drugset / Trial / NCT05539118
Interferon-α1b Combined With Toripalimab and Anlotinib Hydrochloride in Advanced Unresectable Melanoma
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of recombinant human interferon-α1b (IFN-α1b) combined with toripalimab and anlotinib hydrochloride in patients with unresectable advanced melanoma. This study consists of 2 phases（ Ib / II）. Phase Ib will determine the recommended phase Ⅱ dose for anlotinib hydrochloride. Phase II will evaluate the efficacy and safety of the triple combination regimens.
Timeline
- Start
- 2022-09-30
- Primary completion
- 2024-12-31
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Catequentinib | Small molecule | 8 mg | Oral |
| Subject | Catequentinib | Small molecule | 10 mg | Oral |
| Subject | Catequentinib | Small molecule | 12 mg | Oral |
| Subject | Recombinant Human Interferon α1b | Protein / enzyme biologic | 600 ug | — |
| Subject | Toripalimab | Monoclonal antibody | 240 mg | Intravenous |