The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.

Clinical Trial Details

Geo Regions

Category

Other or Multiple Cancer Types

Disitamab vedotin

Disitamab vedotin is an investigational compound. Its safety and efficacy have not been established.

A Phase 2 Basket Study of Disitamab Vedotin in Adult Subjects With Previously Treated, Locally-Advanced Unresectable or Metastatic Solid Tumors That Express HER2
Phase 2
NCT06003231

Active enrolling

Globe
Locations

United States, Australia, Canada

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Study design

Participant Group/Arm

EXPERIMENTAL: Disitamab vedotin monotherapy

Disitamab vedotin monotherapy

Intervention/Treatment

DRUG: disitamab vedotin

Given into the vein (IV, intravenous) every 2 weeks
Study design table for Clinical Trial

Key eligibility 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:
  • Cohort 2: Non-small cell lung cancer (NSCLC)
    • Pathologically documented NSCLC
    • Unresectable locally-advanced or metastatic stage disease
    • Prior therapies
  • Cohort 3: Ovarian Cancer
    • Pathologically documented epithelial cancers of ovarian, fallopian tube, or peritoneal origin
    • Unresectable locally-advanced or metastatic stage disease
    • Prior therapies
  • Cohort 4: Endometrial Cancer
    • Must have pathologically documented adenocarcinoma of the endometrium
    • Must have unresectable locally-advanced or metastatic stage disease.
    • Prior therapies
  • 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

    • Key dates

    Study start date
    • November 2023
    Estimated primary completion date
    • May 2028

    Key endpoints

    Primary Outcome Measures
    Outcome Measure

    Confirmed Objective Response Rate (ORR) per Response Evaluation in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment

    Measure Description

    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

    Time Frame

    Approximately 3 years

    Primary Outcome Measures table for Clinical Trial
    Secondary Outcome Measures:
    Outcome Measure

    Number of participants with adverse events (AEs)

    Measure Description

    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

    Time Frame

    Through 30-37 days after the last dose of DV; approximately 5 years

    Outcome Measure

    Number of participants with laboratories abnormalities

    Measure Description

    Time Frame

    Through 30-37 days after the last dose of DV; approximately 5 years

    Outcome Measure

    Number of participants with dose alterations due to AEs

    Measure Description

    Time Frame

    Approximately 5 years

    Outcome Measure

    Confirmed Disease Control Rate (DCR) per RECIST v1.1 by investigator assessment

    Measure Description

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

    Time Frame

    Approximately 5 years

    Outcome Measure

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

    Measure Description

    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

    Time Frame

    Approximately 5 years

    Outcome Measure

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

    Measure Description

    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

    Time Frame

    Approximately 5 years

    Outcome Measure

    Overall Survival (OS)

    Measure Description

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

    Time Frame

    Approximately 5 years

    Outcome Measure

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

    Measure Description

    Analyzed through cycle 2.

    Time Frame

    Approximately 1 month

    Outcome Measure

    PK parameter - Maximum concentration (Cmax)

    Measure Description

    Analyzed through end of treatment.

    Time Frame

    Through 30-37 days after the last dose of DV; approximately 5 years

    Outcome Measure

    PK parameter - Trough concentration (Ctrough)

    Measure Description

    Analyzed through end of treatment.

    Time Frame

    Through 30-37 days after the last dose of DV; approximately 5 years

    Outcome Measure

    Incidence of antidrug antibodies (ADAs)

    Measure Description

    Time Frame

    Through 30-37 days after the last dose of DV; approximately 5 years

    Secondary Outcome Measures table for Clinical Trial

    Number of participants

    160

    Collaborators and investigators

    Sponsor: Seagen Inc.

    Collaborator: None

    This information is current as of September 4th 2024.
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    When calling, please reference this study number:

    More Information Close NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier. NCT06003231