drugset / Trial / NCT06109467
Neratinib In Combination With Chemotherapy/Trastuzumab/Pembrolizumab In HER2 Gastroesophageal Cancer
Phase 2
Active not recruiting
8 enrolled
H. Lee Moffitt Cancer Center and Research Institute
National Comprehensive Cancer Network · collabPuma Biotechnology, Inc. · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of the study is to test the effects, both good and bad, of the research study drug Neratinib in combination with Trastuzumab, Pembrolizumab and FOLFOX chemotherapy. This study will also look at the safety of Neratinib in combination with Trastuzumab, Pembrolizumab and FOLFOX in HER2 overexpressing Gastroesophageal cancers.
Timeline
- Start
- 2024-01-12
- Primary completion
- 2028-03
- Completion
- 2028-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Neratinib | Small molecule | 240 mg | Oral |
| Background | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Background | Oxaliplatin | Small molecule | 85 mg | Intravenous |
| Background | Pembrolizumab | Monoclonal antibody | 400 mg | Intravenous |
| Background | Trastuzumab | Monoclonal antibody | 4 mg/kg | Intravenous |
| Background | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |