Isunakinra Alone and in Combination With Pembrolizumab in Patients With Colorectal Cancer (MSS)
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Buzzard Pharmaceuticals
- Study ID
- NCT06634875
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Colorectal Cancer Metastatic
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- isunakinra — DRUGIsunakinra is a potent IL1R1 inhibitor
Study Details
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.
Key Dates
- Start date
- Jan 30, 2025
- Status verified
- Mar 2025
- Primary completion
- Jun 30, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: combination immunotherapy
Primary Outcome Measure
Safety [ Time Frame: 6 months ]
Central Contacts
- Maarten de Chateau, MD PhD+46 763 103031
- Hans Olivecrona, MD PhD
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| USC/Norris Cancer Center | Los Angeles | California | 90089 | Rabia Rehman, MBBS, MHA |
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92658 | - |
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