A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2
A Phase 2 Basket Study of Disitamab Vedotin in Adult Subjects With Previously Treated, Locally-Advanced Unresectable or Metastatic Solid Tumors That Express HER2
3 other identifiers
interventional
120
7 countries
94
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2023
Typical duration for phase_2
94 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2023
CompletedFirst Posted
Study publicly available on registry
August 21, 2023
CompletedStudy Start
First participant enrolled
November 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2028
March 16, 2026
March 1, 2026
2.5 years
August 15, 2023
March 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Confirmed Objective Response Rate (ORR) per Response Evaluation in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment
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 Outcomes (11)
Number of participants with adverse events (AEs)
Through 30-37 days after the last dose of DV; approximately 5 years
Number of participants with laboratories abnormalities
Through 30-37 days after the last dose of DV; approximately 5 years
Number of participants with dose alterations due to AEs
Approximately 5 years
Confirmed Disease Control Rate (DCR) per RECIST v1.1 by investigator assessment
Approximately 5 years
Duration of Response (DOR) per RECIST v1.1 by investigator assessment
Approximately 5 years
- +6 more secondary outcomes
Study Arms (4)
Head and neck cancer
EXPERIMENTALDisitamab vedotin monotherapy
Non-small cell lung cancer
EXPERIMENTALDisitamab vedotin monotherapy
Ovarian cancer
EXPERIMENTALDisitamab vedotin monotherapy
Endometrial cancer
EXPERIMENTALDisitamab vedotin monotherapy
Interventions
Given into the vein (IV, intravenous) every 2 weeks
Eligibility Criteria
You may qualify if:
- 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
- +17 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (94)
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
Valkyrie Clinical Trials(Additional Suite)
Los Angeles, California, 90067, United States
Valkyrie Clinical Trials
Los Angeles, California, 90067, 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
Providence Medical Foundation
Santa Rosa, California, 95403, United States
PCM Trials
Denver, Colorado, 80218, United States
Smilow Cancer Hospital at Yale - New Haven
New Haven, Connecticut, 06510, United States
Yale-New Haven Hospital-Yale Cancer Center
New Haven, Connecticut, 06510, United States
Smilow Cancer Hospital Phase 1 Unit
New Haven, Connecticut, 06511, United States
Yale Cancer Center
New Haven, Connecticut, 06511, United States
Smilow Cancer Hospital Care Center at Trumbull
Trumbull, Connecticut, 06611, United States
Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center
Coral Gables, Florida, 33146, United States
University of Miami Hospital and Clinics Deerfield Beach
Deerfield Beach, Florida, 33442, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
University of Miami Hospital and Clinics
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
Georgia Cancer Center at Augusta University
Augusta, Georgia, 30912, United States
Wellstar MCG Health Clinical Research Pharmacy
Augusta, Georgia, 30912, United States
Brigham and Women's Hospital (BWH)
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute (DFCI)
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute - Chestnut Hill
Newton, Massachusetts, 02459, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Karmanos Cancer Institute Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334, United States
Minnesota Oncology Hematology, P.A.
Burnsville, Minnesota, 55337, United States
Allina Health Cancer institute
Coon Rapids, Minnesota, 55433, United States
Minnesota Oncology Hematology, P.A.
Coon Rapids, Minnesota, 55433, United States
M Health Fairview Cancer Clinic-Edina
Edina, Minnesota, 55435, 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
M Health Fairview St. John's Hospital
Maplewood, Minnesota, 55109, United States
Minnesota Oncology Hematology, P.A.
Maplewood, Minnesota, 55109, United States
Allina Health Cancer Institute (Virginia Piper Cancer Institute)
Minneapolis, Minnesota, 55404, United States
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, 55404, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
North Memorial Health Cancer Center
Robbinsdale, Minnesota, 55422, United States
Park Nicollet Frauenshuh Cancer Center
Saint Louis Park, Minnesota, 55426, United States
Regulatory location : MMCORC
Saint Louis Park, Minnesota, 55426, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
Allina Health Cancer Institute-United(VPCI)
Saint Paul, Minnesota, 55102, United States
Minnesota Oncology Hematology, P.A. Cornerstone Medical Specialty Center
Woodbury, Minnesota, 55125, United States
Optimum Clinical Research Group, LLC
Albuquerque, New Mexico, 87109, United States
Southwest Women's Oncology Inc
Albuquerque, New Mexico, 87109, United States
NYU Langone Hospital - Long Island
Mineola, New York, 11501, United States
NYU Langone Hospital-Long Island
Mineola, New York, 11501, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, 11501, United States
Laura & Isaac Perlmutter Cancer Center At NYU Langone
New York, New York, 10016, United States
Laura & Issac Perlmutter Cancer Center-NYU Ambulatory Care Center(ACC)
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 Hospitals
New York, New York, 10016, United States
NYU Langone Medical Center (Tisch Hospital)
New York, New York, 10016, United States
Duke University Medical Center, Investigational Chemotherapy Services
Durham, North Carolina, 27710, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Providence Oncology and Hematology Care Clinic - Westside
Portland, Oregon, 97225, United States
Providence St. Vincent Medical Center- Investigational Drug Services
Portland, Oregon, 97225, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Pacific Gynecology Specialists
Seattle, Washington, 98104, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Swedish First Hill IDS Pharmacy
Seattle, Washington, 98104, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050, Australia
Macquarie University Clinical Trials Unit.
Macquarie University, New South Wales, 2109, Australia
Macquarie University Clinic
Macquarie University, New South Wales, 2109, Australia
Macquarie University Hospital Pharmacy
Macquarie University, New South Wales, 2109, Australia
Macquarie University Hospital
Macquarie University, New South Wales, 2109, Australia
Baxter Healthcare
Old Toongabie, New South Wales, 2146, Australia
Peninsula & South Eastern Hematology and Oncology Group (PASO)
Frankston, Victoria, 3199, Australia
Blacktown Hospital
Blacktown, 2148, Australia
McGill University Health Centre
Montreal, Quebec, H4A3J1, Canada
Centre Intégré de Cancérologie du CHU de Québec-Université Laval, Hôpital de l'Enfant-Jésus
Québec, Quebec, G1J 1Z4, Canada
Fondazione IRCCS San Gerardo dei Tintori.
Monza (MB), Monza and Brianza, 20900, Italy
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, 28644, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Clinica Universidad de Navarra
Pamplona, Navarre, 31008, Spain
Hospital General Universitario Reina Sofia
Córdoba, 14004, Spain
Hospital Provincial
Córdoba, 14004, Spain
Clinica Universidad de Navarra Madrid
Madrid, 28027, Spain
The Royal Marsden NHS Foundation Trust (RM)
Sutton, Surrey, SM2 5PT, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT, United Kingdom
The Royal Marsden NHS Foundation Trust (RM)
London, SW3 6JJ, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2023
First Posted
August 21, 2023
Study Start
November 14, 2023
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2028
Last Updated
March 16, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
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.