A Study of Disitamab Vedotin in Adults With HER2 Expressing Advanced Breast Cancer

September 4, 2026 updated by: Pfizer

A PHASE 1B/2, OPEN-LABEL, MULTICOHORT STUDY OF DISITAMAB VEDOTIN IN ADULTS WITH HER2 EXPRESSING ADVANCED BREAST CANCER

The purpose of this clinical study is to learn about the safety and effects of the study medicine (called disitamab vedotin) for the possible treatment of people with breast cancer that is hard to treat and has spread in the body (advanced cancer).

This study is seeking participants who:

  • have breast cancer that is hard to treat and has spread in the body (advanced cancer)
  • have tumors that have HER2 on them
  • have received previous treatment for their advanced breast cancer

All participants in this study will receive disitamab vedotin at the study clinic once every 2 weeks as an intravenous (IV) infusion (given directly into a vein).

Participants will take the study medicine until they or their doctor decides to stop. This might be because their cancer is getting worse, the study medicine is no longer helping, they have bad side effects, or they wish to stop taking the study medicine. During this time, the participants will have study visits every 2 weeks. After the participants have stopped taking the study medicine, they will have follow-up visits about every 6 weeks unless their cancer gets worse. After that, they will have follow-up phone calls about every 12 weeks.

The study team will look at the experiences of people receiving the study medicine. This will help the study team decide if the study medicine is safe and effective.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Locations

