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Triple Negative Breast CancerPhase 2NCT06353997

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

A Phase 2 study testing Pembrolizumab and INBRX-106 in people with Triple Negative Breast Cancer, run by Providence Health & Services at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a Phase II trial to assess efficacy and feasibility of pembrolizumab + INBRX-106 as an induction therapy preceding neoadjuvant therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Triple Negative Breast Cancer
What is being tested?
Pembrolizumab and INBRX-106
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
3 sitesUnited States
Study dates
5 Sep 2024to Jun 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years, inclusive of all genders.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 2.
  • Patients must have histologically confirmed TNBC (ER/PR ≤ 10% allowed, HER2- as defined by ASCO guidelines). HER2 negative permitted to enroll as IHC 0, 1, or 2+ with negative ISH.
  • Primary breast tumor measurable by ultrasound and at least 1cm.
  • Clinically appropriate to receive neoadjuvant pembrolizumab plus chemotherapy (e.g. Keynote-522) planned for curative intent per standard of care (as indicated following study therapy however not mandated on trial for Option 2).
  • Multifocal/multicentric disease is allowed. If clinically indicated per the standard of care, suspicious sites that do not appear to be part of the same disease process should be biopsied with reconfirmation of ER/PR/HER2 status. Up to 20 slides or 1 block may be submitted to conduct biomarkers studies on remaining tissue.
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  • No prior therapy of any kind for TNBC.
  • Willingness to undergo serial ultrasounds, serial biopsies, and blood draws.
  • Patients must have adequate organ function as defined below. Specimens must be collected within 28 days prior to the start of study treatment.
  • 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.
  • 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.
  • A woman is considered of childbearing potential following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. Postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
  • Acceptable methods of contraception presented below are in compliance with the Clinical Trial Facilitation and Coordination Group (CTFG) recommendations related to contraception and pregnancy testing in clinical trials, Version 1.1 (September, 2020). However, if a contraception method listed below is restricted by local regulations/guidelines, then it does not qualify as an acceptable method of contraception in that country/region. Local guidelines should be followed.
  • 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.
  • 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:
  • Women < 50 years of age are considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
  • Women ≥ 50 years of age are considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
  • To be eligible by H\&E, the tumor must have a stromal tumor infiltrating lymphocytes (sTILs) score of at least 1% on diagnostic biopsy as defined by the International TILs Working Group (https://www.tilsinbreastcancer.org/), ascertained by local pathologist or study pathologist.

Who cannot join

  • Bilateral breast cancer.
  • Prior malignancies that require ongoing active therapy or are at clinically significant risk of systemic recurrence in the opinion of the investigator.
  • Suspicion for, or histologically confirmed, metastatic disease.
  • Primary tumor with potential for skin ulceration or invasion of the chest wall, or with pain that would suggest rapid progression or imminent muscle/skin involvement in the opinion of the enrolling investigator.
  • Prior therapy with an anti-PD-1, anti-PD-L1, or antiPDL2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX40, CD137). Patients who have received these agents more than 3 years prior for other malignancies may be considered if they are not still at clinically significant risk of systemic recurrence in the opinion of the investigator.
  • Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
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  • Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
  • Received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
  • Additionally, COVID-19 vaccinations (including boosters) should not be scheduled within 72 hours (before or after) of dosing days for INBRX-106 and pembrolizumab.
  • Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Pregnant or breastfeeding.
  • History of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
  • History of allogenic tissue/solid organ transplantation.
  • Has active autoimmune disease that has required systemic treatment in excess of prednisone 10mg daily or equivalent in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Has a known additional malignancy (other than their current breast cancer diagnosis) that is progressing or has required active systemic treatment within the past 3 years.
  • Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
  • History or current evidence of any condition, therapy, or clinically significant laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Active infection requiring systemic therapy with the exception of UTI requiring oral antibiotic therapy and prophylactic anti-viral therapy (e.g. Acyclovir).
  • Known history of Human Immunodeficiency Virus (HIV) infection.
  • Known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Patients with naturally acquired immunity are allowed (i.e. HBsAg(-); HBcAb(+); HBsAb(+/-).
  • Any known history of active TB (Bacillus Tuberculosis).

