A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2

April 6, 2026 updated by: Seagen, a wholly owned subsidiary of Pfizer

A Phase 2 Basket Study of Disitamab Vedotin in Adult Subjects With Previously Treated, Locally-Advanced Unresectable or Metastatic Solid Tumors That Express HER2

This clinical trial is studying advanced or metastatic solid tumors. Once a solid tumor has grown very large in one spot or has spread to other places in the body, it is called advanced or metastatic cancer. Participants in this study must have head and neck cancer, non-small cell lung cancer, endometrial cancer, or ovarian cancer. In the first part of the study, participants must have tumors that have a marker called HER2.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Blacktown, Australia, 2148
        • Blacktown Hospital
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Chris O'Brien Lifehouse
      • Macquarie University, New South Wales, Australia, 2109
        • Macquarie University Hospital
      • Macquarie University, New South Wales, Australia, 2109
        • Macquarie University Hospital Pharmacy
      • Macquarie University, New South Wales, Australia, 2109
        • Macquarie University Clinical Trials Unit.
      • Macquarie University, New South Wales, Australia, 2109
        • Macquarie University Clinic
      • Old Toongabie, New South Wales, Australia, 2146
        • Baxter Healthcare
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Peninsula & South Eastern Hematology and Oncology Group (PASO)
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4A3J1
        • McGill University Health Centre
      • Québec, Quebec, Canada, G1J 1Z4
        • Centre Intégré de Cancérologie du CHU de Québec-Université Laval, Hôpital de l'Enfant-Jésus
  • Italy
    • Monza and Brianza
      • Monza (MB), Monza and Brianza, Italy, 20900
        • Fondazione IRCCS San Gerardo dei Tintori.
  • South Korea
      • Incheon, South Korea, 21565
        • Gachon University Gil Medical Center
      • Seoul, South Korea, 06351
        • Samsung Medical Center
    • North Chungcheong
      • Cheongju-si, North Chungcheong, South Korea, 28644
        • Chungbuk National University Hospital
  • Spain
      • Córdoba, Spain, 14004
        • Hospital Provincial
      • Córdoba, Spain, 14004
        • Hospital General Universitario Reina Sofia
      • Madrid, Spain, 28027
        • Clinica Universidad de Navarra Madrid
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Clinica Universidad de Navarra
  • United Kingdom
      • London, United Kingdom, SW3 6JJ
        • The Royal Marsden NHS Foundation Trust (RM)
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • The Royal Marsden NHS Foundation Trust
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • The Royal Marsden NHS Foundation Trust (RM)
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
      • Gilbert, Arizona, United States, 85297
        • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
      • Glendale, Arizona, United States, 85306
        • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
      • Mesa, Arizona, United States, 85206
        • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
      • Mesa, Arizona, United States, 85202
        • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
      • Phoenix, Arizona, United States, 85028
        • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
      • Scottsdale, Arizona, United States, 85260
        • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
    • California
      • Los Angeles, California, United States, 90067
        • Valkyrie Clinical Trials
      • Los Angeles, California, United States, 90067
        • Valkyrie Clinical Trials(Additional Suite)
      • Sacramento, California, United States, 95817
        • University of California Davis Medical Center
      • Sacramento, California, United States, 95817
        • University of California Davis Comprehenvise Cancer Center
      • Santa Rosa, California, United States, 95403
        • Providence Medical Foundation
    • Colorado
      • Denver, Colorado, United States, 80218
        • PCM Trials
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale Cancer Center
      • New Haven, Connecticut, United States, 06511
        • Smilow Cancer Hospital Phase 1 Unit
      • New Haven, Connecticut, United States, 06510
        • Smilow Cancer Hospital at Yale - New Haven
      • New Haven, Connecticut, United States, 06510
