Trials / Completed
CompletedNCT03281824
Clinical Study of ALT-P7 to Determine Safety, Tolerability and Pharmacokinetics in Breast Cancer Patients
Open-Label, Dose Increase and Phase I Study of ALT-P7 to Determine Safety, Tolerability, Pharmacokinetics for HER2 Positive Metastatic Breast Cancer Patients Who Have Progressed on Previous Trastuzumab-Based Therapy
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- Alteogen, Inc. · Industry
- Sex
- Female
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ALT-P7 (HM2-MMAE) | Antibody-Drug Conjugate |
Timeline
- Start date
- 2018-01-11
- Primary completion
- 2020-03-12
- Completion
- 2021-01-15
- First posted
- 2017-09-13
- Last updated
- 2022-01-18
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03281824. Inclusion in this directory is not an endorsement.