SHR-3821 in Advanced Colorectal Cancer: an Exploratory Study

You may not qualify if:

• Presence of concurrent active malignancies other than the primary tumor (except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder cancer, ductal carcinoma in situ of the breast, papillary thyroid carcinoma, and gastrointestinal tumors confirmed cured by endoscopic mucosal resection). History of prior malignancy is allowed if the disease has been cured for ≥2 years.
• Patients with untreated or active central nervous system (CNS) metastases or leptomeningeal metastasis. Patients are eligible if they have received local therapy, have stable neurological symptoms for at least 2 weeks prior to the first dose, and do not require corticosteroids or require ≤10 mg/day of prednisone (or equivalent).
• Presence of severe complications at the primary site (e.g., perforation, obstruction, uncontrollable massive hemorrhage).
• Uncontrolled or moderate-to-large pleural effusion or pericardial effusion. Clinically symptomatic moderate or severe ascites (patients with small ascites detected only by imaging without clinical symptoms are eligible).
• Uncontrolled hypertension or history of hypertensive crisis.
• Significant cardiovascular or cerebrovascular diseases, including but not limited to:
• Left ventricular ejection fraction (LVEF) \<50% within 28 days prior to the first dose.
• Severe cardiac arrhythmia or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, grade ii-iii atrioventricular block.
• Acute coronary syndrome, congestive heart failure (new york heart association (NYHA) class ≥II), aortic dissection, stroke, or other grade 3 or higher cardiovascular/cerebrovascular events within 6 months prior to the first dose.
• Average QTc interval ≥450 ms for males and ≥470 ms for females based on two electrocardiogram (ECG) measurements (QTcF=QT/RR\^0.33).
• Arterial/venous thrombotic events, such as cerebrovascular accident, deep vein thrombosis, or pulmonary embolism, within 6 months prior to the first dose.
• Major surgery (defined as surgery requiring general anesthesia and a recovery period of at least 3 weeks) within 28 days prior to the first dose of study drug (diagnostic biopsy is allowed).
• Active tuberculosis or history of active tuberculosis infection within ≤48 weeks prior to screening, regardless of treatment.
• History of interstitial lung disease (ILD), or radiographic findings suggestive of or cannot rule out ild at screening; or other moderate-to-severe pulmonary diseases that significantly impair lung function.
• Active hepatitis b or active hepatitis c (HBV DNA≥1x10\^3).
• +7 more criteria