Colorectal Cancer Metastatic study: Isunakinra
Official title Isunakinra Alone and in Combination With Pembrolizumab in Patients With Colorectal Cancer (MSS)
ClinicalTrials.gov ID: NCT06634875
What this study is testing
What is isunakinra?
isunakinra is an investigational medicine being studied as a potential treatment for metastatic colorectal cancer. isunakinra is designed to block a specific protein called IL-1R1 to help the immune system fight the tumor.
Also referred to as EBI-005.
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
- The study aims to see if adding the IL‑1 blocker isunakinra to the approved immunotherapy pembrolizumab is safe and shows any activity in this hard‑to‑treat cancer.
- Who it's for
- Adults with locally advanced or metastatic colorectal cancer that is microsatellite stable, has a high tumor mutational burden, carries a KRAS mutation, and who have already received standard approved treatments.
- What's involved
- Participants will receive isunakinra, either by itself or together with pembrolizumab, and will have regular clinic visits and tests to check safety and tumor response.
- Time commitment
- The trial runs for several months and requires multiple treatment visits and follow‑up appointments.
- Phase 2: a mid-size study of how well it works
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
- Histologically or cytologically confirmed adenocarcinoma of the colon or the rectum
- Serum creatinine ≤ 1.5 x upper limit of normal OR creatinine clearance and a 24-h urine collection of ≥ 60 mL/min.
- ALT and AST ≤ 3x the upper limits of normal.
- Total bilirubin ≤ 1.5 x upper limit of normal OR in patients with Gilbert's syndrome, a total bilirubin ≤ 3.0.
- Granulocyte count ≥ 1,500/mm3
You likely can't join if
- people must have: ⦁ Histologically or cytologically confirmed adenocarcinoma of the colon or the rectum
- Tumor is determined to be RAS-mutated (KRAS, NRAS or HRAS) and microsatellite stable/proficient in mismatch repair, as assessed by...
- The study patients are required to have measurable disease by radiographic criteria (RECIST 1.1 and iRECIST).
- Prior therapy: Patients must have completed or had disease progression on at least one prior line of disease-appropriate therapy for metastatic...
- There should be a minimum of 2 weeks wash out period from chemotherapy and/or radiation therapy, and 4 weeks wash out period for immunotherapy.
- Patients must have recovered (grade 1 or baseline) from any clinically significant toxicity associated with prior therapy (for example, alopecia is...
See the full eligibility criteria
- Histologically or cytologically confirmed adenocarcinoma of the colon or the rectum
- Serum creatinine ≤ 1.5 x upper limit of normal OR creatinine clearance and a 24-h urine collection of ≥ 60 mL/min.
- ALT and AST ≤ 3x the upper limits of normal.
- Total bilirubin ≤ 1.5 x upper limit of normal OR in patients with Gilbert's syndrome, a total bilirubin ≤ 3.0.
- Granulocyte count ≥ 1,500/mm3
- Platelet count ≥ 75.000/mm3 8. Patients must have baseline pulse oximetry \> 90% on room air at rest.
- people must have: ⦁ Histologically or cytologically confirmed adenocarcinoma of the colon or the rectum
- Tumor is determined to be RAS-mutated (KRAS, NRAS or HRAS) and microsatellite stable/proficient in mismatch repair, as assessed by immunohistochemistry (IHC) and/or polymerase chain reaction (PCR)/next generation...
- The study patients are required to have measurable disease by radiographic criteria (RECIST 1.1 and iRECIST).
- Prior therapy: Patients must have completed or had disease progression on at least one prior line of disease-appropriate therapy for metastatic disease (with or without PD-1 inhibitors), with no available therapy likely...
- There should be a minimum of 2 weeks wash out period from chemotherapy and/or radiation therapy, and 4 weeks wash out period for immunotherapy.
- Patients must have recovered (grade 1 or baseline) from any clinically significant toxicity associated with prior therapy (for example, alopecia is not clinically significant).
- ECOG performance status ≤ 1
- Serum creatinine ≤ 1.5 x upper limit of normal OR creatinine clearance and a 24-h urine collection of ≥ 60 mL/min.
- ALT and AST ≤ 3x the upper limits of normal.
- Total bilirubin ≤ 1.5 x upper limit of normal OR in patients with Gilbert's syndrome, a total bilirubin ≤ 3.0.
- Granulocyte count ≥ 1,500/mm3
- Platelet count ≥ 75.000/mm3
- Patients must have baseline pulse oximetry \> 90% on room air at rest. Exclusion criteria
- Pregnant women or women presently breast-feeding their children are excluded due to unknown risks to a developing fetus or infant, confirmed by negative pre-treatment serum pregnancy test.
- Concurrent treatment for cancer, with specific exceptions noted in inclusion criteria.
- Any significant disease that, in the opinion of the investigator, may impair the patient's tolerance of study treatment.
- Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
- Active autoimmune diseases requiring treatment. However, patients with vitiligo, alopecia, or clinically stable autoimmune endocrine disease who are on stable dosing of appropriate replacement therapy (if such therapy...
- Concurrent use of systemic steroids, except for physiologic doses of systemic steroid replacement or local (topical, nasal, or inhaled) steroid use.
- Patients who are receiving any other investigational agents within 28 days before start of study treatment.
- Patients with untreated central nervous system metastases or local treatment of brain metastases within the last 2 months. Patients with stable brain metastasis for 2 months post-intervention are eligible.
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab or any of its excipients or a history of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in study.
- Serious or uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social...
- HIV-positive patients are ineligible because of the potential for decreased immune response.
- Patients unwilling to use adequate contraception (defined as hormonal or barrier method or abstinence) prior to study entry are excluded.
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Newport Beach, California, United States
- Atlanta, Georgia, United States
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 Los Angeles, California, United States; Newport Beach, California, United States; Atlanta, Georgia, United States. 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.