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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06003231




Registration number
NCT06003231
Ethics application status
Date submitted
15/08/2023
Date registered
21/08/2023

Titles & IDs
Public title
A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2
Scientific 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
Secondary ID [1] 0 0
SGNDV-005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Squamous Cell of Head and Neck 0 0
Carcinoma, Non-Small-Cell Lung 0 0
Ovarian Neoplasms 0 0
Endometrial Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - disitamab vedotin

Experimental: Disitamab vedotin monotherapy - Disitamab vedotin monotherapy


Treatment: Drugs: disitamab vedotin
Given into the vein (IV, intravenous) every 2 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Confirmed Objective Response Rate (ORR) per Response Evaluation in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment
Timepoint [1] 0 0
Approximately 3 years
Secondary outcome [1] 0 0
Number of participants with adverse events (AEs)
Timepoint [1] 0 0
Through 30-37 days after the last dose of DV; approximately 5 years
Secondary outcome [2] 0 0
Number of participants with laboratories abnormalities
Timepoint [2] 0 0
Through 30-37 days after the last dose of DV; approximately 5 years
Secondary outcome [3] 0 0
Number of participants with dose alterations due to AEs
Timepoint [3] 0 0
Approximately 5 years
Secondary outcome [4] 0 0
Confirmed Disease Control Rate (DCR) per RECIST v1.1 by investigator assessment
Timepoint [4] 0 0
Approximately 5 years
Secondary outcome [5] 0 0
Duration of Response (DOR) per RECIST v1.1 by investigator assessment
Timepoint [5] 0 0
Approximately 5 years
Secondary outcome [6] 0 0
Progression free survival (PFS) per RECIST v1.1 by investigator assessment
Timepoint [6] 0 0
Approximately 5 years
Secondary outcome [7] 0 0
Overall Survival (OS)
Timepoint [7] 0 0
Approximately 5 years
Secondary outcome [8] 0 0
Pharmacokinetic (PK) parameter - Area under the concentration-time curve to the time of the last quantifiable concentration (AUClast)
Timepoint [8] 0 0
Approximately 1 month
Secondary outcome [9] 0 0
PK parameter - Maximum concentration (Cmax)
Timepoint [9] 0 0
Through 30-37 days after the last dose of DV; approximately 5 years
Secondary outcome [10] 0 0
PK parameter - Trough concentration (Ctrough)
Timepoint [10] 0 0
Through 30-37 days after the last dose of DV; approximately 5 years
Secondary outcome [11] 0 0
Incidence of antidrug antibodies (ADAs)
Timepoint [11] 0 0
Through 30-37 days after the last dose of DV; approximately 5 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/05/2028
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Othe
Recruitment hospital [1] 0 0
Blacktown Hospital - Blacktown NSW
Recruitment hospital [2] 0 0
Macquarie University Hospital - Brisbane
Recruitment hospital [3] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [4] 0 0
Peninsula and South East Oncology - Frankston
Recruitment postcode(s) [1] 0 0
2148 - Blacktown NSW
Recruitment postcode(s) [2] 0 0
2109 - Brisbane
Recruitment postcode(s) [3] 0 0
2050 - Camperdown
Recruitment postcode(s) [4] 0 0
3199 - Frankston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Montana
Country [11] 0 0
United States of America
State/province [11] 0 0
New Mexico
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oregon
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
Italy
State/province [20] 0 0
Other
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Other
Country [22] 0 0
Spain
State/province [22] 0 0
Other
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Other

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Seagen Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Seagen Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Seagen Trial Information Support
Address 0 0
Country 0 0
Phone 0 0
866-333-7436
Fax 0 0
Email 0 0
clinicaltrials@seagen.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06003231