A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2
NCT ID: NCT06003231
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2023-11-14
2028-05-31
Brief Summary
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This clinical trial uses an experimental drug called disitamab vedotin (DV). DV is a type of antibody-drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. In this study, all participants will get DV once every 2 weeks.
This study is being done to see if DV works to treat different types of solid tumors that express HER2. It will also test how safe the drug is for participants. This trial will also study what side effects happen when participants get the drug. A side effect is anything a drug does to your body besides treating the disease.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Head and neck cancer
Disitamab vedotin monotherapy
disitamab vedotin
Given into the vein (IV, intravenous) every 2 weeks
Non-small cell lung cancer
Disitamab vedotin monotherapy
disitamab vedotin
Given into the vein (IV, intravenous) every 2 weeks
Ovarian cancer
Disitamab vedotin monotherapy
disitamab vedotin
Given into the vein (IV, intravenous) every 2 weeks
Endometrial cancer
Disitamab vedotin monotherapy
disitamab vedotin
Given into the vein (IV, intravenous) every 2 weeks
Interventions
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disitamab vedotin
Given into the vein (IV, intravenous) every 2 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Seagen, a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Chandler, Arizona, United States
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Gilbert, Arizona, United States
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Glendale, Arizona, United States
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Mesa, Arizona, United States
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Mesa, Arizona, United States
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Phoenix, Arizona, United States
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Scottsdale, Arizona, United States
Valkyrie Clinical Trials(Additional Suite)
Los Angeles, California, United States
Valkyrie Clinical Trials
Los Angeles, California, United States
University of California Davis Comprehenvise Cancer Center
Sacramento, California, United States
University of California Davis Medical Center
Sacramento, California, United States
Providence Medical Foundation
Santa Rosa, California, United States
PCM Trials
Denver, Colorado, United States
Smilow Cancer Hospital at Yale - New Haven
New Haven, Connecticut, United States
Yale-New Haven Hospital-Yale Cancer Center
New Haven, Connecticut, United States
Smilow Cancer Hospital Phase 1 Unit
New Haven, Connecticut, United States
Yale Cancer Center
New Haven, Connecticut, United States
Smilow Cancer Hospital Care Center at Trumbull
Trumbull, Connecticut, United States
Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center
Coral Gables, Florida, United States
University of Miami Hospital and Clinics Deerfield Beach
Deerfield Beach, Florida, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
University of Miami Hospital and Clinics
Miami, Florida, United States
Sylvester Comprehensive Cancer Center - Kendall
Miami, Florida, United States
Sylvester Comprehensive Cancer Center Plantation
Plantation, Florida, United States
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States
Wellstar MCG Health Clinical Research Pharmacy
Augusta, Georgia, United States
Brigham and Women's Hospital (BWH)
Boston, Massachusetts, United States
Dana-Farber Cancer Institute (DFCI)
Boston, Massachusetts, United States
Dana-Farber Cancer Institute - Chestnut Hill
Newton, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Karmanos Cancer Institute Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States
Minnesota Oncology Hematology, P.A.
Burnsville, Minnesota, United States
Allina Health Cancer institute
Coon Rapids, Minnesota, United States
Minnesota Oncology Hematology, P.A.
Coon Rapids, Minnesota, United States
M Health Fairview Cancer Clinic-Edina
Edina, Minnesota, United States
Minnesota Oncology Hematology, P.A.
Edina, Minnesota, United States
Minnesota Oncology Hematology, P.A.
Fridley, Minnesota, United States
Minnesota Oncology Hematology, P.A.
Maple Grove, Minnesota, United States
M Health Fairview St. John's Hospital
Maplewood, Minnesota, United States
Minnesota Oncology Hematology, P.A.
Maplewood, Minnesota, United States
Allina Health Cancer Institute (Virginia Piper Cancer Institute)
Minneapolis, Minnesota, United States
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
North Memorial Health Cancer Center
Robbinsdale, Minnesota, United States
Park Nicollet Frauenshuh Cancer Center
Saint Louis Park, Minnesota, United States
Regulatory location : MMCORC
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
Allina Health Cancer Institute-United(VPCI)
Saint Paul, Minnesota, United States
Minnesota Oncology Hematology, P.A. Cornerstone Medical Specialty Center
Woodbury, Minnesota, United States
Optimum Clinical Research Group, LLC
Albuquerque, New Mexico, United States
Southwest Women's Oncology Inc
Albuquerque, New Mexico, United States
NYU Langone Hospital - Long Island
Mineola, New York, United States
NYU Langone Hospital-Long Island
Mineola, New York, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, United States
Laura & Isaac Perlmutter Cancer Center At NYU Langone
New York, New York, United States
Laura & Issac Perlmutter Cancer Center-NYU Ambulatory Care Center(ACC)
New York, New York, United States
NYU Langone Hospitals, NYU Langone Rusk Ambulatory Surgical Pharmacy
New York, New York, United States
NYU Langone Hospitals
New York, New York, United States
NYU Langone Medical Center (Tisch Hospital)
New York, New York, United States
Duke University Medical Center, Investigational Chemotherapy Services
Durham, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Providence Cancer Institute Franz Clinic
Portland, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence Oncology and Hematology Care Clinic - Westside
Portland, Oregon, United States
Providence St. Vincent Medical Center- Investigational Drug Services
Portland, Oregon, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Pacific Gynecology Specialists
Seattle, Washington, United States
Swedish Cancer Institute
Seattle, Washington, United States
Swedish First Hill IDS Pharmacy
Seattle, Washington, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Macquarie University Clinical Trials Unit.
Macquarie University, New South Wales, Australia
Macquarie University Clinic
Macquarie University, New South Wales, Australia
Macquarie University Hospital Pharmacy
Macquarie University, New South Wales, Australia
Macquarie University Hospital
Macquarie University, New South Wales, Australia
Baxter Healthcare
Old Toongabie, New South Wales, Australia
Peninsula & South Eastern Hematology and Oncology Group (PASO)
Frankston, Victoria, Australia
Blacktown Hospital
Blacktown, , Australia
McGill University Health Centre
Montreal, Quebec, Canada
Centre Intégré de Cancérologie du CHU de Québec-Université Laval, Hôpital de l'Enfant-Jésus
Québec, Quebec, Canada
Fondazione IRCCS San Gerardo dei Tintori.
Monza (MB), Monza and Brianza, Italy
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Samsung Medical Center
Seoul, , South Korea
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Hospital General Universitario Reina Sofia
Córdoba, , Spain
Hospital Provincial
Córdoba, , Spain
Clinica Universidad de Navarra Madrid
Madrid, , Spain
The Royal Marsden NHS Foundation Trust (RM)
Sutton, Surrey, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom
The Royal Marsden NHS Foundation Trust (RM)
London, , United Kingdom
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C5731005
Identifier Type: OTHER
Identifier Source: secondary_id
2023-504445-31-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
SGNDV-005
Identifier Type: -
Identifier Source: org_study_id