drugset / Trial / NCT05274048
Neratinib and Fam-Trastuzumab Deruxtecan in Advanced Gastro-esophageal Cancer Patients
Phase 1
Recruiting
18 enrolled
Fox Chase Cancer Center
National Comprehensive Cancer Network · collabPuma Biotechnology, Inc. · collab
NaSequentialOpen-labelTreatment
Summary
This is Phase 1 dose finding trial with potential dose expansion to evaluate the safety, toxicity, recommended phase 2 dose (RP2D), and maximum tolerated dose (MTD) of Neratinib plus TDxD using a standard 3+3 dose escalation design in patients with metastatic or unresectable gastro-esophageal cancer that are HER2-overexpressing (IHC 3+ or IHC2+/ISH+) and any other gastrointestinal cancer with HER2 expression with IHC3+. Patients must have progressed or been intolerant of at least one prior line of chemotherapy + HER2 directed therapy.
Timeline
- Start
- 2022-06-24
- Primary completion
- 2026-06
- Completion
- 2027-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Neratinib | Small molecule | 120 mg | Oral |
| Subject | Neratinib | Small molecule | 160 mg | Oral |
| Subject | Neratinib | Small molecule | 200 mg | Oral |
| Subject | Trastuzumab deruxtecan | Monoclonal antibody | 5.4 mg/m2 | Intravenous |