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

April 19, 2024 updated by: Seagen Inc.

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 squamous cell cancer, non-small cell lung cancer, endometrial cancer, or ovarian cancer. 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

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 Contact

Study Locations

  • Australia
    • Other
      • Frankston, Other, Australia, 3199
        • Recruiting
        • Peninsula and South East Oncology
        • Principal Investigator:
          • Vinod Ganju
  • Canada
      • Quebec, Canada, G1J 1Z4
        • Recruiting
        • CHU de Quebec-Universite Laval
        • Principal Investigator:
          • Vincent Castonguay
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Department of Oncology / McGill University Health Centre
        • Principal Investigator:
          • Lucy Gilbert
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Recruiting
        • Ironwood Cancer & Research Centers - Chandler
        • Contact:
          • Devanie Heisler
          • Phone Number: 480-792-6033 x20195
        • Principal Investigator:
          • Sujith R Kalmadi
    • California
      • Los Angeles, California, United States, 90067
      • Santa Rosa, California, United States, 95403
        • Recruiting
        • Providence Medical Foundation
        • Principal Investigator:
          • Ian C Anderson
        • Contact:
          • Camille Shaffer
          • Phone Number: 707-521-3809
    • Colorado
      • Grand Junction, Colorado, United States, 81505
        • Recruiting
        • Colorado West Healthcare, dba Grand Valley Oncology
        • Principal Investigator:
          • Jonathan King
        • Contact:
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Recruiting
        • Yale Cancer Center
        • Contact:
        • Principal Investigator:
          • So Yeon Kim
      • Norwich, Connecticut, United States, 06360
        • Recruiting
        • Eastern CT Hematology and Oncology Associates
        • Principal Investigator:
          • Dennis Slater
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana Farber Cancer Institute
        • Contact:
        • Principal Investigator:
          • Joyce Liu
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Karmanos Cancer Institute / Wayne State University
        • Principal Investigator:
          • Ammar Sukari
        • Contact:
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55426
        • Recruiting
        • HealthPartners Institute
        • Principal Investigator:
          • Yan Ji
        • Contact:
    • Montana
      • Billings, Montana, United States, 59102
        • Recruiting
        • St. Vincent Frontier Cancer Center
        • Principal Investigator:
          • Patrick Cobb
        • Contact:
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Recruiting
        • Optimum Clinical Research Group, LLC (Southwest Women's Oncology)
        • Principal Investigator:
          • Karen Finkelstein
        • Contact:
    • New York
      • Mineola, New York, United States, 11501
        • Recruiting
        • NYU Langone Hospital
        • Principal Investigator:
          • Bhavana Pothuri
        • Contact:
          • Karen Estok
          • Phone Number: 212-404-4434
      • New York, New York, United States, 10016
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Contact:
        • Principal Investigator:
          • Niharika Mettu
    • Ohio
      • Canton, Ohio, United States, 44718
        • Recruiting
        • Gabrail Cancer Center Research, LLC
        • Contact:
        • Principal Investigator:
          • Nashat Gabrail
    • Oregon
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
        • Contact:
        • Principal Investigator:
          • Rachel E Sanborn
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Portland Medical Center
        • Contact:
        • Principal Investigator:
          • Rachel E Sanborn
    • Texas
      • El Paso, Texas, United States, 79915
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center / University of Texas
        • Principal Investigator:
          • Ecaterina E Ileana-Dumbrava
        • Contact:
      • The Woodlands, Texas, United States, 77380
        • Recruiting
        • Renovatio Clinical
        • Principal Investigator:
          • Jonathan Lu
        • Contact:
          • Pablo Villarreal
          • Phone Number: 713-703-2398
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Research Center | Seattle, WA
        • Contact:
        • Principal Investigator:
          • Diane Tseng, MD

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 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

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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 Inc.

Investigators

  • Study Director: Medical Monitor, Seagen Inc.

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 23, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGNDV-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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