  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Blacktown Hospital
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital
    • Victoria
      • St Albans, Victoria, Australia, 3021
        • Western Health-Sunshine & Footscray Hospitals
  • Brazil
    • Santa Catarina
      • Lages, Santa Catarina, Brazil, 88501001
        • ANIMI - Unidade de Tratamento Oncologico
    • São Paulo
      • São Caetano do Sul, São Paulo, Brazil, 09541-270
        • Centro de Oncologia - CEON+ - Unidade São Caetano do Sul
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Arthur J.E. Child Comprehensive Cancer Centre
    • Ontario
      • Kitchener, Ontario, Canada, N2G 1G3
        • Waterloo Regional Health Network
      • Oshawa, Ontario, Canada, L1G 2B9
        • Lakeridge Health
  • Germany
      • Berlin, Germany, 10117
        • Charité University Hospital Berlin
      • Leipzig, Germany, 04103
        • Universitatsklinikum Leipzig
    • North Rhine-Westphalia
      • Essen, North Rhine-Westphalia, Germany, 45136
        • Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • University Hospital Carl Gustav Carus, Technical University Dresden
  • Italy
      • Bologna, Italy, 40138
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    • Campania
      • Naples, Campania, Italy, 80131
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italy, 47014
        • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
    • Pordenone
      • Aviano, Pordenone, Italy, 33081
        • Cro-Irccs
    • Tuscany
      • Livorno, Tuscany, Italy, 57124
        • Azienda USL Toscana Nord Ovest_Ospedale Civile di Livorno
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 464-8681
        • Aichi Cancer Center
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 2418515
        • Kanagawa Cancer Center
    • Osaka
      • Suita, Osaka, Japan, 565-0871
        • The University of Osaka Hospital
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
      • Koto, Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital of JFCR
  • Puerto Rico
      • Rio Piedras, Puerto Rico, 00935
        • Pan American Center for Oncology Trials, LLC
  • Spain
      • Granada, Spain, 18012
        • Hospital Universitario Virgen Nieves
      • Madrid, Spain, 28007
        • Hospital Beata Maria Ana
    • Barcelona [barcelona]
      • Barcelona, Barcelona [barcelona], Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Barcelona [barcelona], Spain, 08003
        • Parc de Salut Mar - Hospital del Mar
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28046
        • Hospital Universitario La Paz
    • Málaga
      • Málaga, Málaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46010
        • Hospital Clínico de Valencia
  • United States
    • Alabama
      • Daphne, Alabama, United States, 36526
        • Southern Cancer Center, PC
      • Foley, Alabama, United States, 36535
        • Southern Cancer Center, PC
      • Mobile, Alabama, United States, 36608
        • Southern Cancer Center, PC
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner MD Anderson Cancer Center
      • Gilbert, Arizona, United States, 85234
        • Banner Gateway Medical Center
    • California
      • Anaheim, California, United States, 92805
        • Oncura Health - Anaheim
      • Duarte, California, United States, 91010
        • City of Hope National Medical Center
      • Emeryville, California, United States, 94608
        • Stanford Cancer Center Emeryville
      • Fountain Valley, California, United States, 92708
        • Oncura Health - Fountain Valley
      • Glendale, California, United States, 91204
        • Oncura Health - Corporate
      • Irvine, California, United States, 92618
        • City of Hope at Irvine Lennar
      • Los Angeles, California, United States, 90067
        • Valkyrie Clinical Trials
      • Los Angeles, California, United States, 90017
        • Oncura Health - Good Samaritan
      • Los Angeles, California, United States, 91402
        • Mission Community Hospital (Satellite Site)
      • Palo Alto, California, United States, 94304
        • Stanford Cancer Center
      • Palo Alto, California, United States, 94304
        • Stanford Women's Cancer Center
      • Palo Alto, California, United States, 94304
        • Clinical and Translational Research Unit (CTRU)
      • Pleasanton, California, United States, 94588
        • Stanford Cancer Center Pleasanton
      • Portola, California, United States, 94208
        • Stanford Healthcare - Portola Valley
      • San Jose, California, United States, 95124
        • Stanford University Cancer Center South Bay
      • Stanford, California, United States, 94305
        • Stanford Health Care, Investigational Drug Service
      • Van Nuys, California, United States, 91405
        • Oncura Health -Valley Presbyterian
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Rocky Mountain Cancer Centers, LLP
      • Boulder, Colorado, United States, 80303
        • Rocky Mountain Cancer Centers, LLP
      • Centennial, Colorado, United States, 80112
        • Rocky Mountain Cancer Centers, LLP
