A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors

May 4, 2026 updated by: Seagen, a wholly owned subsidiary of Pfizer

A Phase 1b/2 Open-Label Study of Disitamab Vedotin in Combination With Other Anticancer Therapies in Solid Tumors

This clinical trial is studying solid tumor cancers. A solid tumor is one that starts in part of your body like your lungs or liver instead of your blood. Once they've grown bigger in one spot or spread to other parts of the body, they're harder to treat. This is called advanced or metastatic cancer.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This clinical trial is to evaluate disitamab vedotin in combination with tucatinib in subjects with LA/metastatic breast cancer or gastric cancer/GEJC that express HER2. The study has a dose escalation phase evaluating disitamab vedotin plus tucatinib followed by a dose optimization phase. The 2 dose levels identified in the dose escalation phase will be assessed in the optimization phase for both safety and efficacy in HER2-expressing LA/mBC and LA/mGC/GEJC. Once the safety and efficacy profile of disitamab vedotin plus tucatinib has been established and a disitamab vedotin dose with the optimum benefit/risk ratio has been determined the disitamab vedotin plus tucatinib combination therapy will be evaluated in an expansion phase with 4 expansion cohorts in subjects with HER2-low LA/mGC/GEJC, HER2+ LA/mGC/GEJC, HER2-low LA/mBC, and HER2+ LA/mBC.

Study Type

Interventional

Enrollment (Estimated)

172

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Pfizer CT.gov Call Center
Phone Number: 1-800-718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

Australia
- - Melbourne, Australia, 3000
    - Not yet recruiting
    - Peter MacCallum Cancer Centre
- Victoria
  - Frankston, Victoria, Australia, 3199
    - Not yet recruiting
    - Peninsula & South Eastern Hematology and Oncology Group (PASO)
  - Frankston, Victoria, Australia, 3199
    - Not yet recruiting
    - Slade Pharmacy Frankston
  - Frankston, Victoria, Australia
    - Not yet recruiting
    - Peninsula & South Eastern Hematology and Oncology Group (PASO)
  - Mount Waverley, Victoria, Australia, 3149
    - Not yet recruiting
    - Slade Health
Canada
- British Columbia
  - Kelowna, British Columbia, Canada, V1Y 5L3
    - Recruiting
    - BC Cancer Kelowna.
- Ontario
  - Ottawa, Ontario, Canada, K1H 8L6
    - Recruiting
    - Ottawa Hospital Cancer Centre
    - Principal Investigator:
      
      Arif Ali Awan
  - Toronto, Ontario, Canada, M4N 3M5
    - Recruiting
    - Sunnybrook Health Sciences Centre
    - Principal Investigator:
      
