Efficacy and Safety of MW032 and Xgeva® in Subjects With Bone Metastases From Solid Tumors
Efficacy and Safety of MW032 and Xgeva® in Subjects With Bone Metastases From Solid Tumors
A multi-center, randomized, double-blind, parallel controlled Phase III clinical study to
 evaluate the clinical efficacy and safety of MW032 and Xgeva® in patients with bone
 metastases from solid tumors.
This is A multi-center, randomized, double-blind, parallel controlled Phase III clinical
 trial.

 The primary objective is to evaluate the clinical efficacy of MW032 and Xgeva® in patients
 with bone metastases from solid tumors.

 The secondary objective are to evaluate the clinical safety and immunogenicity of MW032 and
 Xgeva® in patients with bone metastases from solid tumors.
Inclusion Criteria:

 1. Pathological confirmed malignant tumors (except hematological tumors);

 2. Bone metastasis diagnosed by imaging (bone X-ray, CT scanning or magnetic resonance
 scanning) or pathology (bone biopsy) can be examined within 3 months before signing
 the informed consent,according to 《The expert consensus on clinical diagnosis and
 treatment of bone metastases and bone related diseases of malignant tumors (2014)》；

 3. No limited of gender,age ≥ 18 years old;

 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2;

 5. Estimated survival time was more than 6 months;

 6. Subjects must have adequate organ function at baseline as defined below:① hematology:
 neutrophils ≥ 1,500/mcL, platelets ≥ 75,000/mcL, hemoglobin ≥ 80 g / L; ② renal
 function: creatinine (CR) clearance rate ≥ 30 ml / min; ③ Liver function: serum
 aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were less than or
 equal to 2.0 × upper normal limit (ULN) in subjects without liver metastasis; ALT and
 AST were less than or equal to 5.0 × ULN in subjects with liver metastasis; serum
 total bilirubin was less than or equal to 1.5 × ULN; ④ serum calcium (albumin
 correction) was more than or equal to 2.0 mmol / L (8.0 mg / dl) but less than or
 equal to 2.9 mmol / L (11.5 mg / dl). Note: calcium supplements should not be used at
 least 8 hours before serum calcium determination in screening period;

 7. Subjects has understood the nature and purpose of the study, as well as the research
 procedure, and the subject has signed the written informed consent;

 Exclusion Criteria:

 1. Subjects with diseases not suitable for the study,in the Investigator's opinion
 (according to the subject's report or medical record review), such as:Other malignant
 tumors (different from the malignant solid tumors required in this study protocol)
 occurred within 3 years before enrollment, and in the active period;Other diseases
 affecting bone metabolism, such as vitamin D deficiency rickets, osteomalacia and
 primary osteoporosis, hyperparathyroidism, osteitis deformans, etc. (excluding
 osteoporosis);Human immunodeficiency virus or Treponema pallidum infection;Unstable
 liver disease, active period of hepatitis B virus or hepatitis C virus infection;Other
 serious or unstable physical or mental disorders.

 2. Brain metastasis.

 3. Oral and dental diseases: previous or current evidence of osteomyelitis or necrosis of
 the jaw; acute dental or mandibular diseases, need to be treated oral surgery; planned
 invasive dental surgery; failed dental or oral surgery.

 4. Subjects with bone metastases need radiotherapy or surgery.

 5. Previous treatment with denosumab.

 6. Patients who had received any kind of intravenous or oral bisphosphonates before
 administration of the first study drug.