      • Colorado Springs, Colorado, United States, 80907
        • Rocky Mountain Cancer Centers, LLP
      • Colorado Springs, Colorado, United States, 80923
        • Rocky Mountain Cancer Centers, LLP
      • Denver, Colorado, United States, 80220
        • Rocky Mountain Cancer Centers, LLP
      • Englewood, Colorado, United States, 80113
        • Rocky Mountain Cancer Centers, LLP
      • Lakewood, Colorado, United States, 80228
        • Rocky Mountain Cancer Centers, LLP
      • Littleton, Colorado, United States, 80120
        • Rocky Mountain Cancer Centers, LLP
      • Lone Tree, Colorado, United States, 80124
        • Rocky Mountain Cancer Centers, LLP
      • Longmont, Colorado, United States, 80504
        • Rocky Mountain Cancer Centers, LLP
      • Pueblo, Colorado, United States, 81003
        • Rocky Mountain Cancer Centers, LLP
      • Thornton, Colorado, United States, 80260
        • Rocky Mountain Cancer Centers, LLP
    • Connecticut
      • Derby, Connecticut, United States, 06418
        • Smilow Cancer Hospital - Derby
      • Fairfield, Connecticut, United States, 06824
        • Smilow Cancer Hospital - Fairfield
      • Glastonbury, Connecticut, United States, 06033
        • Smilow Cancer Hospital - Glastonbury
      • Greenwich, Connecticut, United States, 06830
        • Smilow Cancer Hospital - Greenwich
      • Guilford, Connecticut, United States, 06437
        • Smilow Cancer Hospital - Guilford
      • Hartford, Connecticut, United States, 06105
        • Smilow Cancer Hospital at St. Francis
      • New Haven, Connecticut, United States, 06510
        • Yale-New Haven Hospital
      • New Haven, Connecticut, United States, 06520
        • Yale School of Medicine
      • New Haven, Connecticut, United States, 06510
        • Smilow Cancer Hospital - Yale New Haven Health
      • New Haven, Connecticut, United States, 06511
        • Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOP
      • North Haven, Connecticut, United States, 06473
        • Smilow Cancer Hospital - North Haven
      • Stamford, Connecticut, United States, 06902
        • Smilow Cancer Hospital - Long Ridge
      • Torrington, Connecticut, United States, 06790
        • Smilow Cancer Hospital - Torrington
      • Trumbull, Connecticut, United States, 06611
        • Smilow Cancer Hospital - Trumbull
      • Waterbury, Connecticut, United States, 06708
        • Smilow Cancer Hospital - Waterbury
      • Waterford, Connecticut, United States, 06385
        • Smilow Cancer Hospital - Waterford
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • MedStar Georgetown University Hospital
      • Washington D.C., District of Columbia, United States, 20007
        • Georgetown University Medical Center - Department of Pharmacy, Oncology Pharmacy
    • Florida
      • Clearwater, Florida, United States, 33761
        • Florida Cancer Specialists
      • Coral Gables, Florida, United States, 33146
        • Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center
      • Coral Springs, Florida, United States, 33065
        • Sylvester Comprehensive Cancer Center - Coral Springs
      • Deerfield Beach, Florida, United States, 33442
        • University of Miami Hospital and Clinics - Deerfield Beach
      • Doral, Florida, United States, 33166
        • Sylvester Comprehensive Cancer Center- Doral
      • Gainesville, Florida, United States, 32605
        • Florida Cancer Specialists
      • Hollywood, Florida, United States, 33021
        • Sylvester Comprehensive Cancer Center - Hollywood
      • Largo, Florida, United States, 33770
        • Florida Cancer Specialists
      • Lecanto, Florida, United States, 34461
        • Florida Cancer Specialists
      • Miami, Florida, United States, 33136
        • Sylvester Comprehensive Cancer Center
      • Miami, Florida, United States, 33136
        • University of Miami Hospital and Clinics
      • Miami, Florida, United States, 33176
        • Sylvester Comprehensive Cancer Center - Kendall
      • North Miami, Florida, United States, 33181
        • Sylvester Comprehensive Cancer Center - Sole Mia
      • Ocala, Florida, United States, 34474
        • Florida Cancer Specialists
      • Orange City, Florida, United States, 32763
        • Florida Cancer Specialists
      • Orlando, Florida, United States, 32806
        • Florida Cancer Specialists
      • Plantation, Florida, United States, 33324
        • Sylvester Comprehensive Cancer Center - Plantation
      • St. Petersburg, Florida, United States, 33705
        • Florida Cancer Specialists
      • St. Petersburg, Florida, United States, 33701
        • Florida Cancer Specialists
      • Tallahassee, Florida, United States, 32308
        • Florida Cancer Specialists
      • Tampa, Florida, United States, 33607
        • Florida Cancer Specialists
      • Tavares, Florida, United States, 32778
        • Florida Cancer Specialists
      • The Villages, Florida, United States, 32159
        • Florida Cancer Specialists
      • Trinity, Florida, United States, 34655
        • Florida Cancer Specialists
      • Winter Park, Florida, United States, 32789
        • Florida Cancer Specialists
