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BREAST: TNBC: HMGA2 high(prescreening): > or = 2nd line: MS200647_0020: :

A Phase II, Multicenter, Open Label Study of Bintrafusp Alfa (M7824) Monotherapy in Participants With HMGA2-expressing Triple Negative Breast Cancer

Title
EMD Serono (Breast TNBC, HMGA2 overexpressing)
Study Title

A Phase II, Multicenter, Open Label Study of Bintrafusp Alfa (M7824) Monotherapy in Participants With HMGA2-expressing Triple Negative Breast Cancer

Site Link
Malignancy
Breast, triple negative breast cancer, TNBC
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
2nd line or greater
Investigational Agent
Bintrafusp alfa
Drug Class
Bifunctional fusion protein, anti-PD-L1 + TGF-beta trap
PI
Greg Vidal, MD, PhD
Sponsor
EMD Serono Research and Development Institute
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Histologically or cytologically confirmed TNBC
  • At least 1 line of systemic therapy for metastaic disease and have progressed on line of therapy immediately prior to study entry
  • May screen for HMGA2 during preceding treatment, but should only occur if MD thinks progression will occur within 6 months
  • Measurable disease
  • Availability of archival tumor tissue, fresh core, or excisional biopsy to determine HMGA2 expression prior to enrollment
  • ECOG PS 0-1
  • HIV, HBV, HCV are eligible
  • No active CNS metastases causing clinical symptoms
  • No prior immunotherapy or checkpoint inhibitor therapy
  • No active autoimmune disease
Objective
  • Primary
    • ORR
  • Secondary
    • DOR
    • PFS
    • Durable response rate
    • OS
    • Safety
    • PK
Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
ER - (negative), PR - (negative), HER2 - (negative), HMGA2 overexpressing
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
X