drugset / Trial / NCT02512237
A Dose-escalation Study of ARX788, IV Administered in Subjects With Advanced Cancers With HER2 Expression
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a 2-part, Phase 1 FIH study with Phase 1a designed to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) in subjects with metastatic cancers with a human epidermal growth factor receptor 2 (HER2) test result that is in situ hybridization (ISH) positive (+) or immunohistochemistry (IHC) 3+ or 2+, and Phase 1b designed to assess anticancer activity and safety in three expansion cohorts: two different advanced breast cancer expansion cohorts (namely, for tumors that test as HER2 ISH positive or IHC3+ and for tumors that test as HER2 ISH negative with IHC 2+), and one advanced gastric cancer expansion cohort (for tumors that test as HER2 ISH positive or IHC3+).
Timeline
- Start
- 2016-03
- Primary completion
- 2017-01
- Completion
- 2017-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ANVATABART OPADOTIN | Other / unclassified | 0.33 mg/kg | Intravenous |
| Subject | ANVATABART OPADOTIN | Other / unclassified | 0.66 mg/kg | Intravenous |
| Subject | ANVATABART OPADOTIN | Other / unclassified | 1.3 mg/kg | Intravenous |
| Subject | ANVATABART OPADOTIN | Other / unclassified | 2.2 mg/kg | Intravenous |
| Subject | ANVATABART OPADOTIN | Other / unclassified | 2.9 mg/kg | Intravenous |
| Subject | ANVATABART OPADOTIN | Other / unclassified | 3.8 mg/kg | Intravenous |