A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors
NCT ID: NCT06157892
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
172 participants
INTERVENTIONAL
2024-05-20
2029-07-28
Brief Summary
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Participants in this study must have breast cancer or gastric cancer. Participants must have tumors that have HER2 on them. This allows the cancer to grow more quickly or spread faster. There are few treatment options for patients with advanced or metastatic solid tumors that express HER2.
This clinical trial uses an experimental drug called disitamab vedotin (DV). Disitamab vedotin is a type of antibody drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them.
This clinical trial uses a drug called tucatinib, which has been approved to treat cancer in the United States and some other countries. This drug is sold under the brand name TUKYSA®.
This study will test how safe and how well DV with tucatinib works for participants with solid tumors. This study will also test what side effects happen when participants take these drugs. A side effect is anything a drug does to the body besides treating the disease.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation - Previously treated advanced GC/GEJC or breast cancer
disitamab vedotin + tucatinib
disitamab vedotin
Given into the vein (IV; intravenous)
tucatinib
300mg given twice daily by mouth (orally)
Dose Optimization - HER2-low and HER2+ LA/mBC
disitamab vedotin + tucatinib
disitamab vedotin
Given into the vein (IV; intravenous)
tucatinib
300mg given twice daily by mouth (orally)
Dose Optimization - HER2-low and HER2+ LA/mGC/GEJC
disitamab vedotin + tucatinib
disitamab vedotin
Given into the vein (IV; intravenous)
tucatinib
300mg given twice daily by mouth (orally)
Dose Expansion - HER2-low LA/mBC
disitamab vedotin + tucatinib
disitamab vedotin
Given into the vein (IV; intravenous)
tucatinib
300mg given twice daily by mouth (orally)
Dose Expansion - HER2+ LA/mBC
disitamab vedotin + tucatinib
disitamab vedotin
Given into the vein (IV; intravenous)
tucatinib
300mg given twice daily by mouth (orally)
Dose Expansion - HER2-low LA/mGC/GEJC
disitamab vedotin + tucatinib
disitamab vedotin
Given into the vein (IV; intravenous)
tucatinib
300mg given twice daily by mouth (orally)
Dose Expansion - HER2+ LA/mGC/GEJC
disitamab vedotin + tucatinib
disitamab vedotin
Given into the vein (IV; intravenous)
tucatinib
300mg given twice daily by mouth (orally)
Interventions
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disitamab vedotin
Given into the vein (IV; intravenous)
tucatinib
300mg given twice daily by mouth (orally)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
* Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma or breast carcinoma
* Locally-advanced, unresectable, or metastatic stage
* Must have experienced disease progression on or after standard of care therapies or be intolerant of standard of care therapies.
* Histologically or cytologically confirmed diagnosis of breast carcinoma
* Locally-advanced, unresectable, or metastatic stage
* HER2-low status determined by most recent local assessment (IHC 1+ or IHC 2+/ISH-negative)
* Prior therapies requirements
* No more than 3 prior systemic cytotoxic chemotherapy regimens (including ADCs) for LA/mBC.
* Participants with known BRCA mutation must have received a PARP-inhibitor where available and not medically contraindicated
* Have progression on or after, or intolerant to, T-DXd, sacituzumab govitecan, or other topoisomerase I inhibitor therapies, if available as local standard of care therapy
* Participants with HR+ tumors must have intolerance to endocrine therapy or endocrine therapy refractory disease:
* Progressed on ≥2 lines of endocrine therapy for LA/mBC AND had received a CDK4/6 inhibitor in the adjuvant or metastatic setting OR
* Progressed on 1 line of endocrine therapy for LA/mBC AND had a relapse while on adjuvant endocrine therapy after definitive surgery for primary tumor AND had received a CDK4/6 inhibitor in the adjuvant or advanced setting
* Participants with HR negative, HER2-low and PD-L1-positive (CPS 10 or greater) tumors must have received pembrolizumab with chemotherapy if available as local standard of care therapy.
* Participants with HR negative, HER2-low and PD-L1-positive (CPS 10 or greater) tumors must have received pembrolizumab (or other PD-(L)1 inhibitor) with chemotherapy if available as local standard of care therapy and not medically contraindicated.
* Histologically or cytologically confirmed diagnosis breast carcinoma
* Locally-advanced, unresectable, or metastatic stage
* HER2+ status determined by most recent local assessment (IHC 3+ or IHC 2+/ISH+)
* Participants must have:
* Received prior trastuzumab, pertuzumab and a taxane if available as local standard of care therapy for advanced disease.
