Clinical trial NCT04812509: Efficacy and Safety of MW032 and Xgeva® in Subjects With Bone Metastases From Solid Tumors
Official title: A Multi-center, Randomized, Double-blind, Parallel Controlled Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of Recombinant Human Anti RANKL Monoclonal Antibody Injection (MW032) and Denosumab (Xgeva®) in Subjects With Bone Metastases From Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bone Metastases
Keywords: Denosumab
Biosimilarity
pharmacokinetics
pharmacodynamics
safety
Lead sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-03-23
Enrollment: 708
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: uNTx/uCr
timeFrame: from baseline to week 13
Secondary outcomes:
measure: uNTx/uCr
timeFrame: from baseline to weeks 5,25,37 and 53
measure: S-BALP
timeFrame: from baseline to weeks 5,13,25,37 and 53
measure: SRE
timeFrame: from baseline to week 53
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fifth Medical Center of PLA General Hospital
state: Beijing
Study officials:
References: