Isunakinra Alone and in Combination With Pembrolizumab in Patients With Colorectal Cancer (MSS)

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.

Trial Details

NCT ID
NCT06634875
Phase
PHASE2
Sponsor
Buzzard Pharmaceuticals
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • isunakinra
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Newport Beach, California, United States|33.61891,-117.92895

Key Eligibility Criteria

  • 1\. Subjects 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 immunohistochemi…
  • 2\. The study patients are required to have measurable disease by radiographic criteria (RECIST 1.1 and iRECIST).

For full eligibility, visit ClinicalTrials.gov.

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