drugset / Trial / NCT04929080
The Safety and Efficacy of Multiple-dose of JS004 in Subject With HNC
Non-randomizedSingle-groupOpen-labelTreatment
Summary
A phase I/II clinical study of JS004 in subjects with head and neck cancer in China, to evaluate the safety, tolerability, PK, immunogenicity, antitumor activity and biomarkers of JS004, define the RP2D. A cycle is 21 days (3 weeks) which includes JS004 being administered IV Q3W and JS004 combine with JS001 being administered IV Q3W. All patients will be treated until disease progression per RECIST v1.1 and iRECIST, or intolerable toxicity per CTCAE 5.0, withdrawal of consent, or end of the study, whichever occurs first.Disease progression must be confirmed at least 4 weeks but no longer than 8 weeks after initial documentation of progression.
Timeline
- Start
- 2021-05-11
- Primary completion
- 2023-03-06
- Completion
- 2023-03-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tifcemalimab | Monoclonal antibody | 100 mg | Intravenous |
| Subject | Tifcemalimab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Tifcemalimab | Monoclonal antibody | 600 mg | Intravenous |
| Subject | Toripalimab | Monoclonal antibody | 240 mg | Intravenous |