Actively Recruiting
Isunakinra Alone and in Combination With Pembrolizumab in Patients With Colorectal Cancer (MSS)
Led by Buzzard Pharmaceuticals · Updated on 2026-03-31
20
Participants Needed
2
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will enroll patients with colorectal cancer that is locally advanced or metastatic. The tumor must be microsatellite stable (MSS), have a tumor mutational burden that is high (TMB-H) and be kras mutated. Patients must have been treated with available approved treatments already. In this study the investigators are testing a new type of immunotherapy, the potent IL-1 inhibitor isunakinra to be added to already approved immunotherapy (PD-1/PD-L1 inhibitor) in an attempt to get this treatment to work in this treatment resistant type of tumor.
CONDITIONS
Official Title
Isunakinra Alone and in Combination With Pembrolizumab in Patients With Colorectal Cancer (MSS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed adenocarcinoma of the colon or rectum
- Tumor is RAS-mutated (KRAS, NRAS or HRAS), microsatellite stable/proficient in mismatch repair, and has tumor mutational burden (TMB) of 10 MB or more
- Measurable disease by radiographic criteria (RECIST 1.1 and iRECIST)
- Completed or progressed on at least one prior line of therapy for metastatic disease, with no available effective therapy
- Minimum of 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin C), immunotherapy, or radiation
- Recovered from clinically significant toxicity of prior therapy (grade 1 or baseline)
- ECOG performance status of 0 or 1
- Normal organ function: serum creatinine 1.5 x upper limit or creatinine clearance 60 mL/min; ALT and AST 3 x upper limits; total bilirubin 1.5 x upper limit (or 3.0 if Gilbert's syndrome)
- Hematologic parameters: granulocyte count 1,500/mm3, platelet count 75,000/mm3
- Baseline pulse oximetry > 90% on room air at rest
You will not qualify if you...
- Pregnant or breastfeeding women
- Receiving concurrent cancer treatment except as allowed
- Significant disease that may impair tolerance to study treatment
- Dementia, altered mental status, or psychiatric condition preventing informed consent
- Active autoimmune diseases requiring treatment, except stable autoimmune endocrine diseases or vitiligo/alopecia
- Use of systemic steroids except physiologic doses or limited pharmacologic doses
- Use of other investigational agents within 28 days before study treatment
- Untreated or recently treated brain metastases within 2 months
- Severe hypersensitivity to pembrolizumab or similar agents
- Serious uncontrolled illnesses including infections, heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
- HIV-positive status
- Unwillingness to use adequate contraception before and during study plus 3 months after therapy completion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
USC/Norris Cancer Center
Los Angeles, California, United States, 90089
Actively Recruiting
2
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92658
Actively Recruiting
Research Team
M
Maarten de Chateau, MD PhD
CONTACT
H
Hans Olivecrona, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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