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

Merck KGaA (EMD Serono)

Status and phase

Terminated

Phase 2

Conditions

Triple Negative Breast Neoplasms

Treatments

Drug: Bintrafusp alfa

Study type

Interventional

Funder types

Industry

Identifiers

NCT04489940

2019-004833-18 (EudraCT Number)

MS200647_0020

Details and patient eligibility

About

The main purpose of this study was 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.

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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