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.
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
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There are 15 Locations for this study
Newark Delaware, 19713, United States
Jacksonville Florida, 32224, United States
Silver Spring Maryland, 20904, United States
Albany New York, 12206, United States
Columbus Ohio, 43212, United States
Monroeville Pennsylvania, 15146, United States
Charleston South Carolina, 29414, United States
Germantown Tennessee, 38138, United States
Austin Texas, 78731, United States
Dallas Texas, 75230, United States
Plano Texas, 75075, United States
San Antonio Texas, 78240, United States
Tyler Texas, 75702, United States
Fairfax Virginia, 22031, United States
Norfolk Virginia, 23502, United States
Brussel , , Belgium
Leuven , , Belgium
Mechelen , , Belgium
Caen Cedex 05 , , France
Lyon , , France
Nantes cedex 2 , , France
Paris , , France
Plérin , , France
Saint-cloud , , France
Milano , , Italy
Milano , , Italy
Napoli , , Italy
Padova , , Italy
Pisa , , Italy
Roma , , Italy
Rozzano , , Italy
Arkhangelsk , , Russian Federation
Krasnodar , , Russian Federation
Krasnodar , , Russian Federation
Moscow , , Russian Federation
Omsk , , Russian Federation
Pyatigorsk , , Russian Federation
Saint Petersburg , , Russian Federation
Tomsk , , Russian Federation
Ufa , , Russian Federation
Cordoba , , Spain
Madrid , , Spain
Madrid , , Spain
Madrid , , Spain
Sevilla , , Spain
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