Triple-Negative Breast Cancer study: Group
Official title Enhancing ICB Efficacy Through IL-1 Inhibition in TNBC
ClinicalTrials.gov ID: NCT07698106
What this study is testing
What is Group 1-Isunakinra?
Group 1-Isunakinra is an investigational medicine, given as a once-daily injection under the skin, being studied as a potential treatment for triple-negative breast cancer (tnbc).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a phase I/II open-label randomized clinical trial to examine whether administration of isunakinra (EBI-005), a modified recombinant IL1 receptor antagonist, can sensitize human TNBC to the PD1 inhibitor-pembrolizumab-based neoadjuvant chemotherapy (NAC/P) by changing the tumor microenvironment (TME) via reducing the recruitment of immunosuppressive tumorassociated macrophages (TAMs) and increasing activated cytotoxic T-lymphocytes (CTLs).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age \> 18 years
- Newly diagnosed, locally advanced, previously untreated and centrally confirmed TNBC, as defined by the most recent American Society of Clinical...
- Provides core needle biopsies consisting of at least 2 separate tumor cores from the primary tumor to the central laboratory
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Demonstrates adequate organ function
You likely can't join if
- Male Gender
- Luminal A/B and HER2 positive breast cancer
- Multifocal early breast cancer
- History of invasive malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or...
- Received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months
- Has received prior therapy with an anti-PD1, anti-PDL1/-PDL2 agent or with an agent directed to another co-inhibitory T-cell receptor
See the full eligibility criteria
- Age \> 18 years
- 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...
- Provides core needle biopsies consisting of at least 2 separate tumor cores from the primary tumor to the central laboratory
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Demonstrates adequate organ function
- Participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study
- Male Gender
- Luminal A/B and HER2 positive breast cancer
- Multifocal early breast cancer
- 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
- Received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months
- Has received prior therapy with an anti-PD1, anti-PDL1/-PDL2 agent or with an agent directed to another co-inhibitory T-cell receptor
- Participated in an treatment clinical study with an investigational compound or device within 4 weeks of randomization for this study
- Pre-existing inflammatory arthritis
- Has received a live vaccine within 30 days of the first dose of study treatment
- 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)
- 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...
- Active or uncontrolled Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C
- Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
- Has an active infection requiring systemic therapy
- Has significant cardiovascular disease
- Is pregnant or breastfeeding, or expecting to conceive children within the duration of the study
- Has a known history of active tuberculosis (TB, Bacillus Tuberculosis)
- Platelets ≤ 100x109/L. ANC ≤ 1.5 x109/L. Hemoglobin ≤ 80 g/L
- ECOG≥2
- History of stroke or intracranial hemorrhage within 6 months prior to enrollment
- Presence of moderate or severe renal function impairment (estimated creatinine clearance \<60 mL/min/1.73m2)
- Patients with mild, moderate, or severe hepatic impairment or inadequate liver function (total bilirubin \> 23 umol/L, serum albumin \ 1.70)
- Known hypersensitivity to E-coli derived proteins, isunakinra or any component of the product
The study team makes the final eligibility decision.
Where it is enrolling
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.