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute
      • Atlanta, Georgia, United States, 30308
        • Winship Cancer Institute @ Emory University Hospital Midtown
      • Atlanta, Georgia, United States, 30322
        • Emory Clinic Investigational Drug Services
    • Oregon
      • Albany, Oregon, United States, 97321
        • Oncology Associates of Oregon, P.C.
      • Eugene, Oregon, United States, 97401
        • Oncology Associates of Oregon, P.C.
      • Springfield, Oregon, United States, 97477
        • Oncology Associates of Oregon, P.C.
    • Pennsylvania
      • Bensalem, Pennsylvania, United States, 19020
        • Alliance Cancer Specialists, PC
      • Doylestown, Pennsylvania, United States, 18901
        • Alliance Cancer Specialists, PC
      • Horsham, Pennsylvania, United States, 19044
        • Alliance Cancer Specialists, PC
      • Langhorne, Pennsylvania, United States, 19047
        • Alliance Cancer Specialists, PC
      • Media, Pennsylvania, United States, 19063
        • Alliance Cancer Specialists, PC
      • Sellersville, Pennsylvania, United States, 18960
        • Alliance Cancer Specialists, PC
      • Wynnewood, Pennsylvania, United States, 19096
        • Alliance Cancer Specialists, PC
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute - Pharmacy
      • Nashville, Tennessee, United States, 37203
        • SCRI Oncology Partners
    • Texas
      • Allen, Texas, United States, 75013
        • Texas Oncology-Northeast Texas
      • Arlington, Texas, United States, 76012
        • Texas Oncology - DFW
      • Arlington, Texas, United States, 76014
        • Texas Oncology - DFW
      • Bedford, Texas, United States, 76022
        • Texas Oncology - DFW
      • Dallas, Texas, United States, 75246
        • Texas Oncology - DFW
      • Dallas, Texas, United States, 75231
        • Texas Oncology - DFW
      • Dallas, Texas, United States, 75203
        • Texas Oncology - DFW
      • Dallas, Texas, United States, 75230
        • Texas Oncology - DFW
      • Dallas, Texas, United States, 75237
        • Texas Oncology - DFW
      • Denison, Texas, United States, 75020
        • Texas Oncology-Northeast Texas
      • Denton, Texas, United States, 76201
        • Texas Oncology-Northeast Texas
      • Flower Mound, Texas, United States, 75028
        • Texas Oncology-Northeast Texas
      • Fort Worth, Texas, United States, 76104
        • Texas Oncology - DFW
      • Grapevine, Texas, United States, 76051
        • Texas Oncology - DFW
      • Irving, Texas, United States, 75063
        • US Oncology Investigational Product Center (IPC)
      • Irving, Texas, United States, 75063
        • US Oncology Investigation Products Center(IPC)
      • Lewisville, Texas, United States, 75056
        • Texas Oncology-Northeast Texas
      • Longview, Texas, United States, 75601
        • Texas Oncology-Northeast Texas
      • McKinney, Texas, United States, 75071
        • Texas Oncology-Northeast Texas
      • Palestine, Texas, United States, 75801
        • Texas Oncology-Northeast Texas
      • Paris, Texas, United States, 75460
        • Texas Oncology-Northeast Texas
      • Plano, Texas, United States, 75075
        • Texas Oncology - DFW
      • Plano, Texas, United States, 75093
        • Texas Oncology - DFW
      • San Antonio, Texas, United States, 78240
        • Texas Oncology - San Antonio
      • San Antonio, Texas, United States, 78217
        • Texas Oncology - San Antonio
      • Tyler, Texas, United States, 75702
        • Texas Oncology-Northeast Texas
    • Virginia
      • Arlington, Virginia, United States, 22201
        • Virginia Cancer Specialists, PC
      • Blacksburg, Virginia, United States, 24060
        • Oncology & Hematology Associates of Southwest Virginia Inc dba Blue Ridge Cancer Care
      • Chesapeake, Virginia, United States, 23320
        • Virginia Oncology Associates
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists, PC
      • Low Moor, Virginia, United States, 24457
        • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
      • Manassas, Virginia, United States, 20110
        • Virginia Cancer Specialists, PC
      • Newport News, Virginia, United States, 23606
        • Virginia Oncology Associates
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates
      • Reston, Virginia, United States, 20190
        • Virginia Cancer Specialists, PC
      • Roanoke, Virginia, United States, 24014
        • Oncology & Hematology Associates of Southwest Virginia Inc dba Blue Ridge Cancer Care
      • Salem, Virginia, United States, 24153
        • Oncology & Hematology Associates of Southwest Virginia Inc dba Blue Ridge Cancer Care
      • Virginia Beach, Virginia, United States, 23456
        • Virginia Oncology Associates
      • Williamsburg, Virginia, United States, 23188
        • Virginia Oncology Associates
      • Wytheville, Virginia, United States, 24382
        • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute
      • Seattle, Washington, United States, 98122
        • Swedish 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

