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Experimental drug duo targets Hard-to-Treat HER2 cancers

NCT ID NCT06157892

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 23, 2026 · Updated 4 times

Summary

This study tests two drugs together—disitamab vedotin and tucatinib—in people with advanced breast or stomach cancers that have a protein called HER2. The goal is to see if the combination is safe and shrinks tumors. About 172 participants will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
disitamab vedotin and tucatinib
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced HER2-positive breast or stomach cancers that have stopped responding to standard therapies.
What could go wrong
This is an early-phase trial (phase 1b/2) with a small number of participants, so the combination may prove unsafe or ineffective. Side effects from both drugs could be significant.

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

54 people

The number who actually took part.

Started

May 2024

Expected to finish

Jul 2029

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: General Inclusion Criteria * Measurable disease according to RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 Dose Escalation and Optimization Phase Inclusion Criteria * Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma or breast carcinoma * Locally-advanced, unresectable, or metastatic stage * Must have experienced disease progression on or after standard of care therapies or be intolerant of standard of care therapies. Cohort A (HER2-Low Breast Cancer) Inclusion Criteria * Histologically or cytologically confirmed diagnosis of breast carcinoma * Locally-advanced, unresectable, or metastatic stage * HER2-low status determined by most recent local assessment (IHC 1+ or IHC 2+/ISH-negative) * Prior therapies requirements * No more than 3 prior systemic cytotoxic chemotherapy regimens (including ADCs) for LA/mBC. * Participants with known BRCA mutation must have received a PARP-inhibitor where available and not medically contraindicated * Have progression on or after, or intolerant to, T-DXd, sacituzumab govitecan, or other topoisomerase I inhibitor therapies, if available as local standard of care therapy * Participants with HR+ tumors must have intolerance to endocrine therapy or endocrine therapy refractory disease: * Progressed on ≥2 lines of endocrine therapy for LA/mBC AND had received a CDK4/6 inhibitor in the adjuvant or metastatic setting OR * Progressed on 1 line of endocrine therapy for LA/mBC AND had a relapse while on adjuvant endocrine therapy after definitive surgery for primary tumor AND had received a CDK4/6 inhibitor in the adjuvant or advanced setting * Participants with HR negative, HER2-low and PD-L1-positive (CPS 10 or greater) tumors must have received pembrolizumab with chemotherapy if available as local standard of care therapy. * Participants with HR negative, HER2-low and PD-L1-positive (CPS 10 or greater) tumors must have received pembrolizumab (or other PD-(L)1 inhibitor) with chemotherapy if available as local standard of care therapy and not medically contraindicated. Cohort B (HER2+ Breast Cancer) Inclusion Criteria * Histologically or cytologically confirmed diagnosis breast carcinoma * Locally-advanced, unresectable, or metastatic stage * HER2+ status determined by most recent local assessment (IHC 3+ or IHC 2+/ISH+) * Participants must have: * Received prior trastuzumab, pertuzumab and a taxane if available as local standard of care therapy for advanced disease. * Have progression on or after, or intolerant to, T-DXd or other topoisomerase I inhibitor therapies * No more than 3 prior systemic cytotoxic chemotherapy regimens (including ADCs) for LA/mBC Cohort C (HER2-Low Gastric or Gastroesophageal Junction Adenocarcinoma) Inclusion Criteria * Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma * Locally-advanced, unresectable, or metastatic stage * HER2-low expression defined as IHC 1+ or IHC 2+/ISH-negative determined by most recent local assessment * Willing and able to provide archival or newly obtained formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks * Participants must have received: * Prior systemic therapy with platinum, fluorouracil, or taxane for locally advanced unresectable or metastatic disease * Progression within 6 months of last dose of (neo)adjuvant cytotoxic chemotherapy is considered as 1 line of systemic therapy for LA/mGC/GEJC * Prior anti-PD-(L)1 therapy is allowed * No more than 2 prior systemic cytotoxic chemotherapy regimens (including ADC) for LA/mGC/GEJC * Must not have received prior treatment with HER2 directed therapy Cohort D (HER2+ LA/mGC/GEJC) Inclusion Criteria * Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma * Locally-advanced, unresectable, or metastatic stage * HER2+ status determined by most recent local assessment (IHC 3+ or IHC 2+/ISH+) * Participants must have: * Received prior trastuzumab plus fluoropyrimidine and platinum containing chemotherapy if no contraindication. * Prior T-DXd treatment is allowed * Prior PD1 inhibitor therapy is allowed * No more than 2 prior systemic cytotoxic chemotherapy regimens (including ADCs) for LA/mGC/GEJC Exclusion Criteria: * Known hypersensitivity to any excipient contained in the drug formulation of disitamab vedotin or tucatinib * Prior therapy with ADCs with MMAE payload * Prior therapy with tucatinib * Active CNS and/or leptomeningeal metastasis. * Participants who have received prior systemic anticancer treatment including investigational agents within 4 weeks prior to first dose of study treatment * History of other invasive malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy. * Unable to swallow oral tablets or capsules or any significant GI disease which would preclude the adequate oral absorption of medications

