Clinical trial NCT06003231: A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2
Official title: A Phase 2 Basket Study of Disitamab Vedotin in Adult Subjects With Previously Treated, Locally-Advanced Unresectable or Metastatic Solid Tumors That Express HER2
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Ovarian Neoplasms
Endometrial Neoplasms
Head and Neck Neoplasms
Keywords: NSCLC
Ovarian Cancer
Endometrial Cancer
Head and Neck Cancer
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-21
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Confirmed Objective Response Rate (ORR) per Response Evaluation in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment
timeFrame: Approximately 3 years
Secondary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Through 30-37 days after the last dose of DV; approximately 5 years
measure: Number of participants with laboratories abnormalities
timeFrame: Through 30-37 days after the last dose of DV; approximately 5 years
measure: Number of participants with dose alterations due to AEs
timeFrame: Approximately 5 years
measure: Confirmed Disease Control Rate (DCR) per RECIST v1.1 by investigator assessment
timeFrame: Approximately 5 years
measure: Duration of Response (DOR) per RECIST v1.1 by investigator assessment
timeFrame: Approximately 5 years
measure: Progression free survival (PFS) per RECIST v1.1 by investigator assessment
timeFrame: Approximately 5 years
measure: Overall Survival (OS)
timeFrame: Approximately 5 years
measure: Pharmacokinetic (PK) parameter - Area under the concentration-time curve to the time of the last quantifiable concentration (AUClast)
timeFrame: Approximately 1 month
measure: PK parameter - Maximum concentration (Cmax)
timeFrame: Through 30-37 days after the last dose of DV; approximately 5 years
measure: PK parameter - Trough concentration (Ctrough)
timeFrame: Through 30-37 days after the last dose of DV; approximately 5 years
measure: Incidence of antidrug antibodies (ADAs)
timeFrame: Through 30-37 days after the last dose of DV; approximately 5 years
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
state: Arizona
city: Gilbert
country: United States
facility: Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
state: Arizona
city: Glendale
country: United States
facility: Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
state: Arizona
city: Mesa
country: United States
facility: Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
state: Arizona
city: Mesa
country: United States
facility: Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
state: Arizona
city: Phoenix
country: United States
facility: Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
state: Arizona
city: Scottsdale
country: United States
facility: Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
state: Arizona
city: Los Angeles
country: United States
facility: Valkyrie Clinical Trials
state: California
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
city: Santa Rosa
country: United States
facility: Providence Medical Foundation
state: California
city: Grand Junction
country: United States
facility: Colorado West Healthcare System, dba Community Hospital
state: Colorado
city: New Haven
country: United States
facility: Smilow Cancer Hospital at Yale - New Haven
state: Connecticut
city: New Haven
country: United States
facility: Yale-New Haven Hospital-Yale Cancer Center
state: Connecticut
city: New Haven
country: United States
facility: Smilow Cancer Hospital Phase 1 Unit
state: Connecticut
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Trumbull
country: United States
facility: Smilow Cancer Hospital Care Center at Trumbull
state: Connecticut
city: Coral Gables
country: United States
facility: Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center
state: Florida
city: Deerfield Beach
country: United States
facility: University of Miami Hospital and Clinics Deerfield Beach
state: Florida
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital And Clinics
state: Florida
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center - Kendall
state: Florida
city: Plantation
country: United States
facility: Sylvester Comprehensive Cancer Center Plantation
state: Florida
city: Augusta
country: United States
facility: Georgia Cancer Center at Augusta University
state: Georgia
city: Augusta
country: United States
facility: Wellstar MCG Health Clinical Research Pharmacy
state: Georgia
city: Baltimore
country: United States
facility: IDS Pharmacy Room NGW516/506
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland Greenebaum Comprehensive Cancer Center
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland Medical System
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Institute (DFCI)
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital (BWH)
state: Massachusetts
city: Newton
country: United States
facility: Dana-Farber Cancer Institute - Chestnut Hill
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Farmington Hills
country: United States
facility: Karmanos Cancer Institute Weisberg Cancer Treatment Center
state: Michigan
city: Burnsville
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: Coon Rapids
country: United States
facility: Allina Health Cancer institute
state: Minnesota
city: Coon Rapids
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: Edina
country: United States
facility: M Health Fairview Cancer Clinic-Edina
state: Minnesota
city: Edina
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: Fridley
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: Maple Grove
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: Maplewood
country: United States
facility: M Health Fairview St. John's Hospital
state: Minnesota
city: Maplewood
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: Minneapolis
country: United States
facility: Allina Health Cancer Institute (Virginia Piper Cancer Institute)
state: Minnesota
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Robbinsdale
country: United States
facility: North Memorial Health Cancer Center
state: Minnesota
city: Saint Louis Park
country: United States
facility: Park Nicollet Frauenshuh Cancer Center
state: Minnesota
city: Saint Louis Park
country: United States
facility: Regulatory location : MMCORC
