💬In plain words
What the trial is, and whether it could suit you
For patients with metastatic colorectal cancer (mCRC) who have failed two or more lines of standard therapy, treatment options are extremely limited, and the prognosis remains poor, with objective response rates (ORRs) generally below 5%. This is particularly challenging for patients with microsatellite-stable (MSS)/proficient mismatch repair (pMMR) tumors, who constitute the vast majority of patients with mCRC. The immunologically "cold" tumor microenvironment (TME) in these patients contributes to widespread primary resistance to PD-1 inhibitor monotherapy. A key mechanism underlying this resistance is the sustained activation of JAK/STAT signaling, which promotes immunosuppression mediated by myeloid-derived suppressor cells (MDSCs) and other immunosuppressive components, thereby limiting T-cell activity and the efficacy of strategies that solely reinvigorate T cells.
To address this
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Histologically or cytologically confirmed advanced, metastatic, or recurrent colorectal cancer, supported by radiological findings.
* Age 18-75 years.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
* Disease progression or failure of at least second-line standard therapy.
* Voluntary provision of written informed consent.
Exclusion Criteria:
* Prior treatment with a JAK1 inhibitor.
* Active autoimmune disease or primary immunodeficiency within the previous 2 years.
* Known allergy to monoclonal antibodies, sodium carboxymethylcellulose, or any of their components.
* Major cardiovascular or cerebrovascular diseases, including stroke or myocardial infarction within 6 months before enrollment, uncontrolled hypertension, unstable angina, heart failure (New York Heart Association \[NYHA\] class II-IV), or severe arrhythmias requiring pharmacological treatment.
* History of other malignancies within 5 years before enrollment, except for excised basal cell carcinoma of the skin or cervical carcinoma in situ.
* Membership in vulnerable populations, including individuals with mental or cognitive impairment, critically ill patients, minors, pregnant or breastfeeding women.
* Severe chronic obstructive pulmonary disease (COPD), interstitial lung disease, or other conditions that severely impair pulmonary function.
* Severe hepatic impairment, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 × the upper limit of normal (ULN) in patients without liver metastases, or ≥ 5 × ULN in patients with liver metastases.
* Severe renal impairment, defined as creatinine clearance (CrCl) \< 30 mL/min.
* Toxicities from previous anticancer treatment that have not recovered to Grade 1 or lower, except for alopecia.
* History of venous thrombosis.
* Active tuberculosis or active bacterial, fungal, or viral infection.
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