Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
90
Countries
3
Sites
19
HER2 Expressing Advanced Breast Cancer
To estimate the antitumor activity of disitamab vedotin in: - HER2+ advanced BC in post trastuzumab deruxtecan (T-DXd; Enhertu) setting - Hormone receptor (HR)+/HER2-low advanced BC in post T-DXd setting - HR+/HER2-ultralow advanced BC - HR-/HER2-low (HER2-low triple-negative BC [TNBC]) advanced BC
Key facts
- Sponsor
- Pfizer Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 19 Dec 2025 → ongoing
- Decision date (initial)
- 2025-11-21
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-521003-52-00
- ClinicalTrials.gov
- NCT06966453
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Others
To estimate the antitumor activity of disitamab vedotin in:
- HER2+ advanced BC in post trastuzumab deruxtecan (T-DXd; Enhertu) setting
- Hormone receptor (HR)+/HER2-low advanced BC in post T-DXd setting
- HR+/HER2-ultralow advanced BC
- HR-/HER2-low (HER2-low triple-negative BC [TNBC]) advanced BC
Secondary objectives 4
- To estimate the antitumor activity of disitamab vedotin in: 1) HER2+ advanced BC in post T-DXd (Enhertu) setting 2) HR+/HER2-low advanced BC in post T-DXd setting 3) HR+/HER2-ultralow advanced BC 4) HR-/HER2-low (HER2-low triple-negative BC [TNBC]) advanced BC
- To evaluate the pharmacokinetics (PK) of disitamab vedotin, total antibody, and unconjugated monomethyl auristatin E (MMAE)
- To characterize the immunogenicity of disitamab vedotin
- To characterize the safety of disitamab vedotin in advanced BC.
Conditions and MedDRA coding
HER2 Expressing Advanced Breast Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 28.0 | PT | 10089162 | HER2 low breast cancer | 100000004864 |
| 27.0 | LLT | 10027475 | Metastatic breast cancer | 10029104 |
| 28.0 | PT | 10092021 | HER2 ultralow breast cancer | 100000004864 |
| 21.1 | LLT | 10072737 | Advanced breast cancer | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Histologically or cytologically confirmed diagnosis of locally-advanced, unresectable, or metastatic breast carcinoma.
- HER2 and 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.
- 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 5
- Known hypersensitivity to any excipient contained in the drug formulation of disitamab vedotin.
- 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.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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.
Secondary endpoints 7
- Duration of response (DOR) per RECIST v1.1 by investigator assessment.
- Disease control rate (DCR) (confirmed CR, confirmed PR, and stable disease) per RECIST v1.1 by investigator assessment.
- Progression-free survival (PFS) per RECIST v1.1 by investigator assessment.
- Overall survival (OS).
- Estimates of selected PK parameters of disitamab vedotin, total antibody, and unconjugated MMAE.
- Incidence of anti-drug antibodies (ADA) against disitamab vedotin.
- 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).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD9442609 · Product
- Active substance
- Disitamab Vedotin
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Authorisation status
- Not Authorised
- MA holder
- SEATTLE GENETICS INC
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pfizer Inc.
- Sponsor organisation
- Pfizer Inc.
- Address
- 66 Hudson Boulevard East
- City
- New York
- Postcode
- 10001-2189
- Country
- United States
Scientific contact point
- Organisation
- Pfizer Inc.
- Contact name
- Clinical Medical Lead
Public contact point
- Organisation
- Pfizer Inc.
