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A Safety Study of SGN-LIV1A in Breast Cancer Patients

NCT01969643 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2023-03-07

No results posted yet for this study

Summary

This study will examine the safety and tolerability of ladiratuzumab vedotin (LV) in patients with metastatic breast cancer. LV will be given alone or in combination with trastuzumab.

Conditions

  • HER2 Positive Breast Neoplasms
  • Hormone Receptor Positive Breast Neoplasms
  • Triple Negative Breast Neoplasms
  • HER2 Mutations Breast Neoplasms

Interventions

DRUG

ladiratuzumab vedotin

LV will be given into the vein (IV; intravenously)

DRUG

Trastuzumab

Trastuzumab will be given by IV every 3 weeks at a dose of 6 mg/kg (the first dose will be 8 mg/kg)

Sponsors & Collaborators

  • Seagen Inc.

    lead INDUSTRY

Principal Investigators

  • Brandon Croft, PharmD · Seagen Inc.

  • Zejing Wang, MD, PhD · Seagen Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-22
Primary Completion
2023-02-04
Completion
2023-02-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01969643 on ClinicalTrials.gov