drugset / Trial / NCT03281824
Clinical Study of ALT-P7 to Determine Safety, Tolerability and Pharmacokinetics in Breast Cancer Patients
NaSingle-groupOpen-labelOther
Summary
This open-label study assessed the safety, tolerability and pharmacokinetics of ALT-P7(HM2-Drug Conjugate) in patients with HER2-positive metastatic breast cancer who have progressed on previous Trastuzumab-based therapy. Patients received ALT-P7(0.3 mg/kg\~5.4 mg/kg, 7 groups) intravenously on Day 1 of each 3-week cycle.
Timeline
- Start
- 2018-01-11
- Primary completion
- 2020-03-12
- Completion
- 2021-01-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ALT-P7 | Other / unclassified | 0.3 mg/kg | Intravenous |
| Subject | ALT-P7 | Other / unclassified | 0.6 mg/kg | Intravenous |
| Subject | ALT-P7 | Other / unclassified | 1.2 mg/kg | Intravenous |
| Subject | ALT-P7 | Other / unclassified | 2.4 mg/kg | Intravenous |
| Subject | ALT-P7 | Other / unclassified | 3.6 mg/kg | Intravenous |
| Subject | ALT-P7 | Other / unclassified | 4.2 mg/kg | Intravenous |
| Subject | ALT-P7 | Other / unclassified | 4.5 mg/kg | Intravenous |
| Subject | ALT-P7 | Other / unclassified | 4.8 mg/kg | Intravenous |
| Subject | ALT-P7 | Other / unclassified | 5.4 mg/kg | Intravenous |