- Contact name
- Clinical Medical Lead
Third parties 15
| Organisation | City, country | Duties |
|---|---|---|
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
| Professional Case Management Clinical Trials LLC ORG-100044408
|
Denver, United States | Other |
| PPD Global Central Labs ORG-100046496
|
Zaventem, Belgium | Other |
| Frontage Laboratories Inc. ORG-100011515
|
Exton, United States | Laboratory analysis |
| Q Squared Solutions Holdings LLC ORG-100043288
|
Durham, United States | Laboratory analysis |
| CellCarta ORG-100039881
|
Antwerp, Belgium | Laboratory analysis |
| Almac Clinical Services Limited ORG-100017464
|
Craigavon, United Kingdom (Northern Ireland) | Code 14 |
| WCG Clinical Inc. ORG-100040730
|
Princeton, United States | Other |
| Guardant Health Inc. ORG-100042461
|
Redwood City, United States | Laboratory analysis |
| PPD Development LP ORG-100011560
|
Richmond, United States | Laboratory analysis |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| Azenta US Inc. ORG-100012907
|
South Plainfield, United States | Other |
| Innovative Trials Limited ORG-100044081
|
Letchworth Garden City, United Kingdom | Other |
| Scout Clinical ORG-100042228
|
Dallas, United States | Other |
| Stark Raving LLC ORG-100049498
|
Boston, United States | Other |
Locations
3 EU/EEA countries · 19 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 8 | 5 |
| Italy | Ongoing, recruiting | 10 | 7 |
| Spain | Ongoing, recruiting | 8 | 7 |
| Rest of world
Puerto Rico, United States, Canada, Brazil, Australia, Japan
|
— | 64 | — |
Investigational sites
KEM I Evang. Kliniken Essen-Mitte gGmbH
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung, Klinik für Senologie/ Brustzentrum, Henricistrasse 92, Huttrop, Essen
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsklinikum Leipzig AöR
Universitäres Krebszentrum Leipzig (UCCL), Liebigstrasse 20, Zentrum-Suedost, Leipzig
Charite Universitaetsmedizin Berlin KöR
Campus Mitte, Klinik fuer Gynaekologie m. S. Senologie, Chariteplatz 1, Mitte, Berlin
Universitaetsklinikum Heidelberg AöR
N/A, Im Neuenheimer Feld 460, Neuenheim, Heidelberg
Centro Di Riferimento Oncologico Di Aviano
+390434659253, Via Franco Gallini 2, 33081, Aviano
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Complex Structure in Medical Oncology, Via Piero Maroncelli 40, 47014, Meldola
IRCCS Istituto Nazionale Tumori Fondazione Pascale
S.C. Oncologia Clinica Sperimentale di Senologia, Via Mariano Semmola 52, 80131, Naples
Fondazione IRCCS San Gerardo Dei Tintori
Centro Ricerca Fase 1, Via Giovanni Battista Pergolesi 33, 20900, Monza
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Medical Oncology and Haematology, Via Pietro Albertoni 15, 40138, Bologna
Azienda Unita' Sanitaria Locale Toscana Nord Ovest
UOC Oncologia Medica di Livorno, Viale Vittorio Alfieri 36, 57124, Leghorn
Universita Cattolica Del Sacro Cuore
Unità operativa semplice di dipartimento Medicina di Precisione in Senologia, Largo Agostino Gemelli 8, 00168, Rome
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Del Mar
Oncology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitario Virgen De Las Nieves
Oncology, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Hospital Beata Maria Ana
Oncology, Calle Del Doctor Esquerdo No. 83, 28007, Madrid
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Virgen De La Victoria
Oncology, Campus De Teatinos Sn, Puerto De La Torre, Malaga
Hospital Universitario La Paz
Oncology, Paseo De La Castellana 261, 28046, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2026-02-12 | 2026-03-26 | |||
| Italy | 2025-12-31 | 2026-01-14 | |||
| Spain | 2025-12-19 | 2026-01-07 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 73 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2025-521003-52-00_C5731006_EN_Protocol_public | PA1 |
| Protocol (for publication) | D3_PACL_PPQ lots PA1 2025-521003-52-00_C5731006_EN_public | NA |
| Protocol (for publication) | D3_PACL_Prior Therapy_2025-521003-52-00_C5731006_EN_public | NA |
