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

Registration Number
NCT06003231
Lead Sponsor
Seagen Inc.
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 squamous cell cancer, non-small cell lung cancer, endometrial cancer, or ovarian cancer. Participants...

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
160
Inclusion Criteria
  • Cohort 1: Head and neck squamous cell carcinoma (HNSCC)

    • Pathologically-documented squamous cell carcinoma of the head and neck with primary tumor site arising from the oral cavity, oropharynx, hypopharynx, and larynx

    • Unresectable locally recurrent or metastatic stage disease

    • Prior therapies:

      • Participants must have disease progression after treatment with a platinum-based therapy
      • No more than 1 line of cytotoxic chemotherapy for advanced disease
  • 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 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
      • 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
      • 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

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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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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Disitamab vedotin monotherapydisitamab vedotinDisitamab vedotin monotherapy
Primary Outcome Measures
NameTimeMethod
Confirmed Objective Response Rate (ORR) per Response Evaluation in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessmentApproximately 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

Secondary Outcome Measures
NameTimeMethod
Number of participants with laboratories abnormalitiesThrough 30-37 days after the last dose of DV; approximately 5 years
Overall Survival (OS)Approximately 5 years

The time from the start of study treatment to the date of death due to any cause

Number of participants with adverse events (AEs)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

PK parameter - Maximum concentration (Cmax)Through 30-37 days after the last dose of DV; approximately 5 years

Analyzed through end of treatment.

Incidence of antidrug antibodies (ADAs)Through 30-37 days after the last dose of DV; approximately 5 years
Number of participants with dose alterations due to AEsApproximately 5 years
Confirmed Disease Control Rate (DCR) per RECIST v1.1 by investigator assessmentApproximately 5 years

The proportion of participants with stable disease (SD) or confirmed CR or PR according to RECIST v1.1

PK parameter - Trough concentration (Ctrough)Through 30-37 days after the last dose of DV; approximately 5 years

Analyzed through end of treatment.

Duration of Response (DOR) per RECIST v1.1 by investigator assessmentApproximately 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

Pharmacokinetic (PK) parameter - Area under the concentration-time curve to the time of the last quantifiable concentration (AUClast)Approximately 1 month

Analyzed through cycle 2.

Progression free survival (PFS) per RECIST v1.1 by investigator assessmentApproximately 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

Trial Locations

Locations (45)

Fondazione IRCCS San Gerardo dei Tintori

🇮🇹

Monza, Other, Italy

Guy's and St Thomas' NHS Foundation

🇬🇧

London, Other, United Kingdom

Ironwood Cancer & Research Centers - Chandler

🇺🇸

Chandler, Arizona, United States

Valkyrie Clinical Trials

🇺🇸

Los Angeles, California, United States

University of California Davis

🇺🇸

Sacramento, California, United States

Providence Medical Foundation

🇺🇸

Santa Rosa, California, United States

Colorado West Healthcare, dba Grand Valley Oncology

🇺🇸

Grand Junction, Colorado, United States

Yale Cancer Center

🇺🇸

New Haven, Connecticut, United States

Eastern CT Hematology and Oncology Associates

🇺🇸

Norwich, Connecticut, United States

University of Miami

🇺🇸

Miami, Florida, United States

Augusta University

🇺🇸

Augusta, Georgia, United States

Dana Farber Cancer Institute

🇺🇸

Boston, Massachusetts, United States

Karmanos Cancer Institute / Wayne State University

🇺🇸

Detroit, Michigan, United States

HealthPartners Institute

🇺🇸

Saint Louis Park, Minnesota, United States

St. Vincent Frontier Cancer Center

🇺🇸

Billings, Montana, United States

Optimum Clinical Research Group, LLC (Southwest Women's Oncology)

🇺🇸

Albuquerque, New Mexico, United States

NYU Langone Hospital

🇺🇸

New York, New York, United States

Mount Sinai Medical Center

🇺🇸

New York, New York, United States

Ruttenberg Treatment Center, Icahn School of Medicine at Mount Sinai

🇺🇸

New York, New York, United States

Duke University Medical Center

🇺🇸

Durham, North Carolina, United States

Gabrail Cancer Center Research

🇺🇸

Canton, Ohio, United States

Providence Portland Medical Center

🇺🇸

Portland, Oregon, United States

University of Texas Southwestern Medical Center

🇺🇸

Dallas, Texas, United States

Renovatio Clinical

🇺🇸

The Woodlands, Texas, United States

MD Anderson Cancer Center / University of Texas

🇺🇸

Houston, Texas, United States

Swedish Cancer Institute

🇺🇸

Seattle, Washington, United States

Fred Hutchinson Cancer Research Center | Seattle, WA

🇺🇸

Seattle, Washington, United States

Blacktown Hospital

🇦🇺

Blacktown NSW, Other, Australia

Macquarie University Hospital

🇦🇺

Brisbane, Other, Australia

Chris O'Brien Lifehouse

🇦🇺

Camperdown, Other, Australia

Peninsula and South East Oncology

🇦🇺

Frankston, Other, Australia

University Health Network, Princess Margaret Hospital

🇨🇦

Toronto, Ontario, Canada

McGill University Department of Oncology / McGill University Health Centre

🇨🇦

Montreal, Quebec, Canada

CHU de Quebec-Universite Laval

🇨🇦

Quebec, Canada

Chungbuk National University Hospital

🇰🇷

Cheongju-si, Other, Korea, Republic of

Gachon University Gil Medical Center

🇰🇷

Incheon, Other, Korea, Republic of

CHA Bundang Medical Center

🇰🇷

Seongnam, Other, Korea, Republic of

Asan Medical Center

🇰🇷

Seoul, Other, Korea, Republic of

Sungkyunkwan University of Medicine - Samsung Changwon Hospital

🇰🇷

Seoul, Other, Korea, Republic of

Hospital del Mar

🇪🇸

Barcelona, Other, Spain

Hospital Universitario Reina Sofia

🇪🇸

Cordoba, Other, Spain

Clinica Universidad de Navarra

🇪🇸

Pamplona, Other, Spain

University College London Hospitals NHS Foundation Trust

🇬🇧

London, Other, United Kingdom

The Royal Marsden NHS Foundation Trust (RM)

🇬🇧

London, Other, United Kingdom

Royal Marsden Hospital Sutton

🇬🇧

Sutton, Other, United Kingdom

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