West Cancer Center

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 MS200647_0020 (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

NCT04489940

Malignancy

Breast, triple negative breast cancer, TNBC

Stage

Stage 4

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

Greg Vidal, MD, PhD

Sponsor

EMD Serono Research and Development Institute

Phase

Phase 2

Status

Closed to Accrual

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

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

ER - (negative), PR - (negative), HER2 - (negative), HMGA2 overexpressing

Dosing Frequency

Control Agents

Study Protocol

Randomized