Could a modified protein help immunotherapy fight a tough breast cancer?
NCT ID NCT07698106
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 Hide 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Triple negative breast cancer (TNBC) are added.
By submitting, you agree to our Terms of use
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
Only the study team decides who joins. These are the ways to reach them.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a cocktail of immune boosters shrink Hard-to-Treat tumors?
- Can a Pre-Surgery drug combo wipe out early breast cancer?
- Can a Four-Drug combo erase Triple-Negative breast cancer before surgery?
- Can a Custom-Made vaccine outsmart Triple-Negative breast cancer?
- Can a drug combo outsmart a tough breast cancer subtype?
- Can a new drug combo outsmart triple-negative breast cancer?