Clinical trial • Phase I/II • Oncology

DISITAMAB VEDOTIN for HER2 expressing advanced breast cancer

Phase I/II trial of DISITAMAB VEDOTIN for HER2 expressing advanced breast cancer. open-label. 64 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
HER2 expressing advanced breast cancer
Trial Stage
Phase I/II
Drug Modality
ADC

Key dates

Initial CTIS Submission Date
30-07-2025
First CTIS Authorization Date
18-11-2025

Trial design

open-label Phase I/II trial across 21 sites in Germany, Italy, Spain.

Open Label
Yes
Biomarker Stratified
True; HER2 (HER2+, HER2-low, HER2-ultralow) and HR (HR+, HR-)
Target Sample Size
64

Eligibility

Recruits 64 No vulnerable populations selected; trial includes adults only; subject information and informed consent forms are present for participants (multiple language versions available). No assent procedures for minors are indicated..

Vulnerable Population
No vulnerable populations selected; trial includes adults only; subject information and informed consent forms are present for participants (multiple language versions available). No assent procedures for minors are indicated.

Inclusion criteria

  • {"criterion_text":"- Histologically or cytologically confirmed diagnosis of locally-advanced, unresectable, or metastatic breast carcinoma.\n- HER2 and HR status appropriate for enrollment in cohort.\n- 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.\n- 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."}

Exclusion criteria

  • {"criterion_text":"- Known hypersensitivity to any excipient contained in the drug formulation of disitamab vedotin.\n- Central nervous system (CNS) and/or leptomeningeal metastasis.\n- 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.\n- Prior therapy with ADCs with MMAE payload.\n- 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."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Objective response (OR) (confirmed complete response [CR] and confirmed partial response [PR]) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment.","definition_or_measurement_approach":"Measured by investigator assessment per RECIST v1.1; OR defined as confirmed CR or confirmed PR."}

Secondary endpoints

  • {"endpoint_text":"- Duration of response (DOR) per RECIST v1.1 by investigator assessment.","definition_or_measurement_approach":"Measured per RECIST v1.1 by investigator assessment; duration from first documented response until progression or death."}
  • {"endpoint_text":"- Disease control rate (DCR) (confirmed CR, confirmed PR, and stable disease) per RECIST v1.1 by investigator assessment.","definition_or_measurement_approach":"Measured per RECIST v1.1 by investigator assessment; DCR includes confirmed CR, confirmed PR, and stable disease."}
  • {"endpoint_text":"- Progression-free survival (PFS) per RECIST v1.1 by investigator assessment.","definition_or_measurement_approach":"Time from randomization/enrollment to disease progression per RECIST v1.1 or death, assessed by investigator."}
  • {"endpoint_text":"- Overall survival (OS).","definition_or_measurement_approach":"Time from randomization/enrollment to death from any cause."}
  • {"endpoint_text":"- Estimates of selected PK parameters of disitamab vedotin, total antibody, and unconjugated MMAE.","definition_or_measurement_approach":"Pharmacokinetic sampling and analysis to estimate standard PK parameters for disitamab vedotin, total antibody, and unconjugated MMAE."}
  • {"endpoint_text":"- Incidence of anti-drug antibodies (ADA) against disitamab vedotin.","definition_or_measurement_approach":"Immunogenicity assays to detect and report incidence of ADA."}
  • {"endpoint_text":"- Safety (type, incidence, severity, seriousness, and relatedness of adverse events [AEs]. Type, incidence, and severity of laboratory abnormalities as well as significant changes from baseline. Frequency of treatment interruptions, dose reductions, and treatment discontinuation due to AEs).","definition_or_measurement_approach":"Adverse event reporting, laboratory monitoring and recording of treatment modifications and discontinuations due to AEs."}

Recruitment

Digital Remote Recruitment
True; recruitment materials explicitly include paid search keywords, Facebook page, landing page, study page, image library, patient digital media board and homepage tiles; country-specific versions available (DE, IT, ES, and OUS/EN variants).
Planned Sample Size
64
Recruitment Window Months
29
Consent Approach
Informed consent obtained from participants (adults). Subject information and informed consent forms (Main ICD and optional procedure ICDs) are present and available in multiple language versions (German, Italian, Spanish and English versions of documents are listed). Recruitment informed consent procedure documents are provided per country. No assent procedures for minors are indicated.

