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

Carcinoma, Non-Small-Cell Lung Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06003231
• Other study ID #: SGNDV-005
• Status: Recruiting
• Phase: Phase 2
• Start date: November 14, 2023
• Est. completion date: May 31, 2028

Study information

• Verified date: May 2024
• Source: Seagen Inc.
• Contact: Seagen Trial Information Support
• Phone: 866-333-7436
• Email: clinicaltrials[@]seagen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: May 31, 2028
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Squamous Cell
• Carcinoma, Squamous Cell of Head and Neck
• Endometrial Neoplasms
• Neoplasms
• Ovarian Neoplasms
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• disitamab vedotin
Given into the vein (IV, intravenous) every 2 weeks

Locations

Country	Name	City	State
Australia	Peninsula and South East Oncology	Frankston	Other
Canada	McGill University Department of Oncology / McGill University Health Centre	Montreal	Quebec
Canada	CHU de Quebec-Universite Laval	Quebec
Canada	University Health Network, Princess Margaret Hospital	Toronto	Ontario
United States	Optimum Clinical Research Group, LLC (Southwest Women's Oncology)	Albuquerque	New Mexico
United States	St. Vincent Frontier Cancer Center	Billings	Montana
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Gabrail Cancer Center Research, LLC	Canton	Ohio
United States	Ironwood Cancer & Research Centers - Chandler	Chandler	Arizona
United States	Karmanos Cancer Institute / Wayne State University	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Renovatio Clinical	El Paso	Texas
United States	Colorado West Healthcare, dba Grand Valley Oncology	Grand Junction	Colorado
United States	MD Anderson Cancer Center / University of Texas	Houston	Texas
United States	Valkyrie Clinical Trials	Los Angeles	California
United States	University of Miami	Miami	Florida
United States	NYU Langone Hospital	Mineola	New York
United States	Yale Cancer Center	New Haven	Connecticut
United States	NYU Langone Hospital	New York	New York
United States	Eastern CT Hematology and Oncology Associates	Norwich	Connecticut
United States	Providence Portland Medical Center	Portland	Oregon
United States	Providence Portland Medical Center	Portland	Oregon
United States	University of California Davis	Sacramento	California
United States	HealthPartners Institute	Saint Louis Park	Minnesota
United States	Providence Medical Foundation	Santa Rosa	California
United States	Fred Hutchinson Cancer Research Center | Seattle, WA	Seattle	Washington
United States	Renovatio Clinical	The Woodlands	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Seagen Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmed Objective Response Rate (ORR) per Response Evaluation in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment	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	Number of participants with adverse events (AEs)	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
Secondary	Number of participants with laboratories abnormalities		Through 30-37 days after the last dose of DV; approximately 5 years
Secondary	Number of participants with dose alterations due to AEs		Approximately 5 years
Secondary	Confirmed Disease Control Rate (DCR) per RECIST v1.1 by investigator assessment	The proportion of participants with stable disease (SD) or confirmed CR or PR according to RECIST v1.1	Approximately 5 years
Secondary	Duration of Response (DOR) per RECIST v1.1 by investigator assessment	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
Secondary	Progression free survival (PFS) per RECIST v1.1 by investigator assessment	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
Secondary	Overall Survival (OS)	The time from the start of study treatment to the date of death due to any cause	Approximately 5 years
Secondary	Pharmacokinetic (PK) parameter - Area under the concentration-time curve to the time of the last quantifiable concentration (AUClast)	Analyzed through cycle 2.	Approximately 1 month
Secondary	PK parameter - Maximum concentration (Cmax)	Analyzed through end of treatment.	Through 30-37 days after the last dose of DV; approximately 5 years
Secondary	PK parameter - Trough concentration (Ctrough)	Analyzed through end of treatment.	Through 30-37 days after the last dose of DV; approximately 5 years
Secondary	Incidence of antidrug antibodies (ADAs)		Through 30-37 days after the last dose of DV; approximately 5 years