A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2
- Conditions
- Interventions
- Registration Number
- NCT06003231
- Lead Sponsor
- Seagen Inc.
- 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...
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 160
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Cohort 1: Head and neck squamous cell carcinoma (HNSCC)
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Pathologically-documented squamous cell carcinoma of the head and neck with primary tumor site arising from the oral cavity, oropharynx, hypopharynx, and larynx
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Unresectable locally recurrent or metastatic stage disease
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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
-
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Cohort 2: Non-small cell lung cancer (NSCLC)
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Pathologically documented NSCLC
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Unresectable locally-advanced or metastatic stage disease
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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
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Cohort 3: Ovarian Cancer
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Pathologically documented epithelial cancers of ovarian, fallopian tube, or peritoneal origin
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Unresectable locally-advanced or metastatic stage disease
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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
-
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Cohort 4: Endometrial Cancer
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Must have pathologically documented adenocarcinoma of the endometrium
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Must have unresectable locally-advanced or metastatic stage disease.
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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
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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.
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Measurable disease per RECIST v1.1 criteria as assessed by the investigator
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Able to provide formalin-fixed, paraffin-embedded (FFPE) tumor tissue blocks (or freshly sectioned slides)
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Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Disitamab vedotin monotherapy disitamab vedotin Disitamab vedotin monotherapy
- Primary Outcome Measures
Name Time Method Confirmed Objective Response Rate (ORR) per Response Evaluation in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment 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
Name Time Method Number of participants with laboratories abnormalities Through 30-37 days after the last dose of DV; approximately 5 years Overall Survival (OS) Approximately 5 years The time from the start of study treatment to the date of death due to any cause
Number of participants with adverse events (AEs) 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
PK parameter - Maximum concentration (Cmax) Through 30-37 days after the last dose of DV; approximately 5 years Analyzed through end of treatment.
Incidence of antidrug antibodies (ADAs) Through 30-37 days after the last dose of DV; approximately 5 years Number of participants with dose alterations due to AEs Approximately 5 years Confirmed Disease Control Rate (DCR) per RECIST v1.1 by investigator assessment Approximately 5 years The proportion of participants with stable disease (SD) or confirmed CR or PR according to RECIST v1.1
PK parameter - Trough concentration (Ctrough) Through 30-37 days after the last dose of DV; approximately 5 years Analyzed through end of treatment.
Duration of Response (DOR) per RECIST v1.1 by investigator assessment 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
Pharmacokinetic (PK) parameter - Area under the concentration-time curve to the time of the last quantifiable concentration (AUClast) Approximately 1 month Analyzed through cycle 2.
Progression free survival (PFS) per RECIST v1.1 by investigator assessment 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
Trial Locations
- Locations (45)
Fondazione IRCCS San Gerardo dei Tintori
🇮🇹Monza, Other, Italy
Guy's and St Thomas' NHS Foundation
🇬🇧London, Other, United Kingdom
Ironwood Cancer & Research Centers - Chandler
🇺🇸Chandler, Arizona, United States
Valkyrie Clinical Trials
🇺🇸Los Angeles, California, United States
University of California Davis
🇺🇸Sacramento, California, United States
Providence Medical Foundation
🇺🇸Santa Rosa, California, United States
Colorado West Healthcare, dba Grand Valley Oncology
🇺🇸Grand Junction, Colorado, United States
Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
Eastern CT Hematology and Oncology Associates
🇺🇸Norwich, Connecticut, United States
University of Miami
🇺🇸Miami, Florida, United States
Augusta University
🇺🇸Augusta, Georgia, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Karmanos Cancer Institute / Wayne State University
🇺🇸Detroit, Michigan, United States
HealthPartners Institute
🇺🇸Saint Louis Park, Minnesota, United States
St. Vincent Frontier Cancer Center
🇺🇸Billings, Montana, United States
Optimum Clinical Research Group, LLC (Southwest Women's Oncology)
🇺🇸Albuquerque, New Mexico, United States
NYU Langone Hospital
🇺🇸New York, New York, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Ruttenberg Treatment Center, Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Gabrail Cancer Center Research
🇺🇸Canton, Ohio, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Renovatio Clinical
🇺🇸The Woodlands, Texas, United States
MD Anderson Cancer Center / University of Texas
🇺🇸Houston, Texas, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Fred Hutchinson Cancer Research Center | Seattle, WA
🇺🇸Seattle, Washington, United States
Blacktown Hospital
🇦🇺Blacktown NSW, Other, Australia
Macquarie University Hospital
🇦🇺Brisbane, Other, Australia
Chris O'Brien Lifehouse
🇦🇺Camperdown, Other, Australia
Peninsula and South East Oncology
🇦🇺Frankston, Other, Australia
University Health Network, Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
McGill University Department of Oncology / McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
CHU de Quebec-Universite Laval
🇨🇦Quebec, Canada
Chungbuk National University Hospital
🇰🇷Cheongju-si, Other, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Other, Korea, Republic of
CHA Bundang Medical Center
🇰🇷Seongnam, Other, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Other, Korea, Republic of
Sungkyunkwan University of Medicine - Samsung Changwon Hospital
🇰🇷Seoul, Other, Korea, Republic of
Hospital del Mar
🇪🇸Barcelona, Other, Spain
Hospital Universitario Reina Sofia
🇪🇸Cordoba, Other, Spain
Clinica Universidad de Navarra
🇪🇸Pamplona, Other, Spain
University College London Hospitals NHS Foundation Trust
🇬🇧London, Other, United Kingdom
The Royal Marsden NHS Foundation Trust (RM)
🇬🇧London, Other, United Kingdom
Royal Marsden Hospital Sutton
🇬🇧Sutton, Other, United Kingdom