drugset / Trial / NCT04085185
A Study Evaluating the Safety, Tolerability, and Initial Efficacy of IBI110 in Subjects With Advanced Malignant Tumors
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of IBI110 in subjects with advanced malignancies.
Timeline
- Start
- 2019-12-04
- Primary completion
- 2023-12-15
- Completion
- 2024-06-30
Publications
- Wang Q, Xiong A, Mao C, Wang W, Cui J, Fang J, Zhuang W, Yang K, Zuo W, Yang J, Ye L, Zhang Z, Sheng Z, Liu Z, Wang D, Du X, Yi T, Long S, Xu N, Zhou C. Efficacy and safety of anti-LAG-3 IBI110 in combination with sintilimab and chemotherapy for advanced squamous non-small cell lung cancer: a randomized phase II study. Cancer Immunol Immunother. 2026 Jan 27;75(2):56. doi: 10.1007/s00262-026-04299-x.
- Mao C, Xiong A, Qian J, Wang W, Liu Y, Zhang T, Wu Z, Ni H, Lu J, Long S, Zhao L, Chen Y, Zhou C, Xu N. Dual inhibition of LAG-3 and PD-1 with IBI110 and sintilimab in advanced solid tumors: the first-in-human phase Ia/Ib study. J Hematol Oncol. 2024 Dec 31;17(1):132. doi: 10.1186/s13045-024-01651-5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NEGALSTOBART | Monoclonal antibody | 0.01 mg/kg | Intravenous |
| Subject | NEGALSTOBART | Monoclonal antibody | 0.1 mg/kg | Intravenous |
| Subject | NEGALSTOBART | Monoclonal antibody | 0.3 mg/kg | Intravenous |
| Subject | NEGALSTOBART | Monoclonal antibody | 0.7 mg/kg | Intravenous |
| Subject | NEGALSTOBART | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | NEGALSTOBART | Monoclonal antibody | 1.5 mg/kg | Intravenous |
| Subject | NEGALSTOBART | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | NEGALSTOBART | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | NEGALSTOBART | Monoclonal antibody | 8 mg/kg | Intravenous |
| Subject | NEGALSTOBART | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | NEGALSTOBART | Monoclonal antibody | 20 mg/kg | Intravenous |
| Subject | NEGALSTOBART | Monoclonal antibody | 200 mg | Intravenous |
| Background | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |