Neoplasms

Musculoskeletal Diseases

All Conditions

Bone Neoplasms

Bone Diseases

Bone Density Conservation Agents

All Drugs and Chemicals

Denosumab

MW032 injection (120mg) by subcutaneous injection once on the first day of treatment.

Xgeva® injection (120mg) by subcutaneous injection once on the first day of treatment.

Subjects would receive a single 120mg (1.7 mL) of MW032 through subcutaneous injection, on the first day of treatment.

MW032

Subjects would receive a single 120mg (1.7 mL) of Xgeva® through subcutaneous injection, on the first day of treatment.

Xgeva®

A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of MW032 and Xgeva® in healthy adults.

This is a phase I, single center, randomized, double-blind and parallel group clinical trial.

The primary objective is to assess the pharmacokinetic similarity of single and subcutaneous injections of MW032 and Xgeva® in healthy volunteers.

The secondary objective are to assess the Clinical safety and immunogenicity similarity of single and subcutaneous injections of MW032 and Xgeva® in healthy volunteers.

At the same time, preliminary evaluate the pharmacodynamic similarity between MW032 and Xgeva®.

Subjects would receive a single 120mg（1.7mL）of MW032 or Xgeva® through subcutaneous injection.

Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of MW032 and Xgeva® in Healthy Adults

A Single Center, Randomized, Double-blind , Single-dose, and Parallel Group Study to Compare the Pharmacokinetic, Safety and Pharmacodynamic of MW032 and Xgeva® in Healthy Adults

The adverse medical events that occur after the clinical trial subjects receive the test drug do not necessarily have a causal relationship with the treatment.

CTX1 is a serum type I collagen C-terminal peptide to detect the bone metastasis events.

Mabwell (Shanghai) Bioscience Co., Ltd.

Symptoms and General Pathology

Blood and Lymph Conditions

Neoplasm Metastasis

Bone Marrow Diseases

Neoplastic Processes

Hematologic Diseases

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Subcutaneous injection of LY01011 120 mg (1.7ml) every 4 weeks for a maximum of 13 consecutive doses up to week 49.

After subcutaneous injection of Xgeva® 120 mg (1.7ml) every 4 weeks 3 times, patients of Xgeva® group continue to receive LY01011 120 mg (1.7ml) every 4 weeks for ten doses consecutively.

subcutaneously (SC) once every 4 weeks (Q4W)

LY01011

Xicheng Wang, master

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.

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

A Phase III Study Comparing Efficacy and Safety of LY01011 and Xgeva®(Denosumab) in Patients With Bone Metastases From Solid Tumors

Compare LY01011 and Xgeva® for natural logarithm change