| Protocol (for publication) | D4_Patient-facing material linked to endpoints_2025-521003-52-00_C5731006_EN_copyright | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_C5731006_DE_EN_Public | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Informed Consent Procedure_C5731006_ES_EN_Public | 1 |
| Recruitment arrangements (for publication) | K10_Recruitment material_Study Page_C5731006_DE_EN_Public | 1 |
| Recruitment arrangements (for publication) | K10_Recruitment material_Study Page_C5731006_ES_EN_Public | 1 |
| Recruitment arrangements (for publication) | K10_Recruitment material_Study Page_C5731006_IT_EN_Public | 1 |
| Recruitment arrangements (for publication) | K11_Recruitment material_Clinical Trials_C5731006_DE_DE_Public | 2 |
| Recruitment arrangements (for publication) | K11_Recruitment material_Clinical Trials_C5731006_ES_ES_Public | 1 |
| Recruitment arrangements (for publication) | K11_Recruitment material_Clinical Trials_C5731006_IT_IT_Public | 2 |
| Recruitment arrangements (for publication) | K12_Recruitment material_General FAQs_C5731006_DE_DE_Public | 2 |
| Recruitment arrangements (for publication) | K12_Recruitment material_General FAQs_C5731006_ES_ES_Public | 1 |
| Recruitment arrangements (for publication) | K12_Recruitment material_General FAQs_C5731006_IT_IT_Public | 2 |
| Recruitment arrangements (for publication) | K13_Recruitment material_Homepage_C5731006_DE_DE_Public | 1 |
| Recruitment arrangements (for publication) | K13_Recruitment material_Homepage_C5731006_ES_ES_Public | 1 |
| Recruitment arrangements (for publication) | K13_Recruitment material_Homepage_C5731006_IT_IT_Public | 2 |
| Recruitment arrangements (for publication) | K14_Recruitment material_Homepage Artwork_C5731006_DE_EN_Public | 2 |
| Recruitment arrangements (for publication) | K14_Recruitment material_Homepage Artwork_C5731006_ES_EN_Public | 2 |
| Recruitment arrangements (for publication) | K14_Recruitment material_Homepage Artwork_C5731006_IT_EN_Public | 2 |
| Recruitment arrangements (for publication) | K15_Recruitment material_Landing Page_C5731006_DE_EN_Public | 2 |
| Recruitment arrangements (for publication) | K15_Recruitment material_Landing Page_C5731006_ES_EN_Public | 2 |
| Recruitment arrangements (for publication) | K15_Recruitment material_Landing Page_C5731006_IT_EN_Public | 2 |
| Recruitment arrangements (for publication) | K16_Recruitment material_OUS Website Additional Imagery_C5731006_DE_EN_Public | 1 |
| Recruitment arrangements (for publication) | K16_Recruitment material_OUS Website Additional Imagery_C5731006_ES_EN_Public | 1 |
| Recruitment arrangements (for publication) | K16_Recruitment material_OUS Website Additional Imagery_C5731006_IT_EN_Public | 1 |
| Recruitment arrangements (for publication) | K17_Recruitment material_Privacy_C5731006_DE_DE_Public | 2 |
| Recruitment arrangements (for publication) | K17_Recruitment material_Privacy_C5731006_IT_IT_Public | 2 |
| Recruitment arrangements (for publication) | K17_Recruitment material_Privacy_ES ES_C5731006_ES_ES_Public | 1 |
| Recruitment arrangements (for publication) | K18_Recruitment material_Steps To Join_C5731006_DE_DE_Public | 2 |
| Recruitment arrangements (for publication) | K18_Recruitment material_Steps To Join_C5731006_ES_ES_Public | 1 |
| Recruitment arrangements (for publication) | K18_Recruitment material_Steps To Join_C5731006_IT_IT_Public | 2 |
| Recruitment arrangements (for publication) | K1a_Recruitment Informed Consent Procedure_C5731006_IT_EN_Public | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Study Brochure_C5731006_DE_DE_Public | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Study Brochure_C5731006_ES_ES_Public | 1 |
| Recruitment arrangements (for publication) | K2a_Recruitment Material_Study Brochure_C5731006_IT_IT_Public | 1.1 |
| Recruitment arrangements (for publication) | K3_Recruitment material_Patient Digital Media Board_C5731006_DE_DE_Public | 2 |
| Recruitment arrangements (for publication) | K3_Recruitment material_Patient Digital Media Board_C5731006_ES_ES_Public | 2 |
