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Experimental drug targets HER2-Positive tumors in multiple cancers

NCT ID NCT06003231

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 3 times

Summary

This phase 2 trial tests an experimental drug called disitamab vedotin in people with advanced head and neck, lung, endometrial, or ovarian cancers that have a protein called HER2. The drug is designed to stick to cancer cells and kill them. Researchers want to see if it shrinks tumors and how safe it is. About 120 participants will receive the drug every two weeks.

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 (an antibody-drug conjugate given intravenously)
What this could lead to
If it works, this could point toward a new treatment option for several types of advanced cancers that have the HER2 marker.
What could go wrong
This is an early-phase trial with only 120 participants, so results may not apply to all patients. Side effects are possible, and the drug may not shrink tumors as hoped.

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

120 people

The number who actually took part.

Started

Nov 2023

Expected to finish

May 2028

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: * Cohort 1: Head and neck cancer (HNC) * Must have pathologically-documented carcinoma of the head and neck with primary tumor site arising from the oral cavity, salivary gland, oropharynx, hypopharynx, and larynx; tumors arising from the nasopharynx are excluded. * Unresectable locally recurrent or metastatic stage disease * Prior therapies: * Participants must have disease progression after treatment with a platinum-based therapy * Cohort 2: Non-small cell lung cancer (NSCLC) * Pathologically documented NSCLC * Unresectable locally-advanced or metastatic stage disease * Prior therapies * Must have progressed during or after a platinum-based therapy for LA/metastatic disease or, within 6 months of platinum-based adjuvant, neoadjuvant, or concomitant chemoradiotherapy for early or locally-advanced stage disease * Must have received prior anti-PD(L)1 therapy, unless contraindicated * Participants with known AGAs must have received appropriate targeted therapy, where available. * No more than 2 prior lines of cytotoxic chemotherapy for advanced disease * Cohort 3: Ovarian Cancer * Pathologically documented epithelial cancers of ovarian, fallopian tube, or peritoneal origin * Unresectable locally-advanced or metastatic stage disease * Prior therapies * Must have platinum resistant disease (6 months or less between the completion of platinum-based treatment and identification of recurrence) * Must not have received more than 4 lines of prior cytotoxic chemotherapies for advanced disease * Participants with known BRCA mutations are permitted, but participants must have received targeted therapy with a PARP inhibitor * May have received prior anti-PD(L)1 therapy * Cohort 4: Endometrial Cancer * Must have pathologically documented adenocarcinoma of the endometrium * Must have unresectable locally-advanced or metastatic stage disease. * Prior therapies * Must have relapsed/progressed after at least one prior platinum-based chemotherapy for recurrent, metastatic or primary unresectable disease * Must not have received more than 3 lines of prior cytotoxic chemotherapies for advanced disease * May have received prior anti-PD(L)1 therapy * HER2 expression of 1+, 2+, or 3+, as determined by local IHC testing on a fresh or archival tumor tissue. Note: Participants with HER2 mutations are eligible. * Measurable disease per RECIST v1.1 criteria as assessed by the investigator * Able to provide formalin-fixed, paraffin-embedded (FFPE) tumor tissue blocks (or freshly sectioned slides) * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 Exclusion Criteria: * Prior treatment with an MMAE-containing agent. * Known hypersensitivity to any excipient contained in the drug formulation of disitamab vedotin. * History of another invasive malignancy within 2 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy. * Active untreated CNS or leptomeningeal metastasis

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Conditions

The condition(s) this trial relates to.

endometrial cancer endometrium neoplasm head and neck cancer head and neck neoplasm Head and Neck Neoplasms non-small cell lung carcinoma ovarian cancer ovarian neoplasm

As listed by the trial registrant

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

Carcinoma, non-small-cell lung Endometrial neoplasms Head and neck neoplasms Ovarian neoplasms

Contacts and locations

Locations

  • Allina Health Cancer Institute (Virginia Piper Cancer Institute)

    Minneapolis, Minnesota, 55404, United States

  • Allina Health Cancer Institute-United(VPCI)

    Saint Paul, Minnesota, 55102, United States

  • Allina Health Cancer institute

    Coon Rapids, Minnesota, 55433, United States

  • Baxter Healthcare

    Old Toongabie, New South Wales, 2146, Australia

  • Blacktown Hospital

    Blacktown, 2148, Australia

  • Brigham and Women's Hospital (BWH)

    Boston, Massachusetts, 02115, United States

  • Centre Intégré de Cancérologie du CHU de Québec-Université Laval, Hôpital de l'Enfant-Jésus

    Québec, Quebec, G1J 1Z4, Canada

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050, Australia

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 28644, South Korea

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008, Spain

  • Clinica Universidad de Navarra Madrid

    Madrid, 28027, Spain

  • Dana-Farber Cancer Institute (DFCI)

    Boston, Massachusetts, 02215, United States

  • Dana-Farber Cancer Institute - Chestnut Hill

    Newton, Massachusetts, 02459, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Duke University Medical Center, Investigational Chemotherapy Services

    Durham, North Carolina, 27710, United States

  • Fondazione IRCCS San Gerardo dei Tintori.