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm gastric adenocarcinoma gastric cancer gastric neoplasm gastroesophageal junction adenocarcinoma HER2 positive breast carcinoma triple-negative breast carcinoma

As listed by the trial registrant

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

Advanced breast cancer Advanced gastric cancer Breast neoplasms Gastroesophageal junction adenocarcinoma HER2 low breast neoplasms HER2 positive breast neoplasms Metastatic breast cancer Metastatic gastric cancer Stomach neoplasms Triple negative breast neoplasms

Contacts and locations

Locations

  • A.O.U. Federico II

    Naples, Campania, 80131, Italy

  • A.O.U. Federico II- U.O.C. Diagnostica per lmmagini e Radioterapia

    Naples, 80131, Italy

  • Atlanta Cancer Care - Atlanta

    Atlanta, Georgia, 30342, United States

  • Atlanta Cancer Care - Cumming

    Cumming, Georgia, 30041, United States

  • Azienda Ospedaliera Universitaria (AOU) Federico II

    Naples, Campania, 80131, Italy

  • Azienda Ospedaliera Universitaria Integrata di Verona.

    Verona, Veneto, 37134, Italy

  • BC Cancer Kelowna.

    Kelowna, British Columbia, V1Y 5L3, Canada

  • Banner-University Medical Center Tucson Campus

    Tucson, Arizona, 85704, United States

  • Banner-University Medical Center Tucson Campus

    Tucson, Arizona, 85719, United States

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Cancer Institute Hospital of JFCR

    Koto-ku, Tokyo, 135-8550, Japan

  • Carbone Cancer Center / University of Wisconsin

    Madison, Wisconsin, 53792, United States

  • Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital

    Taoyuan, 333, Taiwan

  • Charité Universitätsmedizin Berlin, Campus Benjamin Franklin (CBF)

    Berlin, 12203, Germany

  • Chungbuk National University Hospital

    Cheongju-si, 28644, South Korea

  • Colorado West Healthcare System, dba Community Hospital

    Grand Junction, Colorado, 81505, United States

  • Colorado West Healthcare, dba Grand Valley Oncology

    Grand Junction, Colorado, 81505, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Dana Farber Cancer Institute- Chestnut Hill

    Newton, Massachusetts, 02459, United States

  • Dong-A University Hospital

    Busan, Other, 49201, South Korea

  • Ecg Medica Sl

    Valencia, 46004, Spain

  • Farmacia-Ensayos. Planta S - Hospital Universitario HM Sanchinarro-CIOCC-START Madrid