        • Yale-New Haven Hospital-Yale Cancer Center
      • Trumbull, Connecticut, United States, 06611
        • Smilow Cancer Hospital Care Center at Trumbull
    • Florida
      • Coral Gables, Florida, United States, 33146
        • Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center
      • Deerfield Beach, Florida, United States, 33442
        • University of Miami Hospital and Clinics Deerfield Beach
      • Miami, Florida, United States, 33136
        • Sylvester Comprehensive Cancer Center
      • Miami, Florida, United States, 33136
        • University of Miami Hospital and Clinics
      • Miami, Florida, United States, 33176
        • Sylvester Comprehensive Cancer Center - Kendall
      • Plantation, Florida, United States, 33324
        • Sylvester Comprehensive Cancer Center Plantation
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Georgia Cancer Center at Augusta University
      • Augusta, Georgia, United States, 30912
        • Wellstar MCG Health Clinical Research Pharmacy
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute (DFCI)
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital (BWH)
      • Newton, Massachusetts, United States, 02459
        • Dana-Farber Cancer Institute - Chestnut Hill
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
      • Farmington Hills, Michigan, United States, 48334
        • Karmanos Cancer Institute Weisberg Cancer Treatment Center
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Minnesota Oncology Hematology, P.A.
      • Coon Rapids, Minnesota, United States, 55433
        • Minnesota Oncology Hematology, P.A.
      • Coon Rapids, Minnesota, United States, 55433
        • Allina Health Cancer Institute
      • Edina, Minnesota, United States, 55435
        • Minnesota Oncology Hematology, P.A.
      • Edina, Minnesota, United States, 55435
        • M Health Fairview Cancer Clinic-Edina
      • Fridley, Minnesota, United States, 55432
        • Minnesota Oncology Hematology, P.A.
      • Maple Grove, Minnesota, United States, 55369
        • Minnesota Oncology Hematology, P.A.
      • Maplewood, Minnesota, United States, 55109
        • Minnesota Oncology Hematology, P.A.
      • Maplewood, Minnesota, United States, 55109
        • M Health Fairview St. John's Hospital
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, United States, 55404
        • Minnesota Oncology Hematology, P.A.
      • Minneapolis, Minnesota, United States, 55404
        • Allina Health Cancer Institute (Virginia Piper Cancer Institute)
      • Robbinsdale, Minnesota, United States, 55422
        • North Memorial Health Cancer Center
      • Saint Louis Park, Minnesota, United States, 55426
        • Park Nicollet Frauenshuh Cancer Center
      • Saint Louis Park, Minnesota, United States, 55426
        • Regulatory location : MMCORC
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, United States, 55102
        • Allina Health Cancer Institute-United(VPCI)
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Oncology Hematology, P.A. Cornerstone Medical Specialty Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Optimum Clinical Research Group, LLC
      • Albuquerque, New Mexico, United States, 87109
        • Southwest Women's Oncology Inc
    • New York
      • Mineola, New York, United States, 11501
        • NYU Langone Hospital - Long Island
      • Mineola, New York, United States, 11501
        • NYU Langone Hospital-Long Island
      • Mineola, New York, United States, 11501
        • Perlmutter Cancer Center at NYU Langone Hospital - Long Island
      • New York, New York, United States, 10016
        • NYU Langone Medical Center (Tisch Hospital)
      • New York, New York, United States, 10016
        • Laura & Isaac Perlmutter Cancer Center at NYU Langone
      • New York, New York, United States, 10016
        • NYU Langone Hospitals
      • New York, New York, United States, 10016
        • NYU Langone Hospitals, NYU Langone Rusk Ambulatory Surgical Pharmacy
      • New York, New York, United States, 10016
        • Laura & Issac Perlmutter Cancer Center-NYU Ambulatory Care Center(ACC)
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center, Investigational Chemotherapy Services
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Cancer Institute Franz Clinic
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, United States, 97225
        • Providence St. Vincent Medical Center
      • Portland, Oregon, United States, 97225
        • Providence Oncology and Hematology Care Clinic - Westside