      Rossanna Pezo
  - Toronto, Ontario, Canada, M5G 2M9
    - Recruiting
    - University Health Network - Princess Margaret Cancer Centre
Germany
- - Berlin, Germany, 12203
    - Recruiting
    - Charité Universitätsmedizin Berlin, Campus Benjamin Franklin (CBF)
  - Essen, Germany, 45147
    - Recruiting
    - Universitatsklinikum Essen
  - Heidelberg, Germany, 69120
    - Recruiting
    - Heidelberg University Hospital and German Cancer Research Center
Italy
- - Milan, Italy, 20162
    - Recruiting
    - Niguarda Ca' Granda Hospital
  - Naples, Italy, 80131
    - Recruiting
    - A.O.U. Federico II- U.O.C. Diagnostica per lmmagini e Radioterapia
- Campania
  - Naples, Campania, Italy, 80131
    - Recruiting
    - A.O.U. Federico II
  - Naples, Campania, Italy, 80131
    - Recruiting
    - Azienda Ospedaliera Universitaria (AOU) Federico II
  - Naples, Campania, Italy, 80131
    - Recruiting
    - Istituto Nazionale Tumori IRCCS Fondazione G. Pascale.
- Lombardy
  - Milan, Lombardy, Italy, 20141
    - Recruiting
    - Istituto Europeo di Oncologia
- Sicily
  - Misterbianco (CT), Sicily, Italy, 95045
    - Recruiting
    - Humanitas Istituto Clinico Catanese
- Veneto
  - Verona, Veneto, Italy, 37134
    - Recruiting
    - Azienda Ospedaliera Universitaria Integrata di Verona.
Japan
- - Okayama, Japan, 700-8558
    - Not yet recruiting
    - Okayama University Hospital
  - Tokyo, Japan, 142-8666
    - Not yet recruiting
    - Showa Medical University Hospital
- Tokyo
  - Koto-ku, Tokyo, Japan, 135-8550
    - Not yet recruiting
    - Cancer Institute Hospital of Jfcr
  - Koto-ku, Tokyo, Japan, 135-8550
    - Not yet recruiting
    - Japanese Foundation for Cancer Research
- Tokyo-to
  - Shinagawa-ku, Tokyo-to, Japan, 142-8666
    - Not yet recruiting
    - Showa University Hospital
South Korea
- - Cheongju-si, South Korea, 28644
    - Not yet recruiting
    - Chungbuk National University Hospital
  - Incheon, South Korea, 21565
    - Not yet recruiting
    - Gachon University Gil Medical Center
  - Seoul, South Korea, 02841
    - Recruiting
    - Korea University Anam Hospital
  - Seoul, South Korea, 03722
    - Recruiting
    - Severance Hospital Yonsei University Health System
  - Suwon, South Korea, 16247
    - Not yet recruiting
    - St. Vincent's Hospital, The Catholic University of Korea
- Gyeonggi-do
  - Seongnam-si, Gyeonggi-do, South Korea, 13620
    - Recruiting
    - Seoul National University Bundang Hospital
- Other
  - Busan, Other, South Korea, 49201
    - Not yet recruiting
    - Dong-A University Hospital
  - Goyang-si, Other, South Korea, 10408
    - Recruiting
    - National Cancer Center
- Seoul-teukbyeolsi [seoul]
  - Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03080
    - Recruiting
    - Seoul National University Hospital
Spain
- - Barcelona, Spain, 08035
    - Recruiting
    - Hospital Universitari Vall d´Hebrón
  - Barcelona, Spain, 08908
    - Recruiting
    - Institut Catala d'Oncologia
  - Barcelona, Spain, 08950
    - Recruiting
    - CETIR Grup Medic
  - Barcelona, Spain, 08023
    - Recruiting
    - Quirén Salud Barcelona
  - Bilbao, Spain, 48013
    - Recruiting
    - Hospital Universitario de Basurto
  - Erandio Bizkaia, Spain, 48950
    - Recruiting
    - Grupo Hospitalario QuironSalud
  - Madrid, Spain, 28050
    - Recruiting
    - Farmacia-Ensayos. Planta S - Hospital Universitario HM Sanchinarro-CIOCC-START Madrid
  - Madrid, Spain, 28050
    - Recruiting
    - START Madrid-CIOCC_Hospital HM Sanchinarro
  - Valencia, Spain, 46010
    - Recruiting
    - Hospital Clínico Universitario de Valencia
  - Valencia, Spain, 46004
    - Recruiting
    - Ecg Medica Sl
Taiwan
- - Tainan, Taiwan, 704
    - Not yet recruiting
    - National Cheng Kung University Hospital
  - Tainan, Taiwan, 704017
    - Not yet recruiting
    - National Cheng Kung University Hospital
  - Taipei, Taiwan, 100
    - Not yet recruiting
    - National Taiwan University Hospital
  - Taipei, Taiwan, 100225
    - Not yet recruiting
    - National Taiwan University Hospital
  - Taipei, Taiwan, 106
    - Not yet recruiting
    - National Taiwan University Cancer Center
  - Taoyuan, Taiwan, 333
    - Not yet recruiting
    - Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
  - Taoyuan City, Taiwan, 333
    - Not yet recruiting
    - Linkou Chang Gung Memorial Hospital
United Kingdom
- - London, United Kingdom, SW3 6JJ
    - Recruiting
    - The Royal Marsden Hospital
  - London, United Kingdom, SW3 6JJ
    - Recruiting
    - The Royal Marsden NHS Foundation Trust
  - London, United Kingdom, EC1M 6BQ
    - Not yet recruiting
    - St Bartholomew's Hospital
  - London, United Kingdom, SW3 6JJ
    - Recruiting
    - The Royal Marsden NHS Foundation Trust (RM)
  - Manchester, United Kingdom, M20 4GJ
    - Not yet recruiting
    - The Christie Nhs Foundation Trust
  - Sutton, United Kingdom, SM2 5PT
    - Recruiting
    - The Royal Marsden NHS Foundation Trust
- Surrey
  - Sutton, Surrey, United Kingdom, SM2 5PT
    - Recruiting
    - The Royal Marsden NHS Foundation Trust
  - Sutton, Surrey, United Kingdom, SM2 5PT
    - Recruiting
    - The Royal Marsden Hospital
United States
- Arizona
  - Tucson, Arizona, United States, 85719
    - Recruiting
    - University of Arizona Cancer Center - North Campus
  - Tucson, Arizona, United States, 85719
    - Recruiting
    - Banner-University Medical Center Tucson Campus
  - Tucson, Arizona, United States, 85719
    - Recruiting
    - The University of Arizona Cancer Center-North Campus Pharmacy, Attn: Kelly Myrdal
  - Tucson, Arizona, United States, 85724
    - Recruiting
    - The University of Arizona Cancer Center-Main
  - Tucson, Arizona, United States, 85704
    - Recruiting
    - Banner-University Medical Center Tucson Campus
- California
  - Orange, California, United States, 92868
    - Recruiting
    - UC Irvine Medical Center
  - Orange, California, United States, 92868
    - Recruiting
    - UC Irvine Health - Chao Family Comprehensive Cancer Center
  - San Francisco, California, United States, 94158
    - Recruiting
    - University of California, San Francisco | HDFCCC - Hematopoietic Malignancies
    - Contact:
      