    Madrid, 28050, Spain

  • Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington

    Seattle, Washington, 98109, United States

  • Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007, United States

  • Georgia Cancer Specialists - Annex

    Atlanta, Georgia, 30341, United States

  • Georgia Cancer Specialists - Athens

    Athens, Georgia, 30606, United States

  • Georgia Cancer Specialists - Blairsville

    Blairsville, Georgia, 30512, United States

  • Georgia Cancer Specialists - Canton

    Canton, Georgia, 30115, United States

  • Georgia Cancer Specialists - Cumming

    Cumming, Georgia, 30041, United States

  • Georgia Cancer Specialists - Decatur

    Decatur, Georgia, 30033, United States

  • Georgia Cancer Specialists - Macon

    Macon, Georgia, 31217, United States

  • Georgia Cancer Specialists - Marietta

    Marietta, Georgia, 30060, United States

  • Georgia Cancer Specialists-Northside

    Atlanta, Georgia, 30342, United States

  • Grupo Hospitalario QuironSalud

    Erandio Bizkaia, 48950, Spain

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612, United States

  • Harborview Medical Center

    Seattle, Washington, 98104, United States

  • Heidelberg University Hospital and German Cancer Research Center

    Heidelberg, 69120, Germany

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Universitari Vall d´Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario de Basurto

    Bilbao, 48013, Spain

  • Humanitas Istituto Clinico Catanese

    Misterbianco (CT), Sicily, 95045, Italy

  • Institut Catala d'Oncologia

    Barcelona, 08908, Spain

  • Investigational Drug Service

    Long Island City, New York, 11101, United States

  • Istituto Europeo di Oncologia

    Milan, Lombardy, 20141, Italy

  • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale.

    Naples, Campania, 80131, Italy

  • Japanese Foundation for Cancer Research

    Koto-ku, Tokyo, 135-8550, Japan

  • Korea University Anam Hospital

    Seoul, 02841, South Korea

  • Linkou Chang Gung Memorial Hospital

    Taoyuan City, 333, Taiwan

  • MSK Basking Ridge

    Basking Ridge, New Jersey, 07920, United States

  • MSK Bergen.

    Montvale, New Jersey, 07645, United States

  • MSK Commack.

    Commack, New York, 11725, United States

  • MSK Monmouth.

    Middletown, New Jersey, 07748, United States

  • MSK Nassau.

    Uniondale, New York, 11553, United States

  • MSK Westchester.

    Harrison, New York, 10604, United States

  • Massachusetts General Hospital.

    Boston, Massachusetts, 02114, United States

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007, United States

  • Memorial Hospital

    Shiloh, Illinois, 62269, United States

  • Memorial Sloan Kettering - Bergen

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering - Monmouth

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering - Westchester

    Harrison, New York, 10604, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Cancer Center - Basking Ridge

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Cancer Center - Commack

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Cancer Center - Main Hospital

    New York, New York, 10065, United States

  • Memorial Sloan Kettering- Nassau

    Uniondale, New York, 11553, United States

  • Moffitt Cancer Center - International Plaza

    Tampa, Florida, 33607, United States

  • Moffitt Cancer Center - McKinley Campus

    Tampa, Florida, 33612, United States

  • Moffitt Cancer Center at Wesley Chapel

    Wesley Chapel, Florida, 33544, United States

  • Moffitt McKinley Hospital

    Tampa, Florida, 33612, United States

  • National Cancer Center

    Goyang-si, Other, 10408, South Korea

  • National Cheng Kung University Hospital

    Tainan, 704017, Taiwan

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • National Taiwan University Cancer Center

    Taipei, 106, Taiwan

  • National Taiwan University Hospital

    Taipei, 100225, Taiwan

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • Niguarda Ca' Granda Hospital

    Milan, Lombardy, 20162, Italy

  • Northside Hospital

    Atlanta, Georgia, 30342, United States

  • Northside Hospital, Inc.- Central Research Department

    Atlanta, Georgia, 30342, United States

  • Okayama University Hospital

    Okayama, 700-8558, Japan

  • Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6, Canada

  • Peninsula & South Eastern Hematology and Oncology Group (PASO)

    Frankston, Victoria, 3199, Australia

  • Peninsula & South Eastern Hematology and Oncology Group (PASO)