      • Portland, Oregon, United States, 97225
        • Providence St. Vincent Medical Center- Investigational Drug Services
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute
      • Seattle, Washington, United States, 98104
        • Pacific Gynecology Specialists
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Center
      • Seattle, Washington, United States, 98104
        • Swedish First Hill IDS Pharmacy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Head and neck cancer
Disitamab vedotin monotherapy
Drug: disitamab vedotin
Given into the vein (IV, intravenous) every 2 weeks
Other Names:
  • RC48, RC48-ADC
Experimental: Non-small cell lung cancer
Disitamab vedotin monotherapy
Drug: disitamab vedotin
Given into the vein (IV, intravenous) every 2 weeks
Other Names:
  • RC48, RC48-ADC
Experimental: Ovarian cancer
Disitamab vedotin monotherapy
Drug: disitamab vedotin
Given into the vein (IV, intravenous) every 2 weeks
Other Names:
  • RC48, RC48-ADC
Experimental: Endometrial cancer
Disitamab vedotin monotherapy
Drug: disitamab vedotin
Given into the vein (IV, intravenous) every 2 weeks
Other Names:
  • RC48, RC48-ADC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Confirmed Objective Response Rate (ORR) per Response Evaluation in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment
Time Frame: Approximately 3 years
The proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the investigator
Approximately 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events (AEs)
Time Frame: Through 30-37 days after the last dose of DV; approximately 5 years
Any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention
Through 30-37 days after the last dose of DV; approximately 5 years
Number of participants with laboratories abnormalities
Time Frame: Through 30-37 days after the last dose of DV; approximately 5 years
Through 30-37 days after the last dose of DV; approximately 5 years
Number of participants with dose alterations due to AEs
Time Frame: Approximately 5 years
Approximately 5 years
Confirmed Disease Control Rate (DCR) per RECIST v1.1 by investigator assessment
Time Frame: Approximately 5 years
The proportion of participants with stable disease (SD) or confirmed CR or PR according to RECIST v1.1
Approximately 5 years
Duration of Response (DOR) per RECIST v1.1 by investigator assessment
Time Frame: Approximately 5 years
The time from start of the first documentation of objective tumor response of CR or PR (that is subsequently confirmed) to the first documentation of progressive disease (PD) per RECIST v1.1, or to death due to any cause
Approximately 5 years
Overall Survival (OS)
Time Frame: Approximately 5 years
The time from the start of study treatment to the date of death due to any cause
Approximately 5 years
Pharmacokinetic (PK) parameter - Area under the concentration-time curve to the time of the last quantifiable concentration (AUClast)
Time Frame: Approximately 1 month
Analyzed through cycle 2.
Approximately 1 month
PK parameter - Maximum concentration (Cmax)
Time Frame: Through 30-37 days after the last dose of DV; approximately 5 years
Analyzed through end of treatment.
Through 30-37 days after the last dose of DV; approximately 5 years
PK parameter - Trough concentration (Ctrough)
Time Frame: Through 30-37 days after the last dose of DV; approximately 5 years
Analyzed through end of treatment.
Through 30-37 days after the last dose of DV; approximately 5 years
Incidence of antidrug antibodies (ADAs)
Time Frame: Through 30-37 days after the last dose of DV; approximately 5 years
Through 30-37 days after the last dose of DV; approximately 5 years
Progression free survival (PFS) per RECIST v1.1 by investigator assessment
Time Frame: Approximately 5 years
PFS is defined as the time from the start of study treatment to the first documentation of PD per RECIST v1.1 or death due to any cause, whichever occurs first
Approximately 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen, a wholly owned subsidiary of Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2023

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2028

Study Registration Dates

First Submitted

August 15, 2023

First Submitted That Met QC Criteria

August 15, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGNDV-005
  • C5731005 (Other Identifier: Alias Study Number)
  • 2023-504445-31-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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