drugset / Trial / NCT03469557
BGB A317 in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Esophageal, Gastric, or Gastroesophageal Junction Carcinoma
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase 2, multi-cohort study to investigate safety, PK, and preliminary anti-tumor activity of the monoclonal antibody BGB A317 in combination with standard chemotherapy as first-line treatment. Cohorts include an ESCC cohort and a gastric carcinoma (GC) or GEJ carcinoma cohort that will be enrolled concurrently. The study includes a screening (up to 28 days), treatment (until disease progression, intolerable toxicity, or treatment withdrawal for another reason), safety follow-up (up to 30 days following last study drug treatment), and survival follow-up phase.
Timeline
- Start
- 2017-07-18
- Primary completion
- 2019-03-31
- Completion
- 2020-08-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | Cisplatin | Other / unclassified | 80 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |
| Subject | Tislelizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | fluorouracil | Small molecule | 800 mg/m2 | Intravenous |