MedTrace Logo

Clinical Study of ALT-P7 to Determine Safety, Tolerability and Pharmacokinetics in Breast Cancer Patients

NCT03281824 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2022-01-18

No results posted yet for this study

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

BIOLOGICAL

ALT-P7 (HM2-MMAE)

Antibody-Drug Conjugate

Sponsors & Collaborators

  • Alteogen, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-11
Primary Completion
2020-03-12
Completion
2021-01-15

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03281824 on ClinicalTrials.gov