drugset / Trial / NCT03251313
PD-1(Programmed Death-1) Antibody +GP as First Line Treatment for Triple Negative Breast Cancer(TNBC) Patients
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase I dose escalation trial to assess dose-limiting toxicity (DLT) and MTD of JS001+GP in advanced/metastatic TNBC patients, and to determine the recommended Phase II dose and the best combination regimen.
Timeline
- Start
- 2019-05-15
- Primary completion
- 2022-12-30
- Completion
- 2022-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Toripalimab | Monoclonal antibody | 120 mg | — |
| Subject | Toripalimab | Monoclonal antibody | 240 mg | — |
| Subject | Toripalimab | Monoclonal antibody | 480 mg | — |
| Background | Cisplatin | Other / unclassified | 75 mg/m2 | — |
| Background | Gem | Unknown | 1000 mg/m2 | — |