What question did this study set out to answer?

The study aims to assess the safety, pharmacokinetics, and preliminary efficacy of CVL006 in adults with advanced solid tumors.

April 5, 2026

Abstract 2666: An open-label, multicenter Phase I clinical study of CVL006, a novel PD-L1/VEGF bispecific antibody, in advanced solid tumors

Key Points

The study aims to assess the safety, pharmacokinetics, and preliminary efficacy of CVL006 in adults with advanced solid tumors.
Conducted as an open-label, multicenter Phase I clinical trial.
Subjects received CVL006 every 2 weeks with doses ranging from 0.03-20 mg/kg.
Primary objectives included evaluating safety, tolerability, and objective response rates.
CVL006 was well-tolerated with no maximum tolerated dose reached; the recommended phase II dose is 20 mg/kg.
At 20 mg/kg, 6 out of 9 evaluable subjects showed clinical responses, including 4 with stable disease and 2 with partial responses.
Linear pharmacokinetics observed at the 20 mg/kg dose and low incidence of adverse drug antibody positivity.

Abstract

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. Citation Format: Jin Li, Ning Li, Shuhang Wang, Ye Guo, Kai Yao, Yanjie Zhu, Feng Ye, Hao Zeng, Steve Shen, Jin Zhang. An open-label, multicenter Phase I clinical study of CVL006, a novel PD-L1/VEGF bispecific antibody, in advanced solid tumors abstract. In: Proceedings of the American Association for Cancer Research Annual Meeting 2026; Part 1 (Regular Abstracts); 2026 Apr 17-22; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2026;86(7 Suppl):Abstract nr 2666.

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Abstract 2666: An open-label, multicenter Phase I clinical study of CVL006, a novel PD-L1/VEGF bispecific antibody, in advanced solid tumors

Key Points

Abstract

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