* Have progression on or after, or intolerant to, T-DXd or other topoisomerase I inhibitor therapies
* No more than 3 prior systemic cytotoxic chemotherapy regimens (including ADCs) for LA/mBC
* Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma
* Locally-advanced, unresectable, or metastatic stage
* HER2-low expression defined as IHC 1+ or IHC 2+/ISH-negative determined by most recent local assessment
* Willing and able to provide archival or newly obtained formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks
* Participants must have received:
* Prior systemic therapy with platinum, fluorouracil, or taxane for locally advanced unresectable or metastatic disease
* Progression within 6 months of last dose of (neo)adjuvant cytotoxic chemotherapy is considered as 1 line of systemic therapy for LA/mGC/GEJC
* Prior anti-PD-(L)1 therapy is allowed
* No more than 2 prior systemic cytotoxic chemotherapy regimens (including ADC) for LA/mGC/GEJC
* Must not have received prior treatment with HER2 directed therapy
* Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma
* Locally-advanced, unresectable, or metastatic stage
* HER2+ status determined by most recent local assessment (IHC 3+ or IHC 2+/ISH+)
* Participants must have:
* Received prior trastuzumab plus fluoropyrimidine and platinum containing chemotherapy if no contraindication.
* Prior T-DXd treatment is allowed
* Prior PD1 inhibitor therapy is allowed
* No more than 2 prior systemic cytotoxic chemotherapy regimens (including ADCs) for LA/mGC/GEJC
Exclusion Criteria
* Prior therapy with ADCs with MMAE payload
* Prior therapy with tucatinib
* Active CNS and/or leptomeningeal metastasis.
* Participants who have received prior systemic anticancer treatment including investigational agents within 4 weeks prior to first dose of study treatment
* History of other invasive malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.
* Unable to swallow oral tablets or capsules or any significant GI disease which would preclude the adequate oral absorption of medications
18 Years
ALL
No
Sponsors
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RemeGen Co., Ltd.
INDUSTRY
Seagen, a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Banner-University Medical Center Tucson Campus
Tucson, Arizona, United States
Banner-University Medical Center Tucson Campus
Tucson, Arizona, United States
The University of Arizona Cancer Center-North Campus Pharmacy, Attn: Kelly Myrdal
Tucson, Arizona, United States
University of Arizona Cancer Center - North Campus
Tucson, Arizona, United States
The University of Arizona Cancer Center-Main
Tucson, Arizona, United States
UC Irvine Health - Chao Family Comprehensive Cancer Center
Orange, California, United States
UC Irvine Medical Center
Orange, California, United States
University of California, San Francisco | HDFCCC - Hematopoietic Malignancies
San Francisco, California, United States
UCLA Department of Medicine - Hematology & Oncology
Santa Monica, California, United States
UCLA Hematology/Oncology - Parkside
Santa Monica, California, United States
Colorado West Healthcare System, dba Community Hospital
Grand Junction, Colorado, United States
Colorado West Healthcare, dba Grand Valley Oncology
Grand Junction, Colorado, United States
Danbury Hospital
Danbury, Connecticut, United States
The Whittingham Cancer Center / Norwalk Hospital
Norwalk, Connecticut, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Moffitt Cancer Center - International Plaza
Tampa, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, United States
Moffitt McKinley Hospital
Tampa, Florida, United States
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida, United States
Georgia Cancer Specialists - Athens
Athens, Georgia, United States
Georgia Cancer Specialists - Annex
Atlanta, Georgia, United States
Atlanta Cancer Care - Atlanta
Atlanta, Georgia, United States
Georgia Cancer Specialists-Northside
Atlanta, Georgia, United States
Northside Hospital, Inc.- Central Research Department
Atlanta, Georgia, United States
Northside Hospital
Atlanta, Georgia, United States
Georgia Cancer Specialists - Blairsville
Blairsville, Georgia, United States
Georgia Cancer Specialists - Canton
Canton, Georgia, United States
Atlanta Cancer Care - Cumming
Cumming, Georgia, United States
Georgia Cancer Specialists - Cumming
Cumming, Georgia, United States
Georgia Cancer Specialists - Decatur
Decatur, Georgia, United States
Suburban Hematology-Oncology Associates - Duluth
Duluth, Georgia, United States
Suburban Hematology-Oncology Associates- Lawrenceville
Lawrenceville, Georgia, United States
Georgia Cancer Specialists - Macon
Macon, Georgia, United States
Georgia Cancer Specialists - Marietta
Marietta, Georgia, United States
Memorial Hospital
Shiloh, Illinois, United States
Siteman Cancer Center - Shiloh
Shiloh, Illinois, United States
Massachusetts General Hospital.
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Dana Farber Cancer Institute- Chestnut Hill
Newton, Massachusetts, United States
Siteman Cancer Center - St Peters
City of Saint Peters, Missouri, United States
Siteman Cancer Center - West County
Creve Coeur, Missouri, United States
Siteman Cancer Center - North County
Florissant, Missouri, United States
Saint Luke's Cancer Institute LLC
Kansas City, Missouri, United States
Saint Luke's Hospital Investigational Pharmacy
Kansas City, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Siteman Cancer Center - South County
St Louis, Missouri, United States
Renown Regional Medical Center
Reno, Nevada, United States
MSK Basking Ridge
Basking Ridge, New Jersey, United States
MSK Monmouth.
