Clinical Research Directory

Inclusion Criteria: * Male or female patients aged over 18 years (inclusive); * ECOG score: 0 - 2 points * Patients with histologically or cytologically confirmed locally advanced or metastatic solid tumors, including TNBC and HNSCC * No previous treatment with CPI * Agreement to provide a previously archived tumor tissue specimen or biopsy to collect tumor lesion tissue * Subject has at least 1 measurable lesion as defined by RECIST V1.1 * Expected survival ≥ 6 months * Adequate organ function * Males of childbearing potential or females of childbearing potential must use highly effective contraceptive methods during the trial and continuing for 6 months after the last dose * The subject voluntarily joined the study and signed an informed consent form Exclusion Criteria: * Pregnant or lactating women; * Prior cell therapy; * Received systemic anti-tumor therapy within 2 weeks or 5 half-lives of the treatment agent (whichever is shorter) before the start of treatment; * Previous or current presence of two or more primary tumors * Patients with active autoimmune diseases * Have received systemic treatment with corticosteroids (10 mg prednisone equivalent daily) or other immunosuppressive agents for more than 7 days within 2 weeks before the start of treatment * Received investigational drugs within 2 weeks before the start of treatment; * Major surgery or serious trauma within 4 weeks before the start of treatment; * Patients with symptomatic central nervous system (CNS) metastasis * Active viral infectious disease requiring systemic treatment at screening: * Known serious hypersensitivity history * Uncontrolled pleural effusion, ascites, or pericardial effusion at screening; * Presence or history of active interstitial lung disease; * Patients with hypertension that cannot be well controlled with medical therapy. * Presence of clinically significant cardiovascular disease * Deep venous thrombosis within 6 months before the start of treatment * Thrombolytic therapy within 10 days prior to the start of treatment * Any active infection requiring intravenous anti-infective therapy before the start of treatment * Had toxicity not resolved to ≤ Grade 1 (CTCAE 5.0) from previous anticancer therapy * Known or suspected inability to comply with the study protocol