Phase 1a study of ESG401, a Trop2 antibody-drug conjugate, in patients with locally advanced/metastatic solid tumors.

IF 11.7 1区医学 Q1 CELL BIOLOGY Cell Reports Medicine Pub Date : 2024-09-17 Epub Date: 2024-08-30 DOI:10.1016/j.xcrm.2024.101707

Jiani Wang, Zhongsheng Tong, Yinuo Tan, Yehui Shi, Yun Wu, Qing Zhou, Xiaoyan Xing, Xiaomei Chen, Fuming Qiu, Fei Ma

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Abstract

This phase 1a study assesses ESG401 in patients with heavily pretreated locally advanced or metastatic solid tumors, focusing on metastatic breast cancer. Forty patients are enrolled: three experience dose-limiting toxicities, establishing the maximum tolerated dose at 16 mg/kg on days 1, 8, and 15 of a 28-day cycle. The most common grade ≥3 treatment-related adverse events are neutropenia and leukopenia. Among 38 efficacy-evaluable patients, the objective response rate (ORR) is 34.2%, the disease control rate (DCR) is 65.8%, and the clinical benefit rate (CBR) is 50.0% (including stable disease for at least 6 months). The median progression-free survival is 5.1 months, and the median duration of response is 6.3 months. In patients receiving therapeutically relevant doses, the ORR, DCR, and CBR are 40.6%, 75.0%, and 56.3%, respectively. ESG401 demonstrates a favorable safety profile and promising antitumor activity in this heavily treated population. The trial is registered at ClinicalTrials.gov (NCT04892342).

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对局部晚期/转移性实体瘤患者进行 Trop2 抗体-药物共轭物 ESG401 的 1a 期研究。

这项 1a 期研究评估了 ESG401 对重度预处理局部晚期或转移性实体瘤患者的治疗效果，重点是转移性乳腺癌。40名患者入组：3名患者出现剂量限制性毒性反应，最大耐受剂量为16毫克/千克，28天周期的第1、8和15天。最常见的≥3级治疗相关不良反应是中性粒细胞减少和白细胞减少。在38名有疗效的患者中，客观反应率（ORR）为34.2%，疾病控制率（DCR）为65.8%，临床获益率（CBR）为50.0%（包括至少6个月的疾病稳定期）。中位无进展生存期为 5.1 个月，中位应答持续时间为 6.3 个月。在接受治疗相关剂量的患者中，ORR、DCR 和 CBR 分别为 40.6%、75.0% 和 56.3%。ESG401 在这一接受大量治疗的人群中表现出良好的安全性和抗肿瘤活性。该试验已在 ClinicalTrials.gov (NCT04892342) 上注册。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Cell Reports Medicine Biochemistry, Genetics and Molecular Biology-Biochemistry, Genetics and Molecular Biology (all)

CiteScore

15.00

自引率

1.40%

发文量

231

审稿时长

40 days

期刊介绍： Cell Reports Medicine is an esteemed open-access journal by Cell Press that publishes groundbreaking research in translational and clinical biomedical sciences, influencing human health and medicine. Our journal ensures wide visibility and accessibility, reaching scientists and clinicians across various medical disciplines. We publish original research that spans from intriguing human biology concepts to all aspects of clinical work. We encourage submissions that introduce innovative ideas, forging new paths in clinical research and practice. We also welcome studies that provide vital information, enhancing our understanding of current standards of care in diagnosis, treatment, and prognosis. This encompasses translational studies, clinical trials (including long-term follow-ups), genomics, biomarker discovery, and technological advancements that contribute to diagnostics, treatment, and healthcare. Additionally, studies based on vertebrate model organisms are within the scope of the journal, as long as they directly relate to human health and disease.