Could a modified protein help immunotherapy fight a tough breast cancer?

NCT ID NCT07698106

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This study investigates whether adding isunakinra, a modified protein that blocks inflammation, can make triple-negative breast cancer more sensitive to standard immunotherapy and chemotherapy. The trial enrolls adults with newly diagnosed, locally advanced triple-negative breast cancer. Researchers will measure changes in the tumor environment to see if isunakinra helps the immune system attack the cancer more effectively.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
isunakinra
What this could lead to
If it works, this could point toward a way to improve the effectiveness of immunotherapy for triple-negative breast cancer, potentially leading to better outcomes.
What could go wrong
This is an early-phase trial with a small number of participants, so results may not apply broadly. The drug may not improve response or could cause additional side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2034

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age \> 18 years 2. Newly diagnosed, locally advanced, previously untreated and centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines, and staging per current AJCC staging criteria for breast cancer as assessed by the investigator based on radiological and/or clinical assessment: Clinical stage T1c/N1-N2, T2-4/N0-2 3. Provides core needle biopsies consisting of at least 2 separate tumor cores from the primary tumor to the central laboratory 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 5. Demonstrates adequate organ function 6. Participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study Exclusion Criteria: 1. Male Gender 2. Luminal A/B and HER2 positive breast cancer 3. Multifocal early breast cancer 4. History of invasive malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer 5. Received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months 6. Has received prior therapy with an anti-PD1, anti-PDL1/-PDL2 agent or with an agent directed to another co-inhibitory T-cell receptor 7. Participated in an interventional clinical study with an investigational compound or device within 4 weeks of randomization for this study 8. Pre-existing inflammatory arthritis 9. Has received a live vaccine within 30 days of the first dose of study treatment 10. Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs) 11. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (i.e., dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment 12. Active or uncontrolled Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C 13. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis 14. Has an active infection requiring systemic therapy 15. Has significant cardiovascular disease 16. Is pregnant or breastfeeding, or expecting to conceive children within the duration of the study 17. Has a known history of active tuberculosis (TB, Bacillus Tuberculosis) 18. Platelets ≤ 100x109/L. ANC ≤ 1.5 x109/L. Hemoglobin ≤ 80 g/L 19. ECOG≥2 20. History of stroke or intracranial hemorrhage within 6 months prior to enrollment 21. Presence of moderate or severe renal function impairment (estimated creatinine clearance \<60 mL/min/1.73m2) 22. Patients with mild, moderate, or severe hepatic impairment or inadequate liver function (total bilirubin \> 23 umol/L, serum albumin \< 35 g/L, INR \> 1.70) 23. Known hypersensitivity to E-coli derived proteins, isunakinra or any component of the product

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

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