Breast Cancer Clinical Trial

Bintrafusp Alfa in High Mobility Group AT-Hook 2 (HMGA2) Expressing Triple Negative Breast Cancer

Summary

The main purpose of this study is to evaluate bintrafusp alfa monotherapy in participants with triple negative breast cancer (TNBC) who express high levels of HMGA2 as determined by a centralized reverse transcriptase-polymerase chain reaction (RT-PCR) test.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Study participants have histologically or cytologically confirmed TNBC
Absence of human epidermal growth factor receptor 2 (HER2), estrogen receptor, and progesterone receptor expression must be documented (criteria for defining TNBC are outlined in the protocol)
Participants must have received at least one line of systemic therapy for metastatic disease and have progressed on the line of therapy immediately prior to study entry. There is no limit to the number of prior therapies
Participants may prescreen for HMGA2 expression while on preceding treatment, however screening should only occur if in the opinion of the Investigator, the participant would likely be eligible for study within 6 months
Participants must have measurable disease
Availability of either archival tumor tissue or fresh core or excisional biopsy of a tumor lesion (primary or metastatic, excluding bone biopsies) is mandatory to determine HMGA2 expression level prior to enrollment
HMGA2 high tumor expression is required and will be determined by a central lab
Participants who have Eastern Cooperative Oncology Group (ECOG) PS of 0 to 1
Participants have a life expectancy greater than or equal to (>=) 12 weeks as judged by the Investigator at study start
Participants have adequate hematological, hepatic and renal and coagulation function as defined in the protocol
Participants with known Human Immunodeficiency Virus (HIV) infections are in general eligible if the criteria as defined in the protocol are met (Food and Drug Administration [FDA] Guidance on Cancer Clinical Trial Eligibility, March 2019)
Participants with hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infections are in general eligible if the criteria as defined in the protocol are met (FDA Guidance on Cancer Clinical Trial Eligibility, March 2019)
Other protocol defined inclusion criteria could apply

Exclusion Criteria:

Participants with active central nervous system (CNS) metastases causing clinical symptoms or metastases that require therapeutic intervention are excluded. Participants with a history of treated CNS metastases (by surgery or radiation therapy) are not eligible unless they have fully recovered from treatment, demonstrated no progression for at least 4 weeks, and are not using steroids for at least 7 days prior to the start of study intervention
Participants must not have received prior cancer treatment with any other immunotherapy or checkpoint inhibitors, or any other immune-modulating monoclonal antibody
Participants that received any organ transplantation, including stem-cell transplantation, but with the exception of transplants that do not require immunosuppression
Participants with significant acute or chronic infections
Participants with active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
Participants with clinically significant cardiovascular/cerebrovascular disease including: cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure, or serious cardiac arrhythmia
Other protocol defined exclusion criteria could apply

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

11

Study ID:

NCT04489940

Recruitment Status:

Completed

Sponsor:

EMD Serono Research & Development Institute, Inc.

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There are 15 Locations for this study

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Medical Oncology Hematology Consultants, PA, Helen F. Graham Cancer Center, Suite 3400
Newark Delaware, 19713, United States
Mayo Clinic-Jacksonville
Jacksonville Florida, 32224, United States
Maryland Oncology Hematology, P.A.
Silver Spring Maryland, 20904, United States
New York Oncology Hematology, P.C. - Albany
Albany New York, 12206, United States
TheOhio State University, Stefanie Spielman Comprehensive Breast Center
Columbus Ohio, 43212, United States
UPMC Hillman Cancer Center - Hillman Cancer Center
Monroeville Pennsylvania, 15146, United States
Charleston Hematology Oncology Associates, PA
Charleston South Carolina, 29414, United States
The West Clinic
Germantown Tennessee, 38138, United States
Texas Oncology, P.A. - Austin - Austin Central Cancer Center
Austin Texas, 78731, United States
Texas Oncology, P.A. - Medical City Dallas - Pediatric Hematology/Oncology
Dallas Texas, 75230, United States
Texas Oncology, P.A. - Plano
Plano Texas, 75075, United States
Texas Oncology-San Antonio Stone Oak
San Antonio Texas, 78240, United States
Texas Oncology, P.A. - Tyler
Tyler Texas, 75702, United States
Virginia Cancer Specialists
Fairfax Virginia, 22031, United States
Virginia Oncology Associates - Hampton
Norfolk Virginia, 23502, United States
Universitair Ziekenhuis Brussel - Geriatrie
Brussel , , Belgium
UZ Leuven
Leuven , , Belgium
AZ Sint-Maarten - PARENT
Mechelen , , Belgium
Centre François Baclesse - Pathologies Gynecologiques
Caen Cedex 05 , , France
Centre Léon Bérard
Lyon , , France
Hôpital Privé du Confluent SAS
Nantes cedex 2 , , France
Groupe Hospitalier Diaconesses - Hôpital De La Croix Saint Simon - service d'oncologie medicale
Paris , , France
CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie
Plérin , , France
Institut Curie - Centre René Huguenin - Service d'Oncologie Médicale
Saint-cloud , , France
IEO Istituto Europeo di Oncologia
Milano , , Italy
Ospedale San Raffaele
Milano , , Italy
Istituto Nazionale Tumori Fondazione G. Pascale - Dipartimento di Senologia
Napoli , , Italy
IOV - Istituto Oncologico Veneto IRCCS - Oncologia Medica 2
Padova , , Italy
Azienda Ospedaliero Universitaria Pisana - U.O. Oncologia II
Pisa , , Italy
Policlinico Universitario Agostino Gemelli - UOC Oncologia Medica
Roma , , Italy
Istituto Clinico Humanitas
Rozzano , , Italy
SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary" - Chemotherapy
Arkhangelsk , , Russian Federation
SBIH " Clinical Oncological Dispensary # 1" - Location
Krasnodar , , Russian Federation
SBIH " Clinical Oncological Dispensary 1" - Location
Krasnodar , , Russian Federation
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin" - Moscow Cancer Research Centre
Moscow , , Russian Federation
BHI of Omsk region "Clinical Oncology Dispensary"
Omsk , , Russian Federation
LLC "ClinicaUZI4D"
Pyatigorsk , , Russian Federation
FSBI "Clinical Research and Practical Center for specialized medical care (oncology)"
Saint Petersburg , , Russian Federation
Tomsk Research Instutite of Oncology - Chemotherapy
Tomsk , , Russian Federation
SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan
Ufa , , Russian Federation
Hospital Universitario Reina Sofia - Dept of Oncology
Cordoba , , Spain
Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica
Madrid , , Spain
Hospital Ruber Internacional - Servicio de Oncologia
Madrid , , Spain
Hospital Universitario Ramon y Cajal - Servicio de Oncologia
Madrid , , Spain
Hospital Universitario Virgen del Rocio - Servicio de Oncologia
Sevilla , , Spain

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

11

Study ID:

NCT04489940

Recruitment Status:

Completed

Sponsor:


EMD Serono Research & Development Institute, Inc.

How clear is this clinincal trial information?

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