drugset / Trial / NCT02937116
First in Human Study of IBI308 in Chinese Subjects With Advanced Solid Tumors
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the safety, tolerability and efficacy of IBI308 monotherapy or in combination with chemotherapy in patients with certain types of advanced solid tumors. Another purpose is to determine the pharmacokinetics, pharmacodynamics and immunogenicity of IBI308.
Timeline
- Start
- 2016-10-19
- Primary completion
- 2020-09-30
- Completion
- 2020-09-30
Publications
- Results Jiang H, Zheng Y, Qian J, Mao C, Xu X, Li N, Xiao C, Wang H, Teng L, Zhou H, Wang S, Zhu D, Peng B, Shen L, Xu N. Safety and efficacy of sintilimab combined with oxaliplatin/capecitabine as first-line treatment in patients with locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma in a phase Ib clinical trial. BMC Cancer. 2020 Aug 14;20(1):760. doi: 10.1186/s12885-020-07251-z.
- Results Jiang H, Zheng Y, Qian J, Mao C, Xu X, Li N, Xiao C, Wang H, Teng L, Zhou H, Wang S, Zhu D, Sun T, Yu Y, Guo W, Xu N. Efficacy and safety of sintilimab in combination with chemotherapy in previously untreated advanced or metastatic nonsquamous or squamous NSCLC: two cohorts of an open-label, phase 1b study. Cancer Immunol Immunother. 2021 Mar;70(3):857-868. doi: 10.1007/s00262-020-02738-x. Epub 2020 Oct 17.
- Wei J, Lu X, Liu Q, Fu Y, Liu S, Li L, Liu F, Fan X, Yang J, Yang Y, Zhao Y, Guan W, Liu B. Efficacy and Safety of Sintilimab in Combination with Concurrent Chemoradiotherapy for Locally Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (SHARED): Study Protocol of a Prospective, Multi-Center, Single-Arm Phase 2 Trial. Cancer Manag Res. 2022 Jun 17;14:2007-2015. doi: 10.2147/CMAR.S355687. eCollection 2022.
- Jia R, Li Y, Xu N, Jiang HP, Zhao CH, Liu RR, Shi Y, Zhang YY, Wang SY, Zhou H, Xu JM. Sintilimab in Patients with Previously Treated Metastatic Neuroendocrine Neoplasms. Oncologist. 2022 Aug 5;27(8):e625-e632. doi: 10.1093/oncolo/oyac097.
- Jiang H, Li N, Wang H, Chen Z, Zheng Y, Qian J, Mao C, Xu X, Xiao C, Zhang X, Zhou H, Wang S, Chen W, Yin X, Sun J, Peng B, Teng L, Xu N. Assessment of TMB, PD-L1, and lymphocyte to monocyte ratio as predictive potential in a phase Ib study of sintilimab in patients with advanced solid tumors. Am J Cancer Res. 2021 Sep 15;11(9):4259-4276. eCollection 2021.
- Zhang J, Wu L, Liu J, Lin M. A metastatic intrahepatic cholangiocarcinoma treated with programmed cell death 1 inhibitor: a case report and literature review. Immunotherapy. 2020 Jun;12(8):555-561. doi: 10.2217/imt-2019-0100. Epub 2020 May 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Subject | Etoposide | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 1250 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 125 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 130 mg/m2 | — |
| Subject | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |
| Subject | Sintilimab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Sintilimab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Sintilimab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | fluorouracil | Small molecule | 1000 mg/m2 | Intravenous |
Indications
No indication recorded.