This is a Phase II trial to assess efficacy and feasibility of pembrolizumab + INBRX-106 as an induction therapy preceding neoadjuvant therapy.
Age ≥ 18 years, inclusive of all genders.
Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 2.
Patients must have histologically confirmed TNBC (ER/PR ≤ 10% allowed, HER2- as defined by ASCO guidelines). HER2 negative permitted to enroll as IHC 0, 1, or 2+ with negative ISH.
Primary breast tumor measurable by ultrasound and at least 1cm.
Bilateral breast cancer.
Prior malignancies that require ongoing active therapy or are at clinically significant risk of systemic recurrence in the opinion of the investigator.
Suspicion for, or histologically confirmed, metastatic disease.
Primary tumor with potential for skin ulceration or invasion of the chest wall, or with pain that would suggest rapid progression or imminent muscle/skin involvement in the opinion of the enrolling investigator.
Providence Health & Services
Lead sponsor
Inhibrx Biosciences, Inc
Collaborator