Neoadjuvant INBRX-106 in Combination With Pembrolizumab for Stage II/III TNBC Patients
NCT06353997 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2026-01-15
Summary
This is a Phase II trial to assess efficacy and feasibility of pembrolizumab + INBRX-106 as an induction therapy preceding neoadjuvant therapy.
Conditions
Interventions
- DRUG
-
Drug will be delivered per standard-of-care as established by trial Keynote-522.
- DRUG
-
INBRX-106
INBRX-106 is a hexavalent, recombinant humanized IgG1, OX40 agonist antibody that targets the human OX40 receptor (TNFRSF4, UniProtKB: P43489). INBRX-106 is based on a sdAb platform and, in detail, 3 identical humanized camelid heavy chain-only antibody binding domains (VHHs) targeting OX40 are joined end-to-end and with an Fc based on human IgG1 to create a molecule that homo-dimerizes into an antibody targeting a total of 6 OX40 receptors.
Sponsors & Collaborators
-
Inhibrx Biosciences, Inc
collaborator INDUSTRY -
Providence Health & Services
lead OTHER
Principal Investigators
-
David Page, MD · Providence Health & Services
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-05
- Primary Completion
- 2027-06-30
- Completion
- 2029-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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