No

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of locally-advanced, unresectable, or metastatic breast carcinoma.
  • Human epidermal growth factor receptor 2 (HER2) and hormone receptor (HR) status appropriate for enrollment in cohort.
  • HER2 status determined by most recent local assessment based on American Society of Clinical Oncology (ASCO) and College of American Pathologists (CAP) guidelines for assessment of HER2 in BC for interpretation of HER2 expression and amplification
  • HER2+: immunohistochemistry (IHC) 3+ or IHC 2+/in situ hybridization (ISH)+
  • HER2-low: IHC 1+/ISH-negative or untested or IHC 2+/ISH-negative
  • HER2-ultralow: IHC 0 with membrane staining (any staining of the membrane in >0 and ≤10% of cancer cells) o HR+ disease is determined as either estrogen receptor (ER) and/or progesterone receptor (PgR) positive [ER or PgR ≥1%]) and HR negative disease is determined as both ER and PR negative [ER and PgR <1%]) per ASCO/CAP guidelines in the advanced disease setting. If a patient has had multiple ER/PgR results for advanced disease, the most recent test result will be used to confirm eligibility.

Prior therapy requirements for Cohort 1 (HER2+, HR+ or HR- participants):

  • Received prior trastuzumab, pertuzumab and a taxane if available as local first line standard of care therapy for advanced disease.
  • Prior tucatinib based therapy is allowed.
  • Must have progression on or after, or be intolerant to, T-DXd in any line advanced disease setting.
  • No more than 3 prior systemic cytotoxic therapy regimens (including antibody drug conjugates [ADCs]) for Locally Advanced (LA)/metastatic breast cancer (mBC). Participants previously treated with (neo)adjuvant cytotoxic therapy and have disease relapsed within 6 months of cytotoxic treatment is considered to have received 1 line of cytotoxic therapy for LA/mBC.

Prior therapy requirements for Cohort 2 (HR+/HER2-low participants):

  • No more than 3 prior systemic cytotoxic therapy regimens (including ADCs) for LA/mBC. Participants previously treated with (neo)adjuvant cytotoxic therapy and have disease relapsed within 6 months of cytotoxic treatment is considered to have received 1 line of cytotoxic therapy for LA/mBC.
  • Participants with known germline breast cancer gene (BRCA) mutation must have received a poly-ADP ribose polymerase (PARP) inhibitor, where available and not medically contraindicated.
  • Must have progression on or after, or be intolerant to, trastuzumab deruxtecan (T-DXd) in any line advanced disease setting.
  • Must have intolerance to endocrine therapy (ET) or ET refractory disease:
  • Progressed on ≥2 lines of ET for LA/mBC AND had received a cyclin-dependent kinase (CDK)4/6 inhibitor in the adjuvant or metastatic setting if available as local standard of care and not contraindicated.

OR

• Progressed on 1 line of ET for LA/mBC AND had a relapse while on adjuvant ET after definitive surgery for primary tumor AND had received a cyclin-dependent kinase (CDK) 4/6 inhibitor in the adjuvant or advanced setting if available as local standard of care and not contraindicated.

Prior therapy requirements for Cohort 3 (HR+/HER2-ultralow or HR-/HER2-low [HER2 low TNBC] participants):

  • No more than 4 prior systemic cytotoxic chemotherapy regimens (including ADCs) for advanced or mBC. Participants previously treated with (neo)adjuvant cytotoxic therapy and have disease relapsed within 6 months of cytotoxic treatment is considered to have received 1 line of cytotoxic therapy for LA/mBC.
  • Known germline BRCA mutation must have received a PARP-inhibitor if available as local standard of care therapy and not medically contraindicated.
  • Prior sacituzumab govitecan is allowed.
  • Prior T-DXd is allowed.
  • Participants with HR negative (TNBC), HER2-low and programmed cell death receptor ligand 1 (PD-L1)-positive (combined positive score [CPS] ≥10) tumors must have received pembrolizumab (or other PD-L1 inhibitor) with chemotherapy if available as local standard of care therapy and not medically contraindicated.
  • Participants with HR+/HER2-ultra low tumors must have received at least 1 antihormonal therapy in any setting or be ineligible for ET.
  • Participants with HR+/HER2-ultra low tumors must have had prior therapy with a CDK4/6 inhibitor in the adjuvant or advanced setting.

Exclusion Criteria:

  • Known hypersensitivity to any excipient contained in the drug formulation of disitamab vedotin.
  • Active central nervous system (CNS) and/or leptomeningeal metastasis.
  • Participants with a history of other invasive malignancy within 3 years before the Cycle 1 Day 1 (C1D1) of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.
  • Prior therapy with ADCs with MMAE payload.

  • Participants who have received prior systemic anticancer treatment or radiotherapy within 2 weeks, or 5 half-lives, whichever is shorter, prior to C1D1 of study intervention. Note: If the last immediate anticancer treatment contained an antibody-based agent(s), then an interval of 28 days or 5 half-lives (whichever is shorter) of the agent(s) prior to receiving the study intervention treatment is required.