Methods

  • Study-specific web pages / study landing pages (Study Page, Landing Page) — digital study pages for participant information (materials available in DE, EN, IT, ES and OUS variants).
  • Paid search keywords / patient paid search — paid search advertising to reach potential participants.
  • Social media (OUS Facebook Page) — use of Facebook pages for outreach and recruitment.
  • Patient digital media and image libraries / homepage tiles — digital media assets for websites and online adverts.
  • Patient digital media board and digital advertising materials — patient-facing digital content for outreach.
  • Printed recruitment material and participant-facing recruitment material (creation, printing and shipping) — vendor-supported physical materials.

Geography

Total Number Of Sites
21
Total Number Of Participants
26

Germany

Earliest CTIS Part Ii Submission Date
24-10-2025
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
187
Number Of Sites
5
Number Of Participants
8

Sites

Site Name
Universitaetsklinikum Leipzig AöR
Department Name
Universitäres Krebszentrum Leipzig (UCCL)
Contact Person Name
Dirk Forstmeyer
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Campus Mitte, Klinik fuer Gynaekologie m. S. Senologie
Contact Person Name
Verena Kiver
Contact Person Email
verena.kiver@charite.de
Site Name
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung, Klinik für Senologie/ Brustzentrum
Contact Person Name
Sherko Kümmel
Contact Person Email
s.kuemmel@kem-med.com
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Theresa Link
Site Name
Universitaetsklinikum Heidelberg AöR
Contact Person Name
Carlo Fremd

Italy

Earliest CTIS Part Ii Submission Date
01-10-2025
Latest Decision Or Authorization Date
22-04-2026
Processing Time Days
203
Number Of Sites
8
Number Of Participants
10

Sites

Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
Centro Ricerca Fase 1
Contact Person Name
Maria Elena Cazzaniga
Site Name
Universita Cattolica Del Sacro Cuore
Department Name
Unità operativa semplice di dipartimento Medicina di Precisione in Senologia
Contact Person Name
Alessandra Fabi
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Medical Oncology and Haematology
Contact Person Name
Claudio Zamagni
Contact Person Email
claudio.zamagni@aosp.bo.it
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
+390434659253
Contact Person Name
Fabio Puglisi
Contact Person Email
fabio.puglisi@cro.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
S.C. Oncologia Clinica Sperimentale di Senologia
Contact Person Name
Michelino De Laurentiis
Contact Person Email
delauren@breastunit.org
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Complex Structure in Medical Oncology
Contact Person Name
Antonino Musolino
Contact Person Email
antonino.musolino@irst.emr.it
Site Name
Azienda Unita' Sanitaria Locale Toscana Nord Ovest
Department Name
UOC Oncologia Medica di Livorno
Contact Person Name
Giacomo Allegrini
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Medical Oncology and Haematology
Contact Person Name
Claudio Zamagni
Contact Person Email
claudio.zamagni@aosp.bo.it

Spain

Earliest CTIS Part Ii Submission Date
24-10-2025
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
187
Number Of Sites
8
Number Of Participants
8

Sites

Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Oncology
Contact Person Name
Ana Godoy Ortiz
Contact Person Email
anagodort@gmail.com
Site Name
Hospital Del Mar
Department Name
Oncology
Contact Person Name
Sònia Servitja Tormo
Contact Person Email
sservitja@parcdesalutmar.cat
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
Cristina Saura
Contact Person Email
Csaura@vhio.net
Site Name
Hospital Universitario La Paz
Department Name
Oncology
Contact Person Name
Virginia Martinez Marin
Contact Person Email
virgimarin9@hotmail.com
Site Name
Hospital Beata Maria Ana
Department Name
Oncology
Contact Person Name
Javier Cortes Castán
Contact Person Email
Javier.cortes@maj3.health
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncology
Contact Person Name
Begoña Bermejo de las Heras
Contact Person Email
begobermejo@gmail.com
Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
Oncology
Contact Person Name
Encarnacion Gonzalez Flores
Site Name
Hospital Universitario La Paz
Department Name
Oncology
Contact Person Name
Virginia Martinez Marin
Contact Person Email
virgimarin9@hotmail.com

Sponsor

Primary sponsor

Full Name
Pfizer Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
training
Name
PPD Development LP / PPD Global Central Labs
Responsibilities
lab samples reception and storage; other trial support

Third parties

  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"training","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Professional Case Management Clinical Trials LLC","duties_or_roles":"home health services","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"lab samples reception and storage","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Q Squared Solutions Holdings LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"CRC support","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"lab sample biobank","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Innovative Trials Limited","duties_or_roles":"printing and shipping of participant and site facing recruitment material","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"participant reimbursement vendor","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Stark Raving LLC","duties_or_roles":"creation of participant and site facing recruitment material","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
Disitamab Vedotin
Active Substance
DISITAMAB VEDOTIN
Modality
ADC
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS

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