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

Exclusion criteria

• ✕. Subjects must have:
• ✕. The study patients are required to have measurable disease by radiographic criteria (RECIST 1.1 and iRECIST).
• ✕. Prior therapy: Patients must have completed or had disease progression on at least one prior line of disease-appropriate therapy for metastatic disease (with or without PD-1 inhibitors), with no available therapy likely to convey clinical benefit, or not be candidates for therapy of proven efficacy for their disease.
• ✕. There should be a minimum of 2 weeks wash out period from chemotherapy and/or radiation therapy, and 4 weeks wash out period for immunotherapy.
• ✕. Patients must have recovered (grade 1 or baseline) from any clinically significant toxicity associated with prior therapy (for example, alopecia is not clinically significant).
• ✕. ECOG performance status ≤ 1
• ✕. Patients must have normal organ and hematologic function as defined below:
• ✕. Patients must have baseline pulse oximetry \> 90% on room air at rest.