Safety and efficacy of HB0025, an anti-PD-1/VEGF bispecific antibody fusion protein, in patients with advanced solid tumors: Preliminary results from an FIH trial.

• DOI: 10.1200/jco.2023.41.16_suppl.2589
• Publication Date: 2023-06-04T15:12:10Z
• Authors: Yiqun Du; Jian Zhang; Meili Sun; Qing Wen; Yawen Zheng; Anthony W. Tolcher; David Sommerhalder; Zhen Wang; Xiumin Li; Zhenyuan Gao; Huan Zhou; Lian Liu; Benjie Wang; Xiangyang Zhu; Yongmin Yang; Yang Yang; Chao Li; Jiangfeng Li
• Keywords: Pharmacodynamics

2589 Background: HB0025 is a recombinant humanized anti-PD-L1 monoclonal antibody-VEGFR1 fusion Protein. Nonclinical data both in vitro and vivo have shown high-affinity binding to targets as well the inhibition of tumor growth animal models. Here, we present preliminary safety efficacy from dose escalation phase I study HB0025. Methods: Eligible patients(pts) were ≥18 years old (ECOG PS 0–1) who had advanced solid tumors (NSCLC, gynecological tumors, digestive system etc.) failed standard treatment. This 1 includes accelerated titration (0.01, 0.03, 0.1 0.3mg/kg) conventional 3+3 (1.0, 3.0, 6.0, 10, 12, 20, 30.0 mg/kg). administered intravenously every 14 days (Q2W). Objectives include evaluation safety, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, antitumor activity. Adverse events (AEs) reported with CTCAE v5.0 DLTs evaluated within 28-day window. Results: As Aug 30th 2022, 30 pts including 8 male 22 female Caucasian Mongoloid received at doses 0.01 mg/kg (n=1), 0.03 (n=2), 0.3 (n=1),1.0 (n=3), 3.0 (n=7), 6.0mg/kg 10.0 (n=5), 12.0mg/kg (n=3) Q2W. Overall, median age was 55 lines previous treatment four. Of evaluable dosed ≥ 3 Q2W, ORR 9.1% (2/22) disease control rate (DCR) 50% [11/22]. Among 2 responders, CR (colorectal ca) pt whose prior therapy no immune checkpoint inhibitor (ICI) or bevacizumab continued more than 36 weeks; PR (NSCLC) duration 18 weeks 60.2% regression ICI failure. Till date submission, continuing for pts. Treatment-related adverse (TRAEs) occurred 83.3% The grade TRAEs 20% [6/30] treatment-related SAEs 13.3% [4/30]. One DLT cohort. No death related leading discontinuation most frequent hypertriglyceridemia (23.3%), hypercholesterolemia anemia (16.7%), alanine aminotransferase increase proteinuria (13.3%). Conclusions: shows manageable promising anti-tumor activity various tumors. To better characterize risk-benefit profile, currently enrolled 20.0 Q2W being explored 10 expansion cohorts. future data, PK, PD ADA will be presented. Clinical trial information: NCT04678908 .