drugset / Trial / NCT04727164
Study Investigating Safety,Tolerability,Pharmacokinetics and Antitumor Activities of HBM4003 Combine With Toripalimab
NaSingle-groupOpen-labelTreatment
Summary
HBM4003 in combination with Toripalimab. The expected duration of treatment for each subject will vary according to the number of cycles completed; the number of cycles will depend on whether the subject benefits from the treatment. The study consists of a 4-week screening period, a 21-day treatment cycle (repeatable, depending on the presence/absence of clinical benefit), EOT visit after discontinuation of treatment, and 2 follow-up visits 28 days (± 2 days) and 84 days (± 5 days) after the last study medication.
Timeline
- Start
- 2021-02-28
- Primary completion
- 2023-11
- Completion
- 2023-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PORUSTOBART | Monoclonal antibody | 0.03 mg/kg | — |
| Subject | PORUSTOBART | Monoclonal antibody | 0.1 mg/kg | — |
| Subject | PORUSTOBART | Monoclonal antibody | 0.3 mg/kg | — |
| Subject | Toripalimab | Monoclonal antibody | 240 mg | — |