drugset / Trial / NCT04477772
A Phase I Clinical Study of JS004 in Subjects With Recurrent/Refractory Malignant Lymphoma of China
Non-randomizedSequentialOpen-labelTreatment
Summary
A First-in-human, dose-escalation, dose-expansion phase I clinical study of JS004 in subjects with recurrent/refractory malignant lymphoma in China, to evaluate the safety, tolerbility, PK, immunogenicity,antitumor activity and biomarkers of JS004, to define MTD and RP2D of JS004. 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 Lugano response critieria 2014 for Lymphoma 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
- 2020-07-17
- Primary completion
- 2024-03-14
- Completion
- 2024-03-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tifcemalimab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Tifcemalimab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Tifcemalimab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Tifcemalimab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Tifcemalimab | Monoclonal antibody | 240 mg | Intravenous |
| Subject | Toripalimab | Monoclonal antibody | 100 mg | Intravenous |
| Subject | Toripalimab | Monoclonal antibody | 200 mg | Intravenous |