A Study of YL201 and Ivonescimab (AK112) in Advanced Solid Tumors

Inclusion criteria

• Age ≥ 18 years old.
• Inclusion criteria for the study population： Phase 1: Advanced Solid tumors. Phase 2: Extensive-stage SCLC, Non-AGA NSCLC, EGFR mutation NSCLC.
• ECOG PS score is 0 or 1.
• Within 7 days before the first dose, the functions of body organs and bone marrow meet the requirements.

Exclusion criteria

• Suitable for local curative treatment.
• Have received previous treatment with drugs targeting B7-H3 (including antibodies, ADCs, CAR-T, and other drugs).
• Have received previous treatment with topoisomerase I inhibitors or ADCs containing topoisomerase I inhibitors.
• Have experienced grade ≥ 3 irAEs during previous treatment with anti-programmed death receptor (ligand) [anti-PD-(L)1] or other immune checkpoint inhibitors.
• History of bleeding tendency or coagulation disorders and/or clinically significant bleeding symptoms or risks within 4 weeks before randomization.
• Imaging studies during the screening period show that the patient has the Imaging-confirmed tumor invasion of major blood vessels.
• Active autoimmune disease requiring systemic treatment.
• Brain metastases or spinal cord compression.
• Patients with uncontrolled or clinically significant cardiovascular diseases.
• Clinically significant concurrent pulmonary diseases.
• Known to have active pulmonary tuberculosis. Other protocol-defined inclusion/ exclusion criteria may apply