    • Participants must have recovered from all adverse events due to previous therapies.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1: HER2+ locally advanced or metastatic breast cancer
disitamab vedotin monotherapy
Drug: Disitamab vedotin
Given into the vein (IV; intravenous) every 2 weeks.
Other Names:
  • RC48
  • RC48-ADC
Experimental: Cohort 2: HR+, HER2-low locally advanced or metastatic breast cancer
disitamab vedotin monotherapy
Drug: Disitamab vedotin
Given into the vein (IV; intravenous) every 2 weeks.
Other Names:
  • RC48
  • RC48-ADC
Experimental: Cohort 3: HR+, HER2 ultra-low or HR-negative, HER2-low locally advanced or metastatic breast cancer
disitamab vedotin monotherapy
Drug: Disitamab vedotin
Given into the vein (IV; intravenous) every 2 weeks.
Other Names:
  • RC48
  • RC48-ADC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response (OR) by investigator assessment
Time Frame: From Cycle 1 Day 1 until disease progression by investigator assessment per RECIST version 1.1, or death due to any cause, whichever is earlier; up to approximately 2 years
The primary endpoint OR by investigator assessment is defined as the proportion of participants with confirmed CR or PR as determined by investigator per RECIST Version 1.1.
From Cycle 1 Day 1 until disease progression by investigator assessment per RECIST version 1.1, or death due to any cause, whichever is earlier; up to approximately 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of response (DOR) per RECIST v1.1 by investigator assessment
Time Frame: From first documentation of objective response (CR or PR) by investigator assessment per RECIST version 1.1 that is subsequently confirmed, to the first documentation of progressive disease or to death due to any cause; up to approximately 2 years
DOR by investigator assessment is defined as the time from first documentation of objective response (CR or PR) by investigator assessment per RECIST version 1.1 that is subsequently confirmed, to the first documentation of progressive disease or to death due to any cause, whichever comes first.
From first documentation of objective response (CR or PR) by investigator assessment per RECIST version 1.1 that is subsequently confirmed, to the first documentation of progressive disease or to death due to any cause; up to approximately 2 years
Progression-free survival (PFS) per RECIST v1.1 by investigator assessment
Time Frame: From Cycle 1 Day 1 until disease progression by investigator assessment per RECIST version 1.1, or death due to any cause, whichever is earlier; ; up to approximately 2 years
PFS by investigator assessment is defined as the time from C1D1 to the first documentation of disease progression as determined by investigator per RECIST version 1.1, or to death due to any cause, whichever comes first.
From Cycle 1 Day 1 until disease progression by investigator assessment per RECIST version 1.1, or death due to any cause, whichever is earlier; ; up to approximately 2 years
Overall survival (OS)
Time Frame: From Cycle 1 Day 1 until death due to any cause; up to approximately 3 years
OS is defined as the time from C1D1 to date of death due to any cause.
From Cycle 1 Day 1 until death due to any cause; up to approximately 3 years
Incidence of anti-drug antibodies (ADA) against disitamab vedotin
Time Frame: From Cycle 1 Day 1 to end of treatment; up to approximately 2 years
The percentage of participants with positive ADA will be summarized.
From Cycle 1 Day 1 to end of treatment; up to approximately 2 years
Disease control rate (DCR) (confirmed CR, confirmed PR, and stable disease) per RECIST v1.1 by investigator assessment
Time Frame: From Cycle 1 Day 1 until disease progression by investigator assessment per RECIST version 1.1, or death due to any cause, whichever is earlier; up to approximately 2 years
DCR by investigator assessment is defined as the proportion of participants with CR or PR with confirmation, or Stable Disease (SD) by investigator assessment per RECIST version 1.1.
From Cycle 1 Day 1 until disease progression by investigator assessment per RECIST version 1.1, or death due to any cause, whichever is earlier; up to approximately 2 years
PK Parameter: Serum Concentrations of disitamab vedotin, total antibody, and unconjugated MMAE
Time Frame: From Cycle 1 Day 1 to end of treatment; up to approximately 2 years
The Antibody-drug conjugate (TAb), and unconjugated Monomethyl auristatin E (MMAE) concentrations for disitamab vedotin summarized at each PK sampling time point.
From Cycle 1 Day 1 to end of treatment; up to approximately 2 years
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
Time Frame: Up to approximately 2 years
Type, incidence, severity, seriousness, and relatedness of AEs. Type, incidence, and severity of laboratory abnormalities and significant changes from baseline.
Up to approximately 2 years

Collaborators and Investigators

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

Sponsor

Pfizer

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

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)

June 30, 2025

Primary Completion (Estimated)

October 25, 2027

Study Completion (Estimated)

January 27, 2030

Study Registration Dates

First Submitted

May 9, 2025

First Submitted That Met QC Criteria

May 9, 2025

First Posted (Actual)

May 11, 2025

Study Record Updates

Last Update Posted (Actual)

September 9, 2026

Last Update Submitted That Met QC Criteria

September 4, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C5731006
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-521003-52-00 (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

No

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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