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Nicole Moxon, RN contact

503-215-1979

canrsrchstudies@providence.org

United States3 sites, 3 recruiting

  • Ellison Institute of Technology (EITM)

    Los Angeles, California, 90064

    Reva Basho, MD, 310-272-7640

    Recruiting

  • Providence Portland Cancer Institute - Franz Clinic

    Portland, Oregon, 97213

    Nicole Moxon, RN, 503-215-1979, canrsrchstudies@providence.org

    Alison Conlin, MD

    Recruiting

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

    Nicole Moxon, RN, 503-215-1979, canrsrchstudies@providence.org

    David Page, MD

    Recruiting

Other trials in United States

About this study

Official title: A Phase II, Single-arm, Multi-center, Open-label Study of Neoadjuvant INBRX-106 (Hexavalent OX40 Agonist) in Combination With Pembrolizumab as an Induction Immunotherapy for Stage II/III TNBC Patients

This is a Phase II trial to assess efficacy and feasibility of pembrolizumab + INBRX-106 as an induction therapy preceding neoadjuvant therapy.

Read the detailed description

A Simon 2-stage design is implemented to minimize exposure if the treatment regimen is not feasible or if no response. If feasibility is established with responses exceeding futility parameters, study will expand to stage 2. Additional arms may be introduced in a protocol amendment.

Below shows the sample size required using Simon's 2-stage design, 80% power and 5% one-sided significance level:

  • Null hypothesis: <5% week 6 US response
  • Alternative hypothesis: >35% week 6 US response
  • Stage I n (r*): 6 (0)
  • Stage I + II total n (r): 12 (2)
  • Criteria: Minimax
  • Minimum responses to proceed to stage II: 1

Note: r* and r represents the threshold for declaring futility, i.e. greater than r* or r responses would be required to consider ongoing investigation.

The null hypothesis of 5% is based upon the assumption that virtually no subjects would experience volumetric reduction if the therapy was not effective. The alternative hypothesis of 35% is based upon the assumption that responses in the absence of chemotherapy in approximately one-third of subjects would be clinically meaningful, encouraging further development of the treatment paradigm.

If no responses are observed, a second feasibility run-in may be considered using a biomarker enrichment strategy (such as with the 27-gene IO score).

The arm will be terminated from further development if an unacceptable proportion of patients experience rapid clinical/radiographic progression (defined as progression of disease, or clinical evidence of progression), or other toxicities that interfere with curative-intent therapy, defined as >1/6 evaluable subjects in stage I or >2/12 in stage II, evaluated for each arm. This is a Pocock-type stopping boundary that yields the probability of cross the boundary at most 23% when the rate of dose-limiting toxicity is equal to 10%.

Being tested
Pembrolizumab, INBRX-106
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabDrug

    Also called KEYTRUDA

    Drug will be delivered per standard-of-care as established by trial Keynote-522.

  • INBRX-106Drug

    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.

Study groups in NCT06353997
Study groupRoleWhat they receive
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.
Receives: Drug: Pembrolizumab; Drug: INBRX-106

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Volumetric Response

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

    Measured: At the end of Cycle 2 (each cycle is 21 days)

Secondary outcomes (6)

  1. Pathological response (following extended INBRX-106 + pembrolizumab)

    Patients achieving pathological response after completion of study therapy followed by additional neoadjuvant therapy per treating physician discretion, ascertained at the time of definitive surgery.

    Measured: 30 days from last dose of study treatment

  2. Pathological response (post-chemotherapy)

    Number of patients achieving pathological response following extended anti-OX40 + pembrolizumab if continued beyond 2 cycles (option 2).

    Measured: 30 days from last dose of study treatment

  3. IO-path response assessed prior to Cycle 2

    On study biopsy conducted prior to Cycle 2:

    • IO-path-NE (not evaluable): no tumor or evidence of treatment effect.
    • IO-path-NR (no response): tumor present, no appreciable treatment effect, no sTILs/iTILs expansion by at least 10% absolute increase from baseline.
    • IO-path-PR (partial response): tumor present, +treatment effect and/or sTILs/iTILs expansion by at least 10% absolute increase from baseline.
    • IO-path-CR (complete response): no viable tumor, + treatment effect.

    Measured: Day 21

  4. Event free survival

    Date of dose 1 until evidence of cancer recurrence or death. Those alive without recurrence are censored at 5 years after the last dose of study drug.

    Measured: Up to 2 years

  5. Overall survival

    Date of dose 1 to death. Those who are alive are censored at 5 years after the last dose of study drug.

    Measured: Up to 2 years

  6. Toxicity profile

    All AEs attributed to study therapy per CTCAE v5.0

    Measured: 30 days from last dose of study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2024
  2. Study start5 Sep 2024
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06353997
Sponsor's protocol ID
2024000099
Status last verified
Sep 2026
First submitted
26 Mar 2024
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab and INBRX-106 in people with Triple Negative Breast Cancer, run by Providence Health & Services at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nicole Moxon, RN (503-215-1979, canrsrchstudies@providence.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Volumetric Response (time frame: At the end of Cycle 2 (each cycle is 21 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06353997.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.

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