      Amy Deluca
      
      Phone Number: 415-353-7288
      
      Email: amy.deluca@ucsf.edu
    - Principal Investigator:
      
      Amy Jo Chien
  - Santa Monica, California, United States, 90404
    - Recruiting
    - UCLA Hematology/Oncology - Parkside
  - Santa Monica, California, United States, 90404
    - Recruiting
    - UCLA Department of Medicine - Hematology & Oncology
    - Principal Investigator:
      
      Zev Wainberg
    - Contact:
      
      Jenna Davis
      
      Phone Number: 310-633-8400 x16128
      
      Email: JLdavis@mednet.ucla.edu
- Colorado
  - Grand Junction, Colorado, United States, 81505
    - Not yet recruiting
    - Colorado West Healthcare System, dba Community Hospital
  - Grand Junction, Colorado, United States, 81505
    - Not yet recruiting
    - Colorado West Healthcare, dba Grand Valley Oncology
- Connecticut
  - Danbury, Connecticut, United States, 06810
    - Not yet recruiting
    - Danbury Hospital
  - Danbury, Connecticut, United States, 06810
    - Recruiting
    - Praxair Cancer Center / Danbury Hospital
    - Contact:
      
      Pramila Krumholtz
      
      Phone Number: 203-852-2996
      
      Email: Pramila.Krumholtz@wchn.org
    - Principal Investigator:
      
      George F Zahrah
  - Norwalk, Connecticut, United States, 06856
    - Not yet recruiting
    - The Whittingham Cancer Center / Norwalk Hospital
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20007
    - Recruiting
    - MedStar Georgetown University Hospital
  - Washington D.C., District of Columbia, United States, 20007
    - Recruiting
    - Georgetown University Medical Center
- Florida
  - Tampa, Florida, United States, 33612
    - Recruiting
    - Moffitt Cancer Center - McKinley Campus
  - Tampa, Florida, United States, 33612
    - Recruiting
    - H. Lee Moffitt Cancer Center and Research Institute
  - Tampa, Florida, United States, 33612
    - Recruiting
    - Moffitt McKinley Hospital
  - Tampa, Florida, United States, 33607
    - Recruiting
    - Moffitt Cancer Center - International Plaza
  - Wesley Chapel, Florida, United States, 33544
    - Recruiting
    - Moffitt Cancer Center at Wesley Chapel
- Georgia
  - Athens, Georgia, United States, 30606
    - Recruiting
    - Georgia Cancer Specialists - Athens
  - Atlanta, Georgia, United States, 30342
    - Recruiting
    - Northside Hospital
  - Atlanta, Georgia, United States, 30341
    - Recruiting
    - Georgia Cancer Specialists - Annex
  - Atlanta, Georgia, United States, 30342
    - Recruiting
    - Atlanta Cancer Care - Atlanta
  - Atlanta, Georgia, United States, 30342
    - Recruiting
    - Georgia Cancer Specialists-Northside
  - Atlanta, Georgia, United States, 30342
    - Recruiting
    - Northside Hospital, Inc.- Central Research Department
  - Blairsville, Georgia, United States, 30512
    - Recruiting
    - Georgia Cancer Specialists - Blairsville
  - Canton, Georgia, United States, 30115
    - Recruiting
    - Georgia Cancer Specialists - Canton
  - Cumming, Georgia, United States, 30041
    - Recruiting
    - Atlanta Cancer Care - Cumming
  - Cumming, Georgia, United States, 30041
    - Recruiting
    - Georgia Cancer Specialists - Cumming
  - Decatur, Georgia, United States, 30033
    - Recruiting
    - Georgia Cancer Specialists - Decatur
  - Duluth, Georgia, United States, 30096
    - Recruiting
    - Suburban Hematology-Oncology Associates - Duluth
  - Lawrenceville, Georgia, United States, 30046
    - Recruiting
    - Suburban Hematology-Oncology Associates- Lawrenceville
  - Macon, Georgia, United States, 31217
    - Recruiting
    - Georgia Cancer Specialists - Macon
  - Marietta, Georgia, United States, 30060
    - Recruiting
    - Georgia Cancer Specialists - Marietta
- Illinois
  - Shiloh, Illinois, United States, 62269
    - Recruiting
    - Siteman Cancer Center - Shiloh
  - Shiloh, Illinois, United States, 62269
    - Recruiting
    - Memorial Hospital
- Massachusetts
  - Boston, Massachusetts, United States, 02115
    - Recruiting
    - Brigham and Women's Hospital
  - Boston, Massachusetts, United States, 02215
    - Recruiting
    - Dana Farber Cancer Institute
    - Principal Investigator:
      
