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New drug combo shows promise for Hard-to-Treat HER2 cancers

NCT ID NCT04579380

Disease control Sponsor: Seagen, a wholly owned subsidiary of Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This study tests a two-drug combination (tucatinib and trastuzumab) in people with advanced solid tumors that have HER2 alterations. The goal is to see if the treatment can shrink or control tumors. About 217 participants with various cancers (like lung, uterine, or bile duct) will receive the drugs, and some breast cancer patients will get an additional hormone therapy. The study also tracks side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

217 people

The number who actually took part.

Started

Jan 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * Histologically or cytologically confirmed diagnosis of locally-advanced unresectable or metastatic solid tumor, including primary brain tumors * Participants with non-squamous NSCLC must have progressed during or after standard treatment or for which no standard treatment is available * Participants with other disease types must have progressed during or after ≥1 prior line of systemic therapy for locally-advanced unresectable or metastatic disease * Disease progression during or after, or intolerance of, the most recent line of systemic therapy * Disease demonstrating HER2 alterations (overexpression/amplification or HER2 activating mutations), as determined by local or central testing processed in a Clinical Laboratory Improvement Amendments (CLIA)- or International Organization for Standardization (ISO) accredited laboratory, according to one of the following: * HER2 overexpression/amplification from fresh or archival tumor tissue or blood * Known activating HER2 mutations detected in fresh or archival tumor tissue or blood * Have measurable disease per RECIST v1.1 criteria according to investigator assessment * Have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Exclusion Criteria * Participants with breast cancer, gastric or gastroesophageal junction adenocarcinoma, or CRC whose disease shows HER2 amplification/overexpression. * Previous treatment with HER2-directed therapy; participants with uterine serous carcinoma or HER2-mutated gastric or gastroesophageal junction adenocarcinoma without HER2-overexpression/amplification may have received prior trastuzumab * Known hypersensitivity to any component of the drug formulation of tucatinib or trastuzumab (drug substance, excipients, murine proteins), or any component of the drug formulation of fulvestrant in participants with HR+ HER2-mutated breast cancer * History of exposure to a 360 mg/m² doxorubicin-equivalent or \>720 mg/m\^2 epirubicin-equivalent cumulative dose of anthracyclines * Treatment with any systemic anti-cancer therapy, radiation therapy, major surgery, or experimental agent within ≤3 weeks of first dose of study treatment or are currently participating in another interventional clinical trial. There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.

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Conditions

The condition(s) this trial relates to.

benign urinary system neoplasm biliary tract cancer biliary tract neoplasm Biliary Tract Neoplasms breast cancer breast neoplasm cervical cancer colorectal neoplasm neoplasm non-small cell lung carcinoma tumor of uterus urinary system neoplasm urothelial carcinoma uterine cancer Uterine Cervical Neoplasms uterine cervix neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Biliary tract neoplasms Carcinoma, non-small-cell lung HER2 mutations breast neoplasms Urologic neoplasms Uterine cervical neoplasms Uterine neoplasms

Contacts and locations

Locations

  • 1 S Park St Medical Center

    Madison, Wisconsin, 53715, United States

  • AZ Groeninge

    Kortrijk, 8500, Belgium

  • AZ Sint-Maarten

    Mechelen, 2800, Belgium

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken, 464-8681, Japan

  • Ascires Eresa Campanar

    Valencia, 46015, Spain

  • Barnes-Jewish Hospital Investigational Drug Pharmacy (IDS)

    St Louis, Missouri, 63110, United States

  • CHU de Liege

    Liège, 4000, Belgium

  • Cetir Centre Medic

    Barcelona, 08029, Spain

  • Charite Universitatsmedizin Berlin

    Berlin, 12203, Germany

  • City of Hope Torrance

    Torrance, California, 90505, United States

  • City of Hope at Huntington Beach

    Huntington Beach, California, 92648, United States

  • City of Hope at Irvine Sand Canyon

    Irvine, California, 92618, United States

  • City of Hope at Long Beach Elm

    Long Beach, California, 90813, United States

  • City of Hope at Long Beach Worsham

    Long Beach, California, 90808, United States

  • City of Hope at Newport Beach Lido

    Newport Beach, California, 92663, United States

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Diagnostic Centre

    London, Others, W1G 7AF, United Kingdom

  • Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative lstituto Europeo di Oncologia

