Actively Recruiting
Neoadjuvant INBRX-106 in Combination With Pembrolizumab for Stage II/III TNBC Patients
Led by Providence Health & Services · Updated on 2026-01-15
12
Participants Needed
4
Research Sites
247 weeks
Total Duration
On this page
Sponsors
P
Providence Health & Services
Lead Sponsor
I
Inhibrx Biosciences, Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a Phase II trial to assess efficacy and feasibility of pembrolizumab + INBRX-106 as an induction therapy preceding neoadjuvant therapy.
CONDITIONS
Official Title
Neoadjuvant INBRX-106 in Combination With Pembrolizumab for Stage II/III TNBC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, inclusive of all genders
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2
- Histologically confirmed triple-negative breast cancer with ER/PR 64 10%, HER2-negative as per ASCO guidelines
- Primary breast tumor measurable by ultrasound and at least 1 cm in size
- Clinically appropriate for neoadjuvant pembrolizumab plus chemotherapy planned for curative intent
- Multifocal or multicentric disease allowed; suspicious sites may require biopsy
- No prior therapy for triple-negative breast cancer
- Willingness to undergo serial ultrasounds, biopsies, and blood draws
- Adequate organ function as defined by specific blood count and chemistry thresholds within 28 days prior to treatment
- Fertile males and females of childbearing potential must agree to use highly effective contraception starting 28 days before treatment until 4 months after last dose
- Women of childbearing potential must have a negative pregnancy test within 72 hours prior to treatment start
- Tumor must have a stromal tumor infiltrating lymphocytes (sTILs) score of at least 1% on diagnostic biopsy
You will not qualify if you...
- Bilateral breast cancer
- Prior malignancies requiring ongoing active therapy or with significant risk of systemic recurrence
- Suspicion or confirmation of metastatic disease
- Primary tumor causing skin ulceration, chest wall invasion, or pain suggesting rapid progression
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PDL2, or other immune checkpoint agents within 3 years unless clinically appropriate
- Known allergy or hypersensitivity to study drugs or excipients
- Immunodeficiency or recent systemic steroid or immunosuppressive therapy exceeding defined doses
- Receipt of live vaccines within 30 days prior to study drug start
- Requirement for systemic corticosteroids or immunosuppressive medications within 14 days prior to study drug
- Psychiatric or substance abuse disorders interfering with study cooperation
- Pregnancy or breastfeeding
- History of pneumonitis requiring steroids or current pneumonitis
- History of allogenic tissue or solid organ transplantation
- Active autoimmune disease requiring systemic treatment exceeding prednisone 10 mg daily in past 2 years
- Known additional malignancy progressing or requiring systemic treatment in past 3 years except certain skin or carcinoma in situ
- Conditions or laboratory abnormalities that could interfere with study participation
- Active infection requiring systemic therapy except UTI or prophylactic antiviral treatment
- Known HIV infection
- Known active Hepatitis B or C infection
- History of active tuberculosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Ellison Institute of Technology (EITM)
Los Angeles, California, United States, 90064
Actively Recruiting
2
Providence Portland Cancer Institute - Franz Clinic
Portland, Oregon, United States, 97213
Actively Recruiting
3
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
Actively Recruiting
4
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Not Yet Recruiting
Research Team
N
Nicole Moxon, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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