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

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ClinicalTrials.gov Identifier: NCT06003231
Recruitment Status : Recruiting
First Posted : August 21, 2023
Last Update Posted : April 23, 2024
Sponsor:
Information provided by (Responsible Party):
Seagen Inc.

Study Description
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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 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.


Condition or disease Intervention/treatment Phase
Carcinoma, Squamous Cell of Head and Neck Carcinoma, Non-Small-Cell Lung Ovarian Neoplasms Endometrial Neoplasms Drug: disitamab vedotin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 14, 2023
Estimated Primary Completion Date : May 31, 2026
Estimated Study Completion Date : May 31, 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Disitamab vedotin monotherapy
Disitamab vedotin monotherapy
 Drug: disitamab vedotin
Given into the vein (IV, intravenous) every 2 weeks
Other Name: RC48, RC48-ADC


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Number of participants with laboratories abnormalities [ Time Frame: Through 30-37 days after the last dose of DV; approximately 5 years ]
  3. Number of participants with dose alterations due to AEs [ Time Frame: Approximately 5 years ]
  4. 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

  5. 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

  6. 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

  7. 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

  8. 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.

  9. 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.

  10. 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.

  11. Incidence of antidrug antibodies (ADAs) [ Time Frame: Through 30-37 days after the last dose of DV; approximately 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06003231


Contacts
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Contact: Seagen Trial Information Support 866-333-7436 clinicaltrials@seagen.com

Locations
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Sponsors and Collaborators
Seagen Inc.
Investigators
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Study Director: Medical Monitor Seagen Inc.
More Information
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Responsible Party: Seagen Inc.
ClinicalTrials.gov Identifier: NCT06003231    
Other Study ID Numbers: SGNDV-005
First Posted: August 21, 2023    Key Record Dates
Last Update Posted: April 23, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seagen Inc.:
HNSCC
NSCLC
Ovarian Cancer
Endometrial Cancer
Additional relevant MeSH terms:
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Carcinoma
Neoplasms
Carcinoma, Non-Small-Cell Lung
Ovarian Neoplasms
Carcinoma, Squamous Cell
Endometrial Neoplasms
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Lung Diseases
Respiratory Tract Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Squamous Cell