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Pembrolizumab

Phase 2

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

Target and mechanism

Molecular targetPDCD1
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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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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Frequently asked questions about Pembrolizumab

What is Pembrolizumab used for in Triple Negative Breast Cancer?

Pembrolizumab is being studied in combination with INBRX-106 as a neoadjuvant treatment for patients with Stage II/III Triple Negative Breast Cancer (TNBC). The therapy is administered before surgery to assess its effect on the tumor. This is an investigational use, and pembrolizumab is not approved for this specific indication.

What does Pembrolizumab target?

Pembrolizumab targets PDCD1, which encodes the programmed cell death protein 1 (PD-1) receptor. As an inhibitor of PDCD1, it blocks the PD-1 pathway, which can help the immune system recognize and attack cancer cells. This mechanism is relevant to its use in oncology, including the ongoing trial in Triple Negative Breast Cancer.

Who makes Pembrolizumab?

Pembrolizumab is being developed by Inhibrx Biosciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol INBX. The company is conducting a Phase 2 clinical trial evaluating pembrolizumab in combination with INBRX-106 for the treatment of Triple Negative Breast Cancer.

What phase is Pembrolizumab in for Triple Negative Breast Cancer?

Pembrolizumab is in Phase 2 clinical development for Triple Negative Breast Cancer. The ongoing trial, NCT06353997, is currently recruiting participants in the United States. Pembrolizumab is an investigational agent for this indication and has not yet received FDA approval for this use.

What clinical trials is Pembrolizumab in?

Pembrolizumab is being evaluated in a single Phase 2 clinical trial with the identifier NCT06353997. The trial is titled "Neoadjuvant INBRX-106 in Combination With Pembrolizumab for Stage II/III TNBC Patients" and is currently recruiting. The study is enrolling 12 participants aged 18 years and older in the United States.

Is Pembrolizumab the same as pembrolizumab 200 mg?

Yes, pembrolizumab 200 mg refers to the same drug, pembrolizumab. The 200 mg designation indicates the specific dose being studied in the clinical trial. In the context of this trial, pembrolizumab is administered at a 200 mg dose in combination with INBRX-106 for the treatment of Triple Negative Breast Cancer.