PO.CL07.05 · 临床研究

CVL006（一种新型PD-L1/VEGF双特异性抗体）治疗晚期实体瘤的开放标签、多中心I期临床研究

An open-label, multicenter Phase I clinical study of CVL006, a novel PD-L1/VEGF bispecific antibody, in advanced solid tumors

编号 2666 展板 18 时间 4/20 09:00–12:00 区域 Section 49 主讲 Steve Shen, PhD

分会场 Targeted Antigen Therapies and Immunity

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作者与单位 Authors & Affiliations

Jin Li¹, Ning Li², Shuhang Wang², Ye Guo³, Kai Yao⁴, Yanjie Zhu⁵, Feng Ye⁶, Hao Zeng⁷, Steve Shen⁸, Jin Zhang⁵

¹Shanghai GoBroad Cancer Hospital China Pharmaceutical University, Shanghai, China,²Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China,³Shanghai East Hospital, Shanghai, China,⁴Sun Yat-sen University Cancer Center, Guangzhou, China,⁵Renji Hospital, Shanghai Jiao Tong University School of Medical, Shanghai, China,⁶The First Affiliated Hospital of Xiamen University, Xiamen, China,⁷West China Hospital, Sichuan University, Chengdu, China,⁸Convalife Pharmaceuticals, Shanghai, China

摘要 Abstract

中文摘要

背景：CVL006是一种新型双特异性抗体，旨在通过同时阻断两条机制上不同的通路——VEGF/VEGFR信号和PD-L1/PD-1轴，实现协同抗肿瘤活性。在这项CVL006的开放标签、多中心I期临床研究中，将在患有晚期实体瘤的成年受试者中评估安全性、药代动力学（PK）和初步疗效，从而确定推荐的II期剂量（RP2D）（NCT06621615）。方法：本研究中所有受试者每2周（Q2W）接受一次CVL006。主要目标是评估安全性、耐受性以及以客观缓解率（ORR）衡量的临床疗效。结果：截至2025年11月14日数据截止日，29例患有各种晚期实体瘤的受试者接受了0.03-20 mg/kg的CVL006，其中Ia期12例，Ib期7例，Ic期10例。Ia期和Ib期已完成，Ic期正在进行中。Ia期结果显示CVL006耐受性良好，未达到MTD，RP2D为20 mg/kg。所有这些不良事件（AE）在对症治疗后均恢复。在20 mg/kg剂量组，CVL006表现出线性药代动力学和低ADA阳性发生率。18例受试者至少接受了一次疗效评估。在10 mg/kg剂量组（N=3），首次出现2例伴病灶缩小的疾病稳定（SD）。在20 mg/kg剂量下，对9例不同肿瘤类型的受试者进行了疗效评估，9例中有6例产生应答：4例SD和2例部分缓解（PR）。结论：CVL006单药治疗在晚期实体瘤患者中似乎耐受性良好，并具有令人鼓舞的初步疗效，值得进一步研究。

查看英文原文 English abstract

Background: CVL006 is a novel bispecific antibody designed for synergic antitumor activity by simultaneously blocking two mechanistically distinct pathways VEGF/VEGFR signaling and the PD-L1/PD-1 axis. In this Open-label, Multicenter Phase I Clinical Study of CVL006, Safety, pharmacokinetics (PK) and preliminary efficacy will be assessed in adult subjects with advanced solid tumors, and, thus, the recommended phase II dose (RP2D) will be established (NCT06621615). Method: All subjects in this study received CVL006 every 2 weeks (Q2W). Primary objectives were to evaluate safety, tolerability, and clinical efficacy by objective response rate (ORR). Results: As of the data cutoff date of Nov 14, 2025, 29 subjects with various advanced solid tumors received CVL006 at 0.03-20 mg/kg, 12 subjects in phase Ia, 7 subjects in phase Ib and 10 subjects in phase Ic. Phase Ia and phase Ib were completed and Phase Ic is ongoing. Phase Ia results show that CVL006 is well-tolerate, MTD has not reached, and RP2D is 20 mg/kg. All these AEs were recovered after symptomatic treatment. In the 20 mg/kg dose group, CVL006 showed linear pharmacokinetics and a low incidence of ADA positivity.18 subjects had at least one efficacy assessment. In the 10 mg/kg dose group (N=3), 2 stable disease (SD) cases with lesion shrinkage first appeared. At dose of 20 mg/kg, 9 subjects with different tumour types, were evaluated for efficacy and 6 of 9 subjects had a response : 4 SD and 2 partial response (PR). Conclusion: CVL006 monotherapy appeared to be well tolerated and had encouraging preliminary efficacy in patients with advanced solid tumors, warranting further investigation.

利益披露 Disclosure

J. Li, None.. N. Li, None.. S. Wang, None.. Y. Guo, None.. K. Yao, None.. Y. Zhu, None.. F. Ye, None.. H. Zeng, None.. S. Shen, None.. J. Zhang, None.

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