Middletown, New Jersey, United States
MSK Bergen.
Montvale, New Jersey, United States
San Juan Oncology Associates
Farmington, New Mexico, United States
MSK Commack.
Commack, New York, United States
MSK Westchester.
Harrison, New York, United States
Investigational Drug Service
Long Island City, New York, United States
Memorial Sloan Kettering Cancer Center - Main Hospital
New York, New York, United States
MSK Nassau.
Uniondale, New York, United States
Zangmeister Cancer Center
Columbus, Ohio, United States
Saint Francis Hospital / Bon Secours - South Carolina
Greenville, South Carolina, United States
Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Tennessee Oncology-Nashville/Sarah Cannon Research Institute
Nashville, Tennessee, United States
Parkland Health and Hospital System
Dallas, Texas, United States
University of Texas Southwestern Medical Center - Simmons Cancer Center
Dallas, Texas, United States
University of Texas Southwestern Medical Center-Simmons Cancer Center Pharmacy
Dallas, Texas, United States
University of Texas Southwestern Medical Center Simmons Cancer Center - Redbird
Dallas, Texas, United States
University of Texas Southwestern Medical Center Clinical Lab-Zale Lipshy University Hospital
Dallas, Texas, United States
University of Texas Southwestern Medical Center-William P. Clements Jr. University Hospital
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
National Taiwan University Cancer Center
Taipei, , Taiwan
University of Texas Southwestern Simmons Cancer Center - Fort Worth
Fort Worth, Texas, United States
University of Texas Southwestern Medical Center Simmons Cancer Center - Richardson/Plano
Richardson, Texas, United States
Harborview Medical Center
Seattle, Washington, United States
Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, United States
Carbone Cancer Center / University of Wisconsin
Madison, Wisconsin, United States
Peninsula & South Eastern Hematology and Oncology Group (PASO)
Frankston, Victoria, Australia
Slade Pharmacy Frankston
Frankston, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Slade Health
Mount Waverley, Victoria, Australia
Peninsula & South Eastern Hematology and Oncology Group (PASO)
Frankston, , Australia
Peter MacCallum Cancer Centre
Melbourne, , Australia
BC Cancer Kelowna.
Kelowna, British Columbia, Canada
Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
University Health Network - Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Charité Universitätsmedizin Berlin, Campus Benjamin Franklin (CBF)
Berlin, , Germany
Universitatsklinikum Essen
Essen, , Germany
Heidelberg University Hospital and German Cancer Research Center
Heidelberg, , Germany
Klinikums rechts der Isar der TU München
München, , Germany
A.O.U. Federico II
Napoli, Campania, Italy
Azienda Ospedaliera Universitaria (AOU) Federico II
Napoli, Campania, Italy
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale.
Napoli, Campania, Italy
Istituto Europeo di Oncologia
Milan, Lombardy, Italy
Niguarda Ca' Granda Hospital
Milan, Lombardy, Italy
Humanitas Istituto Clinico Catanese
Misterbianco (CT), Sicily, Italy
Azienda Ospedaliera Universitaria Integrata di Verona.
Verona, Veneto, Italy
A.O.U. Federico II- U.O.C. Diagnostica per lmmagini e Radioterapia
Napoli, , Italy
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Dong-A University Hospital
Busan, Other, South Korea
National Cancer Center
Goyang-si, Other, South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Chungbuk National University Hospital
Cheongju-si, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
St. Vincent's Hospital, The Catholic University of Korea
Suwon, , South Korea
Quirén Salud Barcelona
Barcelona, , Spain
Hospital Universitari Vall d´Hebron
Barcelona, , Spain
Institut Catala d'Oncologia
Barcelona, , Spain
CETIR Grup Medic
Barcelona, , Spain
Hospital Universitario de Basurto
Bilbao, , Spain
Grupo Hospitalario QuironSalud
Erandio Bizkaia, , Spain
Farmacia-Ensayos. Planta S - Hospital Universitario HM Sanchinarro-CIOCC-START Madrid
Madrid, , Spain
START Madrid-CIOCC_Hospital HM Sanchinarro
Madrid, , Spain
Ecg Medica Sl
Valencia, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
National Cheng Kung University Hospital
Tainan, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan, , Taiwan
Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
The Royal Marsden Hospital
Sutton, Surrey, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom
St Bartholomew's Hospital
London, , United Kingdom
The Royal Marsden Hospital
London, , United Kingdom
The Royal Marsden NHS Foundation Trust (RM)
London, , United Kingdom
The Royal Marsden NHS Foundation Trust
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, , United Kingdom
Countries
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Central Contacts
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C5731004
Identifier Type: OTHER
Identifier Source: secondary_id
2023-507555-29-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
SGNDV-004
Identifier Type: -
Identifier Source: org_study_id
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