RecruitingPhase 1Phase 2NCT06966453

A Study of Disitamab Vedotin in Adults With HER2 Expressing Advanced Breast Cancer

A PHASE 1b/2, OPEN-LABEL, MULTICOHORT STUDY OF DISITAMAB VEDOTIN IN ADULTS WITH HER2 EXPRESSING ADVANCED BREAST CANCER

Sponsor

Pfizer

Enrollment

100 participants

Start Date

Jun 30, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Breast Neoplasms

Summary

The purpose of this clinical study is to learn about the safety and effects of the study medicine (called disitamab vedotin) for the possible treatment of people with breast cancer that is hard to treat and has spread in the body (advanced cancer). This study is seeking participants who: * have breast cancer that is hard to treat and has spread in the body (advanced cancer) * have tumors that have HER2 on them * have received previous treatment for their advanced breast cancer All participants in this study will receive disitamab vedotin at the study clinic once every 2 weeks as an intravenous (IV) infusion (given directly into a vein). Participants will take the study medicine until they or their doctor decides to stop. This might be because their cancer is getting worse, the study medicine is no longer helping, they have bad side effects, or they wish to stop taking the study medicine. During this time, the participants will have study visits every 2 weeks. After the participants have stopped taking the study medicine, they will have follow-up visits about every 6 weeks unless their cancer gets worse. After that, they will have follow-up phone calls about every 12 weeks. The study team will look at the experiences of people receiving the study medicine. This will help the study team decide if the study medicine is safe and effective.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing disitamab vedotin — an antibody-drug combination that targets HER2, a protein found on some cancer cells — in adults with locally advanced or metastatic breast cancer that expresses HER2 at various levels (including lower levels than previously targeted). **You may be eligible if...** - You have confirmed locally advanced, unresectable, or metastatic breast cancer - Your tumor expresses HER2 (at any level — high, low, or ultralow) based on standard testing - Your hormone receptor status matches the cohort you are enrolling in **You may NOT be eligible if...** - You have had too many prior lines of treatment in certain cohorts - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding - You have uncontrolled brain metastases Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDisitamab vedotin

Given into the vein (IV; intravenous) every 2 weeks.

Locations(166)

Southern Cancer Center, PC

Daphne, Alabama, United States

Southern Cancer Center, PC

Foley, Alabama, United States

Southern Cancer Center, PC

Mobile, Alabama, United States

Banner Gateway Medical Center

Gilbert, Arizona, United States

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Los Angeles Cancer Network - Anaheim

Anaheim, California, United States

City of Hope National Medical Center

Duarte, California, United States

Los Angeles Cancer Network

Fountain Valley, California, United States

Los Angeles Hematology Oncology Medical Group

Glendale, California, United States

City of Hope at Irvine Lennar

Irvine, California, United States

Los Angeles Cancer Network

Los Angeles, California, United States

Valkyrie Clinical Trials

Los Angeles, California, United States

Mission Community Hospital (Satellite Site)

Los Angeles, California, United States

Clinical and Translational Research Unit (CTRU)

Palo Alto, California, United States

Stanford Cancer Center

Palo Alto, California, United States

Stanford Women's Cancer Center

Palo Alto, California, United States

Stanford Health Care, Investigational Drug Service

Stanford, California, United States

Los Angeles Hematology Oncology Medical Group

Van Nuys, California, United States