      Sara Tolaney
  - Boston, Massachusetts, United States, 02114
    - Recruiting
    - Massachusetts General Hospital.
  - Newton, Massachusetts, United States, 02459
    - Recruiting
    - Dana Farber Cancer Institute- Chestnut Hill
- Missouri
  - City of Saint Peters, Missouri, United States, 63376
    - Recruiting
    - Siteman Cancer Center - St Peters
  - Creve Coeur, Missouri, United States, 63141
    - Recruiting
    - Siteman Cancer Center - West County
  - Florissant, Missouri, United States, 63031
    - Recruiting
    - Siteman Cancer Center - North County
  - Kansas City, Missouri, United States, 64111
    - Recruiting
    - Saint Luke's Cancer Institute LLC
    - Principal Investigator:
      
      Timothy J Pluard
    - Contact:
      
      Timothy J Pluard
      
      Phone Number: 816-932-6005
      
      Email: tpluard@saintlukeskc.org
  - Kansas City, Missouri, United States, 64111
    - Recruiting
    - Saint Luke's Hospital Investigational Pharmacy
  - St Louis, Missouri, United States, 63110
    - Recruiting
    - Washington University School of Medicine
  - St Louis, Missouri, United States, 63110
    - Recruiting
    - Washington University School of Medicine - Siteman Cancer Center
  - St Louis, Missouri, United States, 63110
    - Recruiting
    - Barnes-Jewish Hospital
  - St Louis, Missouri, United States, 63129
    - Recruiting
    - Siteman Cancer Center - South County
- Nevada
  - Reno, Nevada, United States, 89502
    - Recruiting
    - Renown Regional Medical Center
- New Jersey
  - Basking Ridge, New Jersey, United States, 07920
    - Recruiting
    - MSK Basking Ridge
  - Middletown, New Jersey, United States, 07748
    - Recruiting
    - MSK Monmouth.
  - Montvale, New Jersey, United States, 07645
    - Recruiting
    - MSK Bergen.
- New Mexico
  - Farmington, New Mexico, United States, 87401
    - Terminated
    - San Juan Oncology Associates
- New York
  - Commack, New York, United States, 11725
    - Recruiting
    - MSK Commack.
  - Harrison, New York, United States, 10604
    - Recruiting
    - MSK Westchester.
  - Long Island City, New York, United States, 11101
    - Recruiting
    - Investigational Drug Service
  - New York, New York, United States, 10065
    - Recruiting
    - Memorial Sloan Kettering Cancer Center
    - Principal Investigator:
      
      Shanu Modi
    - Contact:
      
      Shanu Modi
      
      Phone Number: 646-888-4564
      
      Email: modis@mskcc.org
  - New York, New York, United States, 10065
    - Recruiting
    - Memorial Sloan Kettering Cancer Center - Main Hospital
  - Uniondale, New York, United States, 11553
    - Recruiting
    - MSK Nassau.
- Ohio
  - Columbus, Ohio, United States, 43219
    - Recruiting
    - Zangmeister Cancer Center
    - Contact:
      
