Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05274048 | Neratinib and Fam-Trastuzumab Deruxtecan in Advanced Gastro-esophageal Cancer Patients | PHASE1 | RECRUITING | 18 | — | — | Jun 24, 2022 | Jun 1, 2027 | Oct 29, 2025 | 3 | United States |
The rate of dose-limiting toxicities (DLTs) for Neratinib + TDxD during DLT period of 28 days, in patients with advanced gastrointestinal cancer
| Arm | Type | Description |
|---|---|---|
| Neratinib plus TDxD | EXPERIMENTAL | Neratinib oral daily days 1-21 plus TDxD on day 1 administered intravenously of a 21 day treatment cycle. |
| Name | Type | Description |
|---|---|---|
| Neratinib Pill | DRUG | Patients will be enrolled in cohorts of 3 at each dose level of Neratinib (120 mg, 160 mg, 200 mg) daily (days 1 through 21) |
| Fam-Trastuzumab Deruxtecan-Nxki (TDxD) | DRUG | standard dosing of TDxD (5.4mg/m2) on day 1of a 21 day treatment cycle |
Inclusion Criteria: 1. Patients must have been diagnosed with histologically or cytologically confirmed gastrointestinal cancer (esophagus, stomach, colon, biliary, pancreas or unknown primary likely GI), and been deemed unresectable or have at least one site of metastatic disease 2. Patients must ...