Clinical Research Directory

Inclusion Criteria: 1. Able and willing to provide written informed consent and to comply with the study protocol; 2. Subject with histologically or cytologically confirmed advanced and/or metastatic solid tumors who have progressed on all standard therapies, are intolerant to Standard-Of-Care (SOC), and/or are non-amenable to SOC; 3. At least one measurable lesion according to RECIST v1.1; 4. Patients with colorectal cancer must have a microsatellite instability (MSI) test report, and patients with other tumor types must have a prior PD-L1 histopathological examination report; if unavailable, tumor tissue specimens must be provided for the above tests.; 5. Life expectancy \>=12 weeks; 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 7. Adequate major organ function; 8. Women of Childbearing Potential must have a negative pregnancy test within 7 days prior to the first dose: Agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods; 9. Men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods and refrain from donating sperm. Exclusion Criteria: 1. Patients with primary CNS tumors or new or symptomatic CNS metastases. 2. Patients with a known history of another malignancy within 5 years prior to signing the informed consent. 3. Patients with significant cardiovascular and cerebrovascular diseases. 4. Presence of any of the following within 8 weeks before the first dose: symptomatic radiation pneumonitis, radiation esophagitis, or radiation-induced colitis/proctitis; interstitial lung disease; pulmonary disease with severe obstructive ventilatory impairment; unhealed peptic ulcer; cirrhosis-related complications; chronic enteritis; ischemic necrotizing enteritis; gastrointestinal obstruction; tendency to gastrointestinal bleeding or high risk of gastrointestinal perforation; pancreatitis requiring treatment; arterial or venous thrombotic disease; chronic nephritis; or nephrotic syndrome. 5. Any active autoimmune disease, or autoimmune or inflammatory disease requiring immunosuppressive therapy. 6. History of Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug-induced hypersensitivity syndrome (DIHS). 7. History of allogeneic hematopoietic stem cell transplantation or organ transplantation, or currently awaiting transplantation. 8. Immune-related adverse events during prior antitumor therapy that make the patient no longer suitable for continued immunotherapy. 9. Prior treatment with PD-1/IL-2 or PD-1/IL-15 agents.