Efficacy and Safety of LY01011 and Xgeva® in Patients With Bone Metastases From Solid Tumors

Inclusion Criteria:

• The subject or his/her guardian and/or impartial witness voluntarily signed thewritten informed consent form（ICF）.
• Aged 18 to 80 Years old (Female or male subjects to the date of signing the informedconsent form).
• Subjects with solid tumor confirmed by histological or cytological examination. Atleast one documented bone metastasis confirmed by computed tomography[CT], magneticresonance imaging[MRI]) or pathology (bone biopsy).
• Eastern Cooperative Oncology Group（ECOG）performance status≤2.
• Adequate organ function at baseline.

Exclusion Criteria:

• Prior treatment with denosumab or other RANKL-targeted therapeutic drugs.
• Subjects who previously received any bone-modifying agents (including intravenous ororal bisphosphonates, etc.) for advanced tumor disease.
• Orthopedic surgery or bone-related radiation therapy within 1 month prior to firstdose. Bone radioisotope therapy within 6 months prior to first dose, or plannedradiation therapy or surgery for bone during the study.
• Past or ongoing osteomyelitis or osteonecrosis of the jaws （ONJ）, an active dental orjaw condition requiring oral surgery, non-healed dental or oral surgery, or anyplanned invasive dental procedure during the study period.
• Primary central nervous system malignancy. Subjects with central nervous systemmetastases who have failed local therapy. Subjects with asymptomatic brain metastasesor clinically stable brain metastases who do not require steroids and other therapyfor brain metastases for ≥ 28 days may be enrolled.