drugset / Trial / NCT03475251
A Study of CS1003 in Subjects With Advanced Solid Tumors
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment effect of a new drug known as CS1003 in patients with advanced tumors.
Timeline
- Start
- 2018-05-09
- Primary completion
- 2021-05-31
- Completion
- 2021-05-31
Publications
- Gong J, Guo Y, Zhang Y, Ba Y, Chen T, Li W, Zhou C, Wang M, Yang H, Zhou Y, Cai Q, Wang Z, Huang G, Zhang W, Su R, Cai Z, Yue Z, Dou J, Li P, Wu R, Tse AN, Shen L. A Phase 1a/1b Dose Escalation/Expansion Study of the Anti-PD-1 Monoclonal Antibody Nofazinlimab in Chinese Patients with Solid Tumors or Lymphoma. Target Oncol. 2024 Sep;19(5):723-733. doi: 10.1007/s11523-024-01091-8. Epub 2024 Sep 4.
- Day D, Park JJ, Coward J, Markman B, Lemech C, Kuo JC, Prawira A, Brown MP, Bishnoi S, Kotasek D, Strother RM, Cosman R, Su R, Ma Y, Yue Z, Hu HH, Wu R, Li P, Tse AN. A first-in-human phase 1 study of nofazinlimab, an anti-PD-1 antibody, in advanced solid tumors and in combination with regorafenib in metastatic colorectal cancer. Br J Cancer. 2023 Nov;129(10):1608-1618. doi: 10.1038/s41416-023-02431-7. Epub 2023 Sep 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CS1003 | Monoclonal antibody | 200 mg | Intravenous |
| Subject | CS1003 | Monoclonal antibody | 300 mg | Intravenous |
| Subject | CS1003 | Monoclonal antibody | 400 mg | Intravenous |
| Subject | Regorafenib | Small molecule | 80 mg | Oral |
| Subject | Regorafenib | Small molecule | 120 mg | Oral |