| Recruitment arrangements (for publication) | K3_Recruitment material_Patient Digital Media Board_C5731006_IT_IT_Public | 2 |
| Recruitment arrangements (for publication) | K4_Recruitment material_Patient Paid Search Keywords_C5731006_DE_EN_Public | 1 |
| Recruitment arrangements (for publication) | K4_Recruitment material_Patient Paid Search Keywords_C5731006_ES_EN_Public | 1 |
| Recruitment arrangements (for publication) | K4_Recruitment material_Patient Paid Search Keywords_C5731006_IT_EN_Public | 1 |
| Recruitment arrangements (for publication) | K5_Recruitment material_OUS Facebook Page_C5731006_DE_EN_Public | 1 |
| Recruitment arrangements (for publication) | K5_Recruitment material_OUS Facebook Page_C5731006_ES_EN_Public | 1 |
| Recruitment arrangements (for publication) | K5_Recruitment material_OUS Facebook Page_C5731006_IT_EN_Public | 1 |
| Recruitment arrangements (for publication) | K6_Recruitment material_Image Library_C5731006_DE_EN_Public | 1 |
| Recruitment arrangements (for publication) | K6_Recruitment material_Image Library_C5731006_ES_EN_Public | 1 |
| Recruitment arrangements (for publication) | K6_Recruitment material_Image Library_C5731006_IT_EN_Public | 1 |
| Recruitment arrangements (for publication) | K7_Recruitment material_Homepage Tiles_C5731006_DE_DE_Public | 1 |
| Recruitment arrangements (for publication) | K7_Recruitment material_Homepage Tiles_C5731006_ES_ES_Public | 1 |
| Recruitment arrangements (for publication) | K7_Recruitment material_Homepage Tiles_C5731006_IT_IT_Public | 1 |
| Recruitment arrangements (for publication) | K8_Recruitment material_Homepage Tiles_C5731006_DE_EN_Public | 1 |
| Recruitment arrangements (for publication) | K8_Recruitment material_Homepage Tiles_C5731006_ES_EN_Public | 1 |
| Recruitment arrangements (for publication) | K8_Recruitment material_Homepage Tiles_C5731006_IT_EN_Public | 1 |
| Recruitment arrangements (for publication) | K9_Recruitment material_Study Page_C5731006_DE_DE_Public | 1 |
| Recruitment arrangements (for publication) | K9_Recruitment material_Study Page_C5731006_ES_ES_Public | 1 |
| Recruitment arrangements (for publication) | K9_Recruitment material_Study Page_C5731006_IT_IT_Public | 1 |
| Subject information and informed consent form (for publication) | L1a_Main ICD_C5731006_ IT_IT_Public | NA |
| Subject information and informed consent form (for publication) | L1a_Main ICD_C5731006_DE_DE_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1a_Main_ICD_C5731006_ES_ES_Public | NA |
| Subject information and informed consent form (for publication) | L2_Optional RRS_ICD_C5731006_ES_ES_Public | NA |
| Subject information and informed consent form (for publication) | L2_Privacy Supplement_C5731006_IT_IT_Public | NA |
| Subject information and informed consent form (for publication) | L2a_Optional RRS ICD_C5731006_DE_DE_Public | NA |
| Subject information and informed consent form (for publication) | L3_Optional Procedure ICD_C5731006_IT_IT_Public | NA |
| Subject information and informed consent form (for publication) | L3_Optional Procedure_Biopsy_ICD_C5731006_ES_ES_Public | NA |
| Subject information and informed consent form (for publication) | L3a_Optional Procedure ICD_C5731006_DE_DE_Public | NA |
| Subject information and informed consent form (for publication) | L4_PPRIF_C5731006_ES_ES_Public | NA |
| Subject information and informed consent form (for publication) | L4_Scout ICD_C5731006_DE_DE_Public | 1.0 |
| Subject information and informed consent form (for publication) | L4_Scout_ICD_C5731006_IT_IT_Public | 3.0 |
| Subject information and informed consent form (for publication) | L5_Pregnant Partner Information Form_C5731006_IT_IT_Public | NA |
| Synopsis of the protocol (for publication) | D2_Protocol-Synopsis_2025-521003-52-00_C5731006_ES_public | PA1 |
| Synopsis of the protocol (for publication) | D2_Protocol-Synopsis_2025-521003-52-00_C5731006_IT_public | PA1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-30 | Italy | Acceptable 2025-11-17
|
2025-11-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-02-23 | Italy | Acceptable 2026-04-21
|
2026-04-22 |