    Frankston, Australia

  • Peter MacCallum Cancer Centre

    Melbourne, 3000, Australia

  • Providence Health and Services Washington and Montana

    Renton, Washington, 98057, United States

  • Quirén Salud Barcelona

    Barcelona, 08023, Spain

  • Renown Regional Medical Center

    Reno, Nevada, 89502, United States

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203, United States

  • START Madrid-CIOCC_Hospital HM Sanchinarro

    Madrid, 28050, Spain

  • Saint Francis Hospital / Bon Secours - South Carolina

    Greenville, South Carolina, 29607, United States

  • Saint Luke's Cancer Institute LLC

    Kansas City, Missouri, 64111, United States

  • Saint Luke's Hospital Investigational Pharmacy

    Kansas City, Missouri, 64111, United States

  • San Juan Oncology Associates

    Farmington, New Mexico, 87401, United States

  • Sarah Cannon Research Institute - Pharmacy

    Nashville, Tennessee, 37203, United States

  • Seoul National University Bundang Hospital

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

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [seoul], 03080, South Korea

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • Showa Medical University Hospital

    Tokyo, 142-8666, Japan

  • Showa University Hospital

    Shinagawa-ku, Tokyo-to, 142-8666, Japan

  • Siteman Cancer Center - North County

    Florissant, Missouri, 63031, United States

  • Siteman Cancer Center - Shiloh

    Shiloh, Illinois, 62269, United States

  • Siteman Cancer Center - South County

    St Louis, Missouri, 63129, United States

  • Siteman Cancer Center - St Peters

    City of Saint Peters, Missouri, 63376, United States

  • Siteman Cancer Center - West County

    Creve Coeur, Missouri, 63141, United States

  • Slade Health

    Mount Waverley, Victoria, 3149, Australia

  • Slade Pharmacy Frankston

    Frankston, Victoria, 3199, Australia

  • St Bartholomew's Hospital

    London, EC1M 6BQ, United Kingdom

  • St. Vincent's Hospital, The Catholic University of Korea

    Suwon, 16247, South Korea

  • Suburban Hematology-Oncology Associates - Duluth

    Duluth, Georgia, 30096, United States

  • Suburban Hematology-Oncology Associates- Lawrenceville

    Lawrenceville, Georgia, 30046, United States

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5, Canada

  • Tennessee Oncology-Nashville/Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • The Christie NHS Foundation Trust

    Manchester, M20 4GJ, United Kingdom

  • The Royal Marsden Hospital

    Sutton, Surrey, SM2 5PT, United Kingdom

  • The Royal Marsden Hospital

    London, SW3 6JJ, 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 Royal Marsden NHS Foundation Trust

    Sutton, SM2 5PT, United Kingdom

  • The Royal Marsden NHS Foundation Trust (RM)

    London, SW3 6JJ, United Kingdom

  • The University of Arizona Cancer Center-Main

    Tucson, Arizona, 85724, United States

  • The University of Arizona Cancer Center-North Campus Pharmacy, Attn: Kelly Myrdal

    Tucson, Arizona, 85719, United States

  • UC Irvine Health - Chao Family Comprehensive Cancer Center

    Orange, California, 92868, United States

  • UC Irvine Medical Center

    Orange, California, 92868, United States

  • UCLA Department of Medicine - Hematology & Oncology

    Santa Monica, California, 90404, United States

  • UCLA Hematology/Oncology - Parkside

    Santa Monica, California, 90404, United States

  • Universitatsklinikum Essen

    Essen, 45147, Germany

  • University Health Network - Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • University of Arizona Cancer Center - North Campus

    Tucson, Arizona, 85719, United States

  • University of California, San Francisco | HDFCCC - Hematopoietic Malignancies

    San Francisco, California, 94158, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

    Madison, Wisconsin, 53718, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Washington University School of Medicine - Siteman Cancer Center

    St Louis, Missouri, 63110, United States

  • Zangmeister Cancer Center

    Columbus, Ohio, 43219, United States

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