A Phase I/II Clinical Study to Evaluate the Safety and Efficacy of RCZY690 in Advanced Solid Tumors

Inclusion criteria

• Voluntarily participate in this study, sign the informed consent form, and be able to comply with the study protocol.
• Age between 18 and 75 years inclusive.
• ECOG performance status of 0 or 1.
• Expected survival ≥ 12 weeks.
• At least one measurable target lesion based on imaging assessment per RECIST version 1.1 criteria.
• Adequate bone marrow, hepatic, renal and coagulation function.

Exclusion criteria

• Female participants who are pregnant, lactating, or planning to become pregnant.
• Participants with brain metastases.
• History of severe bleeding tendency or coagulation dysfunction.
• Toxicities from prior anti-tumor therapy have not recovered to Grade 1 per NCI-CTCAE version 6.0.
• Known hypersensitivity or delayed-type allergic reaction to any components of the investigational drug or similar agents.
• Any condition that impairs the participant's ability to swallow study medication, or conditions judged by the investigator to significantly affect study drug absorption.
• Participants with acute, chronic or symptomatic infection.
• Uncontrolled cardiovascular disease.
• Participants with confirmed or suspected interstitial lung disease (ILD), drug-related pneumonitis or other pulmonary diseases.
• History of liver cirrhosis (Child-Pugh Class B or C).
• Active inflammatory bowel disease.
• Participants with uncontrolled diabetes (HbA1c ≥10%).
• Arterial or venous thromboembolic events within 6 months prior to the first study drug administration.
• Pericardial effusion, cardiac tamponade, or third-space effusions (including massive pleural effusion or ascites) that cannot be stably controlled by drainage or other measures as judged by the investigator.
• Active autoimmune disease requiring systemic therapy within the past 2 years.
• History of other invasive malignancies within 5 years prior to first dose, or any evidence of residual disease from previously diagnosed malignancy.
• History of acquired or congenital immunodeficiency disorders, or history of organ transplantation.
• Past or current poorly controlled psychiatric disorders.
• Poor compliance, and participants who are expected to be unable to comply with study procedures.