Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Date last updated
18/06/2024

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
NA
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
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
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

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

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06003231
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06003231