      Sameh Mikhail
      
      Phone Number: 614-383-6000
      
      Email: Sameh.Mikhail@aoncology.com
    - Principal Investigator:
      
      Sameh Mikhail
- South Carolina
  - Greenville, South Carolina, United States, 29607
    - Recruiting
    - Saint Francis Hospital / Bon Secours - South Carolina
    - Principal Investigator:
      
      Robert D Siegel
- Tennessee
  - Nashville, Tennessee, United States, 37203
    - Not yet recruiting
    - SCRI Oncology Partners
  - Nashville, Tennessee, United States, 37203
    - Not yet recruiting
    - Sarah Cannon Research Institute - Pharmacy
  - Nashville, Tennessee, United States, 37203
    - Not yet recruiting
    - Tennessee Oncology-Nashville/Sarah Cannon Research Institute
- Texas
  - Dallas, Texas, United States, 75390
    - Not yet recruiting
    - University of Texas Southwestern Medical Center
  - Dallas, Texas, United States, 75235
    - Not yet recruiting
    - Parkland Health and Hospital System
  - Dallas, Texas, United States, 75235
    - Not yet recruiting
    - University of Texas Southwestern Medical Center - Simmons Cancer Center
  - Dallas, Texas, United States, 75235
    - Not yet recruiting
    - University of Texas Southwestern Medical Center-Simmons Cancer Center Pharmacy
  - Dallas, Texas, United States, 75237
    - Not yet recruiting
    - University of Texas Southwestern Medical Center Simmons Cancer Center - Redbird
  - Dallas, Texas, United States, 75390
    - Not yet recruiting
    - University of Texas Southwestern Medical Center Clinical Lab-Zale Lipshy University Hospital
  - Dallas, Texas, United States, 75390
    - Not yet recruiting
    - University of Texas Southwestern Medical Center-William P. Clements Jr. University Hospital
  - Fort Worth, Texas, United States, 76104
    - Not yet recruiting
    - University of Texas Southwestern Simmons Cancer Center - Fort Worth
  - Richardson, Texas, United States, 75080
    - Not yet recruiting
    - University of Texas Southwestern Medical Center Simmons Cancer Center - Richardson/Plano
- Washington
  - Seattle, Washington, United States, 98195
    - Recruiting
    - University of Washington Medical Center
  - Seattle, Washington, United States, 98104
    - Recruiting
    - Harborview Medical Center
  - Seattle, Washington, United States, 98109
    - Recruiting
    - Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington
- Wisconsin
  - Madison, Wisconsin, United States, 53792
    - Recruiting
    - Carbone Cancer Center / University of Wisconsin
    - Principal Investigator:
      
      Malinda West
    - Contact:
      
      University of Wisconsin Carbone Cancer Center CT.Gov Inbox
      
      Email: cancerconnect@uwcarbone.wisc.edu
  - Madison, Wisconsin, United States, 53718
    - Recruiting
    - University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

General Inclusion Criteria

Measurable disease according to RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1

Dose Escalation and Optimization Phase Inclusion Criteria

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.

Cohort A (HER2-Low Breast Cancer) Inclusion Criteria

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.

Cohort B (HER2+ Breast Cancer) Inclusion Criteria

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

Cohort C (HER2-Low Gastric or Gastroesophageal Junction Adenocarcinoma) Inclusion Criteria

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

Cohort D (HER2+ LA/mGC/GEJC) Inclusion Criteria

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:

