A I/II Phase Clinical Study to Evaluate the Safety and Efficacy of RC288 in the Treatment of Solid Tumors

Inclusion criteria

• Voluntarily participate in this study, sign the informed consent form, and be able to adhere to the study protocol;
• Age between 18 and 75 years (including 18 and 75 years);
• ECOG PS score of 0 or 1;
• Expected survival ≥12 weeks;
• According to RECIST v1.1 criteria, based on imaging examinations, there is at least one measurable target lesion;
• Sufficient bone marrow, liver, kidney, and blood clotting function

Exclusion criteria

• Pregnant, breastfeeding, or intending to become pregnant subjects.
• Subjects with brain metastases.
• Subjects with unresolved toxicities from prior anti-tumor therapy not recovered to NCI-CTCAE v6.0 Grade 1.
• Subjects with known hypersensitivity or delayed allergic reactions to any component of the investigational drug or similar drugs.
• Subjects with acute, chronic, or symptomatic infections.
• Subjects with uncontrolled cardiovascular diseases.
• Subjects with confirmed or suspected interstitial lung disease (ILD), drug-related pneumonia, radiation pneumonitis, severely impaired pulmonary function, or other pulmonary diseases.
• History of underlying pulmonary disease.
• Subjects with a history of cirrhosis (Child-Pugh B or C class).
• Clinically significant gastrointestinal disease.
• Subjects with uncontrolled diabetes (HbA1c ≥ 10%).
• Occurrence of hemorrhagic events of Grade ≥2 per NCI CTCAE (v6.0) within 4 weeks prior to screening; or clinical manifestations suggestive of a significant bleeding tendency within 4 weeks prior to screening.
• Imaging during the screening period shows tumor invasion or involvement of vital organs, with imaging evidence judged by the investigator to indicate a risk of bleeding or fistula formation.
• History of arterial/venous thromboembolic events within 6 months prior to the first dose.
• Presence of pericardial effusion or cardiac tamponade, or third-space fluid accumulation that, in the investigator's judgment, cannot be stably controlled by drainage or other methods.
• History of active autoimmune disease requiring systemic therapy within the past 2 years.
• History of other invasive malignancies within 5 years prior to the first dose, or evidence of residual disease from any previously diagnosed malignancy.
• History of other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
• History of or current poorly controlled psychiatric disorder.
• Poor compliance, and patients who are expected to be unable to cooperate with the completion of trial procedures.
• Presence of any other disease, metabolic abnormality, physical examination finding, or laboratory abnormality that, in the investigator's judgment, gives reasonable suspicion of a condition that contraindicates the use of the investigational drug, may affect the interpretation of study results, or places the patient at high risk.
• Local or systemic diseases not caused by malignancy, or diseases or symptoms secondary to the tumor, which may lead to higher medical risks and/or uncertainty in survival assessment.