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 — DRUG
    Isunakinra 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

Locations (2)

FacilityCityStateZIPSite coordinators
USC/Norris Cancer CenterLos AngelesCalifornia90089
Rabia Rehman, MBBS, MHA
Hoag Memorial Hospital PresbyterianNewport BeachCalifornia92658-

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