Efficacy and Safety of MW032 and Xgeva® in Subjects With Bone Metastases From Solid Tumors

Mabwell Bioscience

Status and phase: Completed; Phase 3

Conditions: Bone Metastases

Treatments: Drug: MW032; Drug: Xgeva

Study type: Interventional

Funder types: Industry

Identifiers

NCT04812509

MW032-2019-CP301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 708 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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708 participants in 2 patient groups

MW032

Experimental group

Description:

MW032 injection(120mg) was administered subcutaneously once every 4 weeks for a maximum of 13 consecutive doses throughout the trial, according to the investigator's assessment.

Treatment:

Drug: MW032

Xgeva®

Active Comparator group

Description:

Xgeva® injection(120mg) was administered subcutaneously every 4 weeks for a maximum of 13 cumulative doses throughout the trial,according to the investigator's assessment.

Treatment:

Drug: Xgeva