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Pembrolizumab

Phase 2

Triple Negative Breast Cancer | Small molecule | Oncology |Inhibrx Biosciences, Inc.|Last Updated: Jan 15, 2026

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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical trial landscape

Pembrolizumab · 1 trial · 1 indication

Phase 2 1
NCT06353997Neoadjuvant INBRX-106 in Combination With Pembrolizumab for Stage II/III TNBC PatientsTriple Negative Breast Cancer
RECRUITING12 Analytics
PHASE2RECRUITING
Neoadjuvant INBRX-106 in Combination With Pembrolizumab for Stage II/III TNBC Patients
Triple Negative Breast CancerUnlock trial analytics
Study Endpoints
Primary Endpoints
Volumetric Response
At the end of Cycle 2 (each cycle is 21 days)

Patients achieving (\>30%) reduction in ultrasound estimate of breast mass volume (mL) at the end of 2 cycles investigational therapy

Secondary Endpoints
Pathological response (following extended INBRX-106 + pembrolizumab)
30 days from last dose of study treatment
Pathological response (post-chemotherapy)
30 days from last dose of study treatment
IO-path response assessed prior to Cycle 2
Day 21
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Pembrolizumab + INBRX-106EXPERIMENTALPatients will be given pembrolizumab at a dose of 200mg IV in combination with INBRX-106 at a dose of 0.1mg/kg IV every 3 weeks.
Interventions
NameTypeDescription
PembrolizumabDRUGDrug will be delivered per standard-of-care as established by trial Keynote-522.
INBRX-106DRUGINBRX-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.
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: 1. Age ≥ 18 years, inclusive of all genders. 2. Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 2. 3. Patients must have histologically confirmed TNBC (ER/PR ≤ 10% allowed, HER2- as defined by ASCO guidelines). HER2 negative permitted to enroll ...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06353997primaryCompletionDate: changed
LOWMay 24, 2026NCT06353997studyFirstPostDate: changed