drugset / Trial / NCT06134531
First-In-Human Study of Bispecific Antibody MR001 In Subjects With Advanced Solid Tumors
NaSingle-groupOpen-labelTreatment
Summary
Phase 1 open-label study to evaluate the safety, tolerability and preliminary efficacy of bispecific antibody MR001 and to determine the maximal tolerated dose and designate the recommended phase 2 dose in subjects with locally advanced or metastatic solid cancers.
Timeline
- Start
- 2023-11
- Primary completion
- 2026-07
- Completion
- 2026-10
Publications
- Results Li S, Liu M, Do MH, Chou C, Stamatiades EG, Nixon BG, Shi W, Zhang X, Li P, Gao S, Capistrano KJ, Xu H, Cheung NV, Li MO. Cancer immunotherapy via targeted TGF-beta signalling blockade in TH cells. Nature. 2020 Nov;587(7832):121-125. doi: 10.1038/s41586-020-2850-3. Epub 2020 Oct 21.
- Results Liu M, Kuo F, Capistrano KJ, Kang D, Nixon BG, Shi W, Chou C, Do MH, Stamatiades EG, Gao S, Li S, Chen Y, Hsieh JJ, Hakimi AA, Taniuchi I, Chan TA, Li MO. TGF-beta suppresses type 2 immunity to cancer. Nature. 2020 Nov;587(7832):115-120. doi: 10.1038/s41586-020-2836-1. Epub 2020 Oct 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MR001 | Unknown | 0.5 mg/kg | Intravenous |
| Subject | MR001 | Unknown | 2 mg/kg | Intravenous |
| Subject | MR001 | Unknown | 6 mg/kg | Intravenous |
| Subject | MR001 | Unknown | 10 mg/kg | Intravenous |
| Subject | MR001 | Unknown | 15 mg/kg | Intravenous |
| Subject | MR001 | Unknown | 20 mg/kg | Intravenous |