Efficacy and Safety of LY01011 and Xgeva® in Patients With Bone Metastases From Solid Tumors
Efficacy and Safety of LY01011 and Xgeva® in Patients With Bone Metastases From Solid Tumors
This is a multicenter，randomized, double-blind, active-controlled, parallel-group study
 comparing efficacy and safety of LY01011 (recombinant anti-RANKL human monoclonal antibody
 injection) and Xgeva® in patients with bone metastases from solid tumors.
The primary objective is to evaluate the similarity of clinical efficacy between LY01011 and
 Xgeva® in patients with bone metastases from solid tumors.

 The secondary objective is to evaluate the similarity of clinical safety and immunogenicity
 between LY01011 and Xgeva® in patients with bone metastases from solid tumors.

 Each subject will participate in the study for 53 weeks. Treatments are administered on day 1
 and Q4W thereafter through week 49. All patients are instructed to take 500 mg calcium and
 400 IU vitamin D daily.
Inclusion Criteria:

 -  The subject or his/her guardian and/or impartial witness voluntarily signed the
 written informed consent form（ICF）.

 -  Aged 18 to 80 Years old (Female or male subjects to the date of signing the informed
 consent form).

 -  Subjects with solid tumor confirmed by histological or cytological examination. At
 least one documented bone metastasis confirmed by computed tomography[CT], magnetic
 resonance 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 or
 oral bisphosphonates, etc.) for advanced tumor disease.

 -  Orthopedic surgery or bone-related radiation therapy within 1 month prior to first
 dose. Bone radioisotope therapy within 6 months prior to first dose, or planned
 radiation therapy or surgery for bone during the study.

 -  Past or ongoing osteomyelitis or osteonecrosis of the jaws （ONJ）, an active dental or
 jaw condition requiring oral surgery, non-healed dental or oral surgery, or any
 planned invasive dental procedure during the study period.

 -  Primary central nervous system malignancy. Subjects with central nervous system
 metastases who have failed local therapy. Subjects with asymptomatic brain metastases
 or clinically stable brain metastases who do not require steroids and other therapy
 for brain metastases for ≥ 28 days may be enrolled.