state: Minnesota
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Saint Paul
country: United States
facility: Allina Health Cancer Institute-United(VPCI)
state: Minnesota
city: Woodbury
country: United States
facility: Minnesota Oncology Hematology, P.A. Cornerstone Medical Specialty Center
state: Minnesota
city: Billings
country: United States
facility: Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana
state: Montana
city: Billings
country: United States
facility: Intermountain Health St. Vincent Regional Hospital
state: Montana
city: Billings
country: United States
facility: Intermountain Health - West End Clinic Gynecologic Oncology
state: Montana
city: Albuquerque
country: United States
facility: Optimum Clinical Research Group, LLC
state: New Mexico
city: Albuquerque
country: United States
facility: Southwest Women's Oncology Inc
state: New Mexico
city: Mineola
country: United States
facility: NYU Langone Hospital - Long Island
state: New York
city: Mineola
country: United States
facility: NYU Langone Hospital-Long Island
state: New York
city: Mineola
country: United States
facility: Perlmutter Cancer Center at NYU Langone Hospital - Long Island
state: New York
city: New York
country: United States
facility: The Blavatnik Family-Chelsea Medical Center at Mount Sinai
state: New York
city: New York
country: United States
facility: Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
state: New York
city: New York
country: United States
facility: Laura & Issac Perlmutter Cancer Center-NYU Ambulatory Care Center(ACC)
state: New York
city: New York
country: United States
facility: New York University (NYU) Cancer Institute
state: New York
city: New York
country: United States
facility: NYU Langone Hospitals
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center (Tisch Hospital)
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Ruttenberg Treatment Center
state: New York
city: New York
country: United States
facility: The Mount Sinai Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center, Investigational Chemotherapy Services
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center Research
state: Ohio
city: Portland
country: United States
facility: Providence Cancer Institute Franz Clinic
state: Oregon
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Portland
country: United States
facility: Providence St. Vincent Medical Center- Investigational Drug Services
state: Oregon
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center - Simmons Cancer Center
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center-Zale Lipshy University Hospital
state: Texas
city: Dallas
country: United States
facility: University Of Texas Southwestern Medical Center
state: Texas
city: El Paso
country: United States
facility: Renovatio Clinical- Dr. Haroutioun Shahinian, MD, PA
state: Texas
city: El Paso
country: United States
facility: Renovatio Clinical.
state: Texas
city: Fort Worth
country: United States
facility: University of Texas Southwestern Simmons Cancer Center - Fort Worth
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Richardson
country: United States
facility: University of Texas Southwestern Simmons Cancer Center - Richardson/Plano
state: Texas
city: Spring
country: United States
facility: Renovatio Clinical - Genesis Medical Group
state: Texas
city: The Woodlands
country: United States
facility: Renovatio Clinical - Genesis Medical Group
state: Texas
city: The Woodlands
country: United States
facility: Renovatio Clinical
state: Texas
city: Tomball
country: United States
facility: Renovatio Clinical - Genesis Medical Group
state: Texas
city: Seattle
country: United States
facility: Pacific Gynecology Specialists
state: Washington
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Seattle
country: United States
facility: Swedish First Hill IDS Pharmacy
state: Washington
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center | Seattle, WA
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Blacktown
country: Australia
facility: Blacktown Hospital
state: New South Wales
city: Macquarie
country: Australia
facility: Macquarie University Clinical Trials Unit.
state: New South Wales
city: Macquarie
country: Australia
facility: Macquarie University Clinic
state: New South Wales
city: Macquarie
country: Australia
facility: Macquarie University Hospital Pharmacy
state: New South Wales
city: Macquarie
country: Australia
facility: Macquarie University Hospital
state: New South Wales
city: Old Toongabbie
country: Australia
facility: Baxter Healthcare
state: New South Wales
city: Frankston
country: Australia
facility: Peninsula & South Eastern Hematology and Oncology Group (PASO)
state: Victoria
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Quebec
country: Canada
facility: CHU de Québec-Université Laval
city: Bonn
country: Germany
facility: Johanniter GmbH, Johanniter Krankenhaus Bonn
state: NRW
city: Berlin
country: Germany
facility: Charite Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Charite Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Charite Berlin-Campus Virchow
city: Bonn
country: Germany
facility: Johanniter Krankenhaus Bonn
city: Wesseling
country: Germany
facility: Kronen - Apotheke Marxen
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori.
state: Monza AND Brianza
city: Verona
country: Italy
facility: UOC Radiologia BR - AOUI Verona
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata di Verona
city: Verona
country: Italy
facility: Centro Ricerche Cliniche Verona s.r.l. presso Ospedale G.B. Rossi Borgo Roma
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungcheongbuk-do
city: Seongnam-si
country: Korea, Republic of
facility: CHA University CHA Bundang Medical Center
state: Gyeonggi-do
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Grupo Hospitalario Quiron
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D Hebron
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Cordoba
country: Spain
facility: Hospital Provincial
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra Madrid
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust (RM)
state: Surrey
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust (RM)
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: