A phase Ia trial to evaluate the safety and efficacy of HB0030, an anti-TIGIT antibody, in patients with advanced solid tumors: Preliminary results.

• DOI: 10.1200/jco.2023.41.16_suppl.e14673
• Publication Date: 2023-06-04T15:12:51Z
• Authors: Huan Zhou; Wei Li; Jing Xie; Hongtao Li; Xiangyang Zhu; Yongmin Yang; Yang Yang; Yang Zheng; Qiaofeng Wang; Juan Chen; Chao Li; Ruirui Xu; Jingjing Wang; Yiran He
• Keywords: TIGIT

e14673 Background: HB0030 is an IgG1 type humanized monoclonalanti-TIGIT antibody. Its heavy chain Fc fragment wild-type that preserves function for inducting CDC and ADCC effects. Nonclinical data showed has a good affinity TIGIT anti-tumor activity. Methods: This ongoing single-center, open-label, dose escalation Phase Ia study to mainly evaluate safety, antitumor activity immunogenicity in patients (pts) with advanced solid tumor. administered by IV infusion every 21 days. An accelerated titration method combined the standard 3+3 design was utilized escalation, which of contained 8 groups (0.1, 0.3, 1.0, 3.0, 10, 20, 30, 40mg/kg). The tumor assessment evaluated investigator according RECIST v1.1. Results: As Jan 9, 2023, 20 pts (4Male/16Female) malignant have been enrolled dosed at 0.1mg/kg (n = 1), 0.3mg/kg 3), 1mg/kg 3mg/kg 4), 10mg/kg 3) 20mg/kg 6). median age 56.9 years. All had stage disease failed from therapy 3 lines. main types included lung(n 6), breast(n colorectal(n cervical 2) cancer. Total 16 completed least once assessment. ORR DCR were 6.3% (1/16) 62.5% (10/16), respectively. best response PR 47% regression pt who diagnosed non-small cell lung cancer (NSCLC) accompanied TP53 gene mutation. relapsed multiple metastasis after radical operation adjuvant chemotherapy, systemic chemotherapy targeting anti-vascular therapy. He achieved cycles treatment, status continued present. A NSCLC maintained 24 weeks SD administration. most common treatment related adverse events (TRAEs) lymphopenia (9/20, 45%) shortened activated partial thromboplastin time (APTT) (6/20,30%). Grade TRAEs occurred 15% (3/20) thrombocytopenia, anemia, syncope hypertension. There no 4-5 AEs, serious (SAEs), dose-limiting toxicity (DLT) death. anti-drug antibodies (ADAs) detected 2 mg/kg group, not caused because it existed baseline. Conclusions: very well safety 0.1 mg/kg, potential promising above tumors pts, especially NSCLC. Currently, 30mg/kg 40mg/kg are ongoing. Clinical trial information: NCT05706207 .