    Milan, Milan, 20141, Italy

  • Drug Storage and Regulatory location: MMCORC

    Saint Louis Park, Minnesota, 55426, United States

  • Duke University Medical Center/Duke Cancer Center

    Durham, North Carolina, 27710, United States

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109, United States

  • Grand Hopital de Charleroi

    Charleroi, Hainaut, B- 6060, Belgium

  • Guy's Hospital

    London, SE1 9RT, United Kingdom

  • HonorHealth

    Phoenix, Arizona, 85016, United States

  • HonorHealth

    Tempe, Arizona, 85284, United States

  • Hospital Clínico Universitario de Valencia. Fundación Investigación Clínico de Valencia.

    Valencia, 46010, Spain

  • Hospital Vithas Valencia 9 de Octubre

    Valencia, 46015, Spain

  • Huntsman Cancer Institute, University of Utah

    Salt Lake City, Utah, 84112, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Institut Catala d'Oncologia Hospitalet

    L'Hospitalet de Llobregat, Other, 8908, Spain

  • Jonathan Poon

    London, SE1 9RT, United Kingdom

  • Kindai University Hospital

    Osakasayama-shi, Osaka, 589-8511, Japan

  • Koman Family Outpatient Pavilion

    La Jolla, California, 92037, United States

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016, United States

  • Metro Minnesota Community Oncology Research Consortium (MMCORC)

    Saint Louis Park, Minnesota, 55426, United States

  • Minnesota Oncology Hematology, PA

    Coon Rapids, Minnesota, 55433, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • NYU Langone Health - Long Island (Winthrop Hospital)

    Mineola, New York, 11501, United States

  • NYU Langone Medical Center

    New York, New York, 10016, United States

  • National Cancer Center Hospital

    Cho-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577, Japan

  • Northwest Cancer Specialists, P.C.

    Portland, Oregon, 97213, United States

  • Northwest Cancer Specialists, P.C.

    Portland, Oregon, 97227, United States

  • Northwest Cancer Specialists, P.C.

    Tigard, Oregon, 97223, United States

  • Northwest Cancer Specialists, P.C.

    Vancouver, Washington, 98684, United States

  • OSU Wexner Medical Center, Arther G. James Cancer Hospital, and Solove Research Institute

    Columbus, Ohio, 43210, United States

  • OSU Wexner Medical Center, CarePoint East

    Columbus, Ohio, 43203, United States

  • OSU Wexner Medical Center, CarePoint Gahanna

    Gahanna, Ohio, 43230, United States

  • OSU Wexner Medical Center, Gynecologic Oncology at Mill Run

    Hilliard, Ohio, 43026, United States

  • OSU Wexner Medical Center, Investigational Drug Services(IP Ship to)

