancer. Eligible patients received paclitaxel or topotecan plus escalating doses of suvemcitug 0.5, 1, 1.5, or 2 mg/kg once every two weeks. The primary endpoints were safety and tolerability, and antitumor activities of suvemcitug.Twenty-nine subjects received paclitaxel (n = 11) or topotecan (n = 18). No dose-limiting toxicities occurred. The most common adverse events of special interest were proteinuria (41.4%), hypertension (20.7%) and epistaxis (10.3%). No gastrointestinal perforations occurred. Nine subjects (31.0%, 95% CI 15.3-50.8) demonstrated investigators-confirmed objective response, including complete response in 1 and partial response in 8. The median PFS was 5.4 months (95% CI 2.2-7.4).Suvemcitug demonstrated an acceptable safety profile and promising antitumor activities in platinum-resistant ovarian cancer patients, supporting its further clinical development.Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.