NCT06634875

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

A Phase IIa, Non-Randomized, Open-Label Dose Expansion Trial of Isunakinra in Combination With Pembrolizumab in Patients With Metastatic or Unresectable, Locally Advanced Colorectal Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Buzzard Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• Colorectal Cancer Metastatic

Interventions

Type	Name	Description
DRUG	isunakinra	Isunakinra is a potent IL1R1 inhibitor

Timeline

• Start date: 2025-01-30
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2024-10-10
• Last updated: 2026-03-31

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study