drugset / Trial / NCT06636435
A Phase I, First in Human Study of CBA-1205, Anti-DLK1 Monoclonal Antibody in Patients With Advanced Solid Tumors, Hepatocellular Carcinoma (HCC), Melanoma, and Pediatric Cancer
Non-randomizedSequentialSingle-blindTreatment
Summary
In this first-in-human, muticenter, non-randomized, open-label, standard 3+3 dose escalation Phase I study encompasses 5 parts (Part 1-5). The purpose of this FIH study is to evaluate the safety and tolerability profile of CBA-1205.
Timeline
- Start
- 2020-06-01
- Primary completion
- 2027-06-30
- Completion
- 2027-06-30
Publications
- Background Nakamura K, Takahashi K, Sakaguchi I, Satoh T, Zhang L, Yanai H, Tsukumo Y. A Novel Glycoengineered Humanized Antibody Targeting DLK1 Exhibits Potent Anti-Tumor Activity in DLK1-Expressing Liver Cancer Cell Xenograft Models. Int J Mol Sci. 2024 Dec 19;25(24):13627. doi: 10.3390/ijms252413627.
- Results Katsuya Y, Ikeda M, Koyama T, Sato J, Okada M, Matsubara N, Kondoh C, Mukohara T, Watanabe K, Kotani D, Ogawa Y, Taoka S, Yamamoto N. A Phase I, First-In-Human Study of CBA-1205, an Anti-DLK1 Monoclonal Antibody, in Patients With Advanced Solid Tumors. Cancer Sci. 2025 Apr;116(4):1012-1022. doi: 10.1111/cas.16454. Epub 2025 Jan 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CBA-1205 | Monoclonal antibody | 0.1 mg/kg | Intravenous |
| Subject | CBA-1205 | Monoclonal antibody | 0.3 mg/kg | Intravenous |
| Subject | CBA-1205 | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | CBA-1205 | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | CBA-1205 | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | CBA-1205 | Monoclonal antibody | 20 mg/kg | Intravenous |
| Subject | CBA-1205 | Monoclonal antibody | 30 mg/kg | Intravenous |