    Columbus, Ohio, 43210, United States

  • OSU Wexner Medical Center, Martha Morehouse Medical Plaza

    Columbus, Ohio, 43221, United States

  • OSU Wexner Medical Center, Ohio State University Hospital East

    Columbus, Ohio, 43203, United States

  • OSU Wexner Medical Center, OutPatient Care Upper Arlington

    Columbus, Ohio, 43221, United States

  • OSU Wexner Medical Center, Outpatient Care Lewis Center

    Lewis Center, Ohio, 43035, United States

  • OSU Wexner Medical Center, Outpatient Care New Albany

    Westerville, Ohio, 43081, United States

  • OSU Wexner Medical Center, Stephanie Spielman Comprehensive Breast Center

    Columbus, Ohio, 43212, United States

  • Oncology Hematology West P.C. dba Nebraska Cancer Specialists

    Omaha, Nebraska, 68114, United States

  • Oncology Hematology West P.C. dba Nebraska Cancer Specialists

    Omaha, Nebraska, 68130, United States

  • Osu Wexner Medical Center, The Ohio State University Hospital

    Columbus, Ohio, 43210, United States

  • Perlmutter Cancer Center at NYU Langone GYN Oncology Associates

    Mineola, New York, 11501, United States

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island

    Mineola, New York, 11501, United States

  • Prisma Health Cancer Institute

    Boiling Springs, South Carolina, 29316, United States

  • Prisma Health Cancer Institute

    Easley, South Carolina, 29640, United States

  • Prisma Health Cancer Institute

    Greenville, South Carolina, 29605, United States

  • Prisma Health Cancer Institute

    Greenville, South Carolina, 29615, United States

  • Prisma Health Cancer Institute

    Greer, South Carolina, 29650, United States

  • Prisma Health Cancer Institute

    Seneca, South Carolina, 29672, United States

  • Radiology

    London, W1G 8PP, United Kingdom

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, 80012, United States

  • Rocky Mountain Cancer Centers

    Boulder, Colorado, 80303, United States

  • Rocky Mountain Cancer Centers

    Thornton, Colorado, 80260, United States

  • Royal Marsden NHS Foundation Trust

    Sutton, Surrey, SM2 5PT, United Kingdom

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Sarah Cannon Research Institute UK

    London, Budapest, W1G 6AD, United Kingdom

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    Seoul, Other, 03722, South Korea

  • St. Marianna University School of Medicine Hospital

    Kawasaki, Kanagawa, 216-8511, Japan

  • Tennessee Oncology, PLLC

    Gallatin, Tennessee, 37066, United States

  • Tennessee Oncology, PLLC

    Hendersonville, Tennessee, 37075, United States

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203, United States

  • Tennessee Oncology, PLLC

    Shelbyville, Tennessee, 37160, United States

  • Texas Oncology - Central South

    Waco, Texas, 76712, United States

  • Texas oncology-West Texas

    Abilene, Texas, 79606, United States

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550, Japan

  • The Harley Street Clinic

    London, W1G 8BJ, United Kingdom

  • The Royal Marsden NHS Foundation Trust

    Sutton, Surrey, SM2 5PT, United Kingdom

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ, United Kingdom

  • The University of Arizona Cancer Center-North Campus

    Tucson, Arizona, 85719, United States

  • UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)

    La Jolla, California, 92037, United States

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92037, United States

  • UC San Diego Moores Cancer Center- Investigational Drug Services

    La Jolla, California, 92037, United States

  • UH Minoff Health Center at Chagrin Highlands

    Orange, Ohio, 44122, United States

  • UPMC Hillman Cancer Center - Washington

    Washington, Pennsylvania, 15301, United States

  • US Oncology Investigational Product Center (IPC)

    Irving, Texas, 75063, United States

  • US Oncology Investigational Products Center (IPC)

    Irving, Texas, 75063, United States

  • US Oncology lnvestigational Products Center (IPC)

    Irving, Texas, 75063, United States

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650, Belgium

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

  • University of Wisconsin Clinical Science Center

    Madison, Wisconsin, 53792, United States

  • Virginia Cancer Specialists, PC

    Alexandria, Virginia, 22304, United States

  • Virginia Cancer Specialists, PC

    Arlington, Virginia, 22205, United States

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031, United States

  • Virginia Cancer Specialists, PC

    Gainesville, Virginia, 20155, United States

  • Washington University School of Medicine - Obstetrics & Gynecology

    St Louis, Missouri, 63110, United States

  • Washington University School of Medicine - Obstetrics & Gynecology [Academic Offices)

    St Louis, Missouri, 63108, United States

  • Washington University School of Medicine [Patient Clinics]

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.