A Study of U3-1402 (Patritumab Deruxtecan) in Subjects With Metastatic Breast Cancer

Completed · Phase 2

Conditions studied: Metastatic Breast Cancer, Locally Advanced Breast Cancer

In brief

This study is to evaluate safety and efficacy of an antibody drug conjugate U3-1402 (patritumab deruxtecan) in patients with locally advanced or metastatic breast cancer (MBC).

Key facts

Study ID

NCT04699630

Run by

SCRI Development Innovations, LLC

People needed

121

Starts

2021-05-03

Expected to finish

2025-04-09

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients who meet any of the following criteria will be excluded from study entry:
• Exclusion criteria for Parts A and B (HER2-negative) and Part Z (HER2-positive) cohorts:
• Treatment with any of the following:
• Any systemic anti-cancer chemotherapy, small molecule, biologic, hormonal agent, or immune checkpoint inhibitor therapy from a previous treatment regimen or clinical study within 21 days prior to the first dose of patritumab deruxtecan
• Prior treatment with any HER3-targeting agent
• Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study drug treatment
• Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug treatment, or palliative radiation therapy within 2 weeks of the first dose of study drug treatment
• Chloroquine /hydroxychloroquine ≤14 days prior to the first dose of study drug treatment
• Has any hypersensitivity to drug substances or inactive ingredients in drug product
• Has any history of ILD (including pulmonary fibrosis or radiation pneumonitis), has clinically significant ILD, or is suspected to have such disease by imaging during screening. If imaging findings are unlikely to indicate a history of pneumonitis, then the Investigator should discuss the considerations with the Medical Monitor about potential enrollment and record the reasoning in the source documentation.
• Clinically severe pulmonary compromise (based on Investigator's assessment) resulting from intercurrent pulmonary illnesses including, but not limited to:
• Any underlying pulmonary disorder (e.g., pulmonary emboli, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion)
• Any autoimmune, connective tissue or inflammatory disorder with pulmonary involvement (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis)
• OR prior pneumonectomy
• With the exception of alopecia, any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or baseline at the time of starting study treatment. Note: patients with chronic Grade 2 toxicities who are asymptomatic or adequately managed with stable medication may be eligible with approval by the Medical Monitor.
• Leptomeningeal metastases or evidence of spinal cord compression or brain metastases, defined as being clinically active and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Patients with clinically inactive or treated brain metastases who are asymptomatic (i.e., without neurologic signs or symptoms and do not require treatment with corticosteroids or anticonvulsants) may be included in the study. Patients must have a stable neurologic status for at least 2 weeks prior to Cycle 1 Day 1.
• Women who are pregnant, nursing, or plan to become pregnant while in the study and for at least 7 months after the last administration of study treatment
• Men who plan to father a child while in the study and for at least 7 months after the last administration of study treatment
• Uncontrolled or significant cardiovascular disorder prior to Cycle 1 Day 1, including:
• Mean resting corrected QT interval using Fridericia's formula (QTcF) prolongation to >470 ms for females and >450 ms for males in three successive screening measurements
• Patients with a left ventricular ejection fraction (LVEF) <50%
• Resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg).
• Documented myocardial infarction within 6 months
• Congestive heart failure (New York Heart Association ≥ Grade 2 within 28 days
• Has known clinically significant corneal disease from prior therapies such as drug-induced keratitis

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Highlands Oncology Group — Springdale, Arkansas, United States
• City of Hope — Duarte, California, United States
• Florida Cancer Specialists-South — Fort Myers, Florida, United States
• Florida Cancer Specialists-North — St. Petersburg, Florida, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Rutgers-Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• SCRI Oncology Partners — Nashville, Tennessee, United States
• Tennessee Oncology — Nashville, Tennessee, United States
• Fred Hutchinson Cancer Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.