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INBRX-106 with Pembrolizumab for Stage II/III Triple-Negative Breast Cancer

This study is testing a combination of two drugs, INBRX-106 and pembrolizumab, for patients with Stage II or III triple-negative breast cancer (TNBC). Pembrolizumab is a standard treatment, and INBRX-106 is a new drug that targets the OX40 receptor on cells. The study aims to see how well this combination shrinks tumors before other treatments. Researchers will measure tumor size after two cycles (each 21 days long) to see if the treatment is working. To join, you must be at least 18 years old, have a good general health status, and have triple-negative breast cancer that is HER2-negative. The study plans to enroll 12 participants, but the current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 12 participants. It uses a Simon 2-stage design, meaning it will first test the treatment in a small group before potentially expanding.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Tumor response is measured at the end of Cycle 2 (42 days after starting treatment).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06353997

Neoadjuvant INBRX-106 in Combination With Pembrolizumab for Stage II/III TNBC Patients

Recruiting
PHASE2Ages 18+InterventionalTreatment
Providence Health & Services
~12 participants
Updated 2026-09-16 on ClinicalTrials.gov
What's tested:PembrolizumabINBRX-106

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Volumetric Response
Measured over At the end of Cycle 2 (each cycle is 21 days)

Conditions

Triple Negative Breast Cancer

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NCT06353997

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Ellison Institute of Technology (EITM)

    Los Angeles, Californiastudy coordinator listed

    Recruiting

  • Providence Portland Cancer Institute - Franz Clinic

    Portland, Oregonstudy coordinator listed

    Recruiting

  • Providence St. Vincent Medical Center

    Portland, Oregonstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • David Page, MD · PRINCIPAL_INVESTIGATOR · Providence Health & Services

Who to contact

Nicole Moxon, RN
[email protected]
503-215-1979
Email the study team

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Eligibility criteria

Inclusion

Absolute neutrophil count (ANC) ≥1500/µL
Platelets ≥100 000/µL
Hemoglobin ≥8.0 g/dL or ≥5.0 mmol/L
Creatinine OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL/min for participant with creatinine levels \>1.5 × institutional ULN
Total bilirubin ≤1.5 × ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \>1.5 × ULN. Patients with elevated LFTs that are suggestive of Gilbert's disease (a benign process) are eligible.
AST (SGOT) and ALT (SGPT) ≤2.5 × ULN
International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
TSH and free T4 levels: Patients must have adequate thyroid function as demonstrated by free T4 values, regardless of TSH. 10. Fertile male patients and female patients of childbearing potential must agree to avoid impregnating a partner or becoming pregnant, respectively. They must be willing to employ highly effective contraception methods (with a failure rate of less than 1% when used consistently and correctly) at least 28 days before the first dose of study treatment until 4 months after the last dose of study treatment.
Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: Oral. Intravaginal. Transdermal.
Progestogen-only hormonal contraception associated with inhibition of ovulation: Oral. Injectable. Implantable.
Intrauterine device (IUD).
Intrauterine hormone-releasing system (IUS).
Bilateral tubal occlusion.
Vasectomized partner. (Only considered to be highly effective contraception if he is the sole sexual partner of the female patient of childbearing potential and if the vasectomized partner has received medical assessment of the surgical success.)
Sexual abstinence. (Only considered to be highly effective contraception if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient and if considered acceptable by local regulatory agencies and IRBs/IECs. 11. WOCBP must have a negative urinary or serum pregnancy test within 72 hours prior to start of treatment. If screening serum pregnancy test collected outside of 72 hours prior to start of treatment, this may be accepted for determination of eligibility but must be re-checked prior to treatment C1D1. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. The following age-specific requirements apply:

What this trial measures

  • Volumetric ResponseAt 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