drugset / Trial / NCT03983395
Study of ISB 1302 (CD3 Bispecific Ab) in HER2-positive Metastatic Breast Cancer
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the safety profile, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of single agent ISB1302 in subjects with HER2-positive metastatic breast cancer who have been treated with all known therapies known to confer clinical benefit.
Timeline
- Start
- 2020-04-08
- Primary completion
- 2020-07-24
- Completion
- 2020-07-24
Outcome
Outcome not reported
Stopped (Business): “The study was terminated during Part 1 (dose escalation), and Part 2 (expansion) of the study was not initiated. This study was voluntarily terminated due to a business decision not to proceed with the ISB 1302 asset, and not due to any safety issue.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ISB 1302 | Unknown | 250 ng | Intravenous |
| Subject | ISB 1302 | Unknown | 325 ng | Intravenous |
| Subject | ISB 1302 | Unknown | 425 ng | Intravenous |
| Subject | ISB 1302 | Unknown | 550 ng | Intravenous |
| Subject | ISB 1302 | Unknown | 700 ng | Intravenous |
| Subject | ISB 1302 | Unknown | 900 ng | Intravenous |
| Subject | ISB 1302 | Unknown | 1200 ng | Intravenous |