Known hypersensitivity to any excipient contained in the drug formulation of disitamab vedotin or tucatinib
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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Sequential Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Escalation - Previously treated advanced GC/GEJC or breast cancer disitamab vedotin + tucatinib	Drug: disitamab vedotin Given into the vein (IV; intravenous) Other Names: RC48, RC48-ADC Drug: tucatinib 300mg given twice daily by mouth (orally) Other Names: TUKYSA, ONT-380, ARRY-380
Experimental: Dose Optimization - HER2-low and HER2+ LA/mBC disitamab vedotin + tucatinib	Drug: disitamab vedotin Given into the vein (IV; intravenous) Other Names: RC48, RC48-ADC Drug: tucatinib 300mg given twice daily by mouth (orally) Other Names: TUKYSA, ONT-380, ARRY-380
Experimental: Dose Optimization - HER2-low and HER2+ LA/mGC/GEJC disitamab vedotin + tucatinib	Drug: disitamab vedotin Given into the vein (IV; intravenous) Other Names: RC48, RC48-ADC Drug: tucatinib 300mg given twice daily by mouth (orally) Other Names: TUKYSA, ONT-380, ARRY-380
Experimental: Dose Expansion - HER2-low LA/mBC disitamab vedotin + tucatinib	Drug: disitamab vedotin Given into the vein (IV; intravenous) Other Names: RC48, RC48-ADC Drug: tucatinib 300mg given twice daily by mouth (orally) Other Names: TUKYSA, ONT-380, ARRY-380
Experimental: Dose Expansion - HER2+ LA/mBC disitamab vedotin + tucatinib	Drug: disitamab vedotin Given into the vein (IV; intravenous) Other Names: RC48, RC48-ADC Drug: tucatinib 300mg given twice daily by mouth (orally) Other Names: TUKYSA, ONT-380, ARRY-380
Experimental: Dose Expansion - HER2-low LA/mGC/GEJC disitamab vedotin + tucatinib	Drug: disitamab vedotin Given into the vein (IV; intravenous) Other Names: RC48, RC48-ADC Drug: tucatinib 300mg given twice daily by mouth (orally) Other Names: TUKYSA, ONT-380, ARRY-380
Experimental: Dose Expansion - HER2+ LA/mGC/GEJC disitamab vedotin + tucatinib	Drug: disitamab vedotin Given into the vein (IV; intravenous) Other Names: RC48, RC48-ADC Drug: tucatinib 300mg given twice daily by mouth (orally) Other Names: TUKYSA, ONT-380, ARRY-380

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events (AEs) Time Frame: Through 30 days after the last study treatment; 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	Through 30 days after the last study treatment; approximately 5 years
Number of participants with laboratory abnormalities Time Frame: Through 30-37 days after the last study treatment: approximately 5 years		Through 30-37 days after the last study treatment: approximately 5 years
Number of participants with dose alterations Time Frame: Through 30-37 days after the last study treatment: approximately 5 years		Through 30-37 days after the last study treatment: approximately 5 years
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment Time Frame: Approximately 3 years	The proportion of participants with confirmed response (CR) or partial response (PR) according to RECIST v1.1.	Approximately 3 years
Number of participants with dose limiting toxicities (DLTs) in dose escalation phase Time Frame: Up to 28 days		Up to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of response (DOR) per RECIST v1.1 by investigator assessment Time Frame: 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	Approximately 5 years
Disease control rate (DCR) per RECIST v1.1 by investigator assessment Time Frame: Approximately 5 years	The proportion of participants with stable disease (SD) or confirmed CR or PR according to RECIST v1.1.	Approximately 5 years
Pharmacokinetic (PK) parameter - Maximum concentration (Cmax) Time Frame: Through 30-37 days after the last study treatment; approximately 5 years		Through 30-37 days after the last study treatment; approximately 5 years
PK parameter - Area under the concentration-time curve to the time of the last quantifiable concentration (AUClast) Time Frame: Approximately 1 month		Approximately 1 month
Incidence of anti-drug antibodies (ADAs) against disitamab vedotin Time Frame: Through 30-37 days after the last study treatment; approximately 5 years		Through 30-37 days after the last study treatment; approximately 5 years
Progression free survival (PFS) per RECIST v1.1 by investigator assessment Time Frame: Approximately 5 years	The time from the start of any study treatment (or randomization date for participants in dose optimization phase) to the first documentation of disease progression per RECIST v1.1 or death due to any cause.	Approximately 5 years
Overall survival (OS) Time Frame: Approximately 5 years	The time from the start of any study treatment (or randomization date for participants in dose optimization phase) to the date of death due to any cause.	Approximately 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen, a wholly owned subsidiary of Pfizer

Collaborators

RemeGen Co., Ltd.

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

To obtain contact information for a study center near you, click here.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2024

Primary Completion (Estimated)

July 28, 2029

Study Completion (Estimated)

July 28, 2029

Study Registration Dates

First Submitted

November 27, 2023

First Submitted That Met QC Criteria

November 27, 2023

First Posted (Actual)

December 6, 2023

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

SGNDV-004
C5731004 (Other Identifier: Alias Study Number)
2023-507555-29-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Stomach Neoplasms

Clinical Trials on disitamab vedotin

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