    Monza (MB), Monza and Brianza, 20900, Italy

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109, United States

  • Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • Georgia Cancer Center at Augusta University

    Augusta, Georgia, 30912, United States

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415, United States

  • Hospital General Universitario Reina Sofia

    Córdoba, 14004, Spain

  • Hospital Provincial

    Córdoba, 14004, Spain

  • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

    Chandler, Arizona, 85224, United States

  • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

    Gilbert, Arizona, 85297, United States

  • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

    Glendale, Arizona, 85306, United States

  • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

    Mesa, Arizona, 85202, United States

  • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

    Mesa, Arizona, 85206, United States

  • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

    Phoenix, Arizona, 85028, United States

  • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

    Scottsdale, Arizona, 85260, United States

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Karmanos Cancer Institute Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334, United States

  • Laura & Isaac Perlmutter Cancer Center At NYU Langone

    New York, New York, 10016, United States

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016, United States

  • Laura & Issac Perlmutter Cancer Center-NYU Ambulatory Care Center(ACC)

    New York, New York, 10016, United States

  • M Health Fairview Cancer Clinic-Edina

    Edina, Minnesota, 55435, United States

  • M Health Fairview St. John's Hospital

    Maplewood, Minnesota, 55109, United States

  • Macquarie University Clinic

    Macquarie University, New South Wales, 2109, Australia

  • Macquarie University Clinical Trials Unit.

    Macquarie University, New South Wales, 2109, Australia

  • Macquarie University Hospital

    Macquarie University, New South Wales, 2109, Australia

  • Macquarie University Hospital Pharmacy

    Macquarie University, New South Wales, 2109, Australia

  • McGill University Health Centre

    Montreal, Quebec, H4A3J1, Canada

  • Minnesota Oncology Hematology, P.A.

    Burnsville, Minnesota, 55337, United States

  • Minnesota Oncology Hematology, P.A.

    Coon Rapids, Minnesota, 55433, United States

  • Minnesota Oncology Hematology, P.A.

    Edina, Minnesota, 55435, United States

  • Minnesota Oncology Hematology, P.A.

    Fridley, Minnesota, 55432, United States

  • Minnesota Oncology Hematology, P.A.

    Maple Grove, Minnesota, 55369, United States

  • Minnesota Oncology Hematology, P.A.

    Maplewood, Minnesota, 55109, United States

  • Minnesota Oncology Hematology, P.A.

    Minneapolis, Minnesota, 55404, United States

  • Minnesota Oncology Hematology, P.A. Cornerstone Medical Specialty Center

    Woodbury, Minnesota, 55125, United States

  • NYU Langone Hospital - Long Island

    Mineola, New York, 11501, United States

  • NYU Langone Hospital-Long Island

    Mineola, New York, 11501, United States

  • NYU Langone Hospitals

    New York, New York, 10016, United States

  • NYU Langone Hospitals, NYU Langone Rusk Ambulatory Surgical Pharmacy

    New York, New York, 10016, United States

  • NYU Langone Medical Center (Tisch Hospital)

    New York, New York, 10016, United States

  • North Memorial Health Cancer Center

    Robbinsdale, Minnesota, 55422, United States

  • Optimum Clinical Research Group, LLC

    Albuquerque, New Mexico, 87109, United States

  • PCM Trails

    Denver, Colorado, 80218, United States

  • PCM Trials

    Denver, Colorado, 80218, United States

  • Pacific Gynecology Specialists

    Seattle, Washington, 98104, United States

  • Park Nicollet Frauenshuh Cancer Center

    Saint Louis Park, Minnesota, 55426, United States

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

    Frankston, Victoria, 3199, Australia

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island

    Mineola, New York, 11501, United States

  • Providence Cancer Institute Franz Clinic

    Portland, Oregon, 97213, United States

  • Providence Medical Foundation

    Santa Rosa, California, 95403, United States

  • Providence Oncology and Hematology Care Clinic - Westside

    Portland, Oregon, 97225, United States

  • Providence Portland Medical Center

    Portland, Oregon, 97213, United States

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225, United States

  • Providence St. Vincent Medical Center- Investigational Drug Services

    Portland, Oregon, 97225, United States

  • Regions Hospital

    Saint Paul, Minnesota, 55101, United States

  • Regulatory location : MMCORC

    Saint Louis Park, Minnesota, 55426, United States

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Smilow Cancer Hospital Care Center at Trumbull

    Trumbull, Connecticut, 06611, United States

  • Smilow Cancer Hospital Phase 1 Unit

    New Haven, Connecticut, 06511, United States

  • Smilow Cancer Hospital at Yale - New Haven

    New Haven, Connecticut, 06510, United States

  • Southwest Women's Oncology Inc

    Albuquerque, New Mexico, 87109, United States

  • Swedish Cancer Institute

    Seattle, Washington, 98104, United States

  • Swedish First Hill IDS Pharmacy

    Seattle, Washington, 98104, United States

  • Swedish Medical Center

    Seattle, Washington, 98122, United States

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136, United States

  • Sylvester Comprehensive Cancer Center - Kendall

    Miami, Florida, 33176, United States

  • Sylvester Comprehensive Cancer Center Plantation

    Plantation, Florida, 33324, United States

  • Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center

    Coral Gables, Florida, 33146, United States

  • The Royal Marsden NHS Foundation Trust

    Sutton, Surrey, SM2 5PT, United Kingdom

  • The Royal Marsden NHS Foundation Trust (RM)

    Sutton, Surrey, SM2 5PT, United Kingdom

  • The Royal Marsden NHS Foundation Trust (RM)

    London, SW3 6JJ, United Kingdom

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of California Davis Comprehenvise Cancer Center

    Sacramento, California, 95817, United States

  • University of California Davis Medical Center

    Sacramento, California, 95817, United States

  • University of Miami Hospital and Clinics

    Miami, Florida, 33136, United States

  • University of Miami Hospital and Clinics Deerfield Beach

    Deerfield Beach, Florida, 33442, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067, United States

  • Valkyrie Clinical Trials(Additional Suite)

    Los Angeles, California, 90067, United States

  • Wellstar MCG Health Clinical Research Pharmacy

    Augusta, Georgia, 30912, United States

  • Yale Cancer Center

    New Haven, Connecticut, 06511, United States

  • Yale-New Haven Hospital-Yale Cancer Center

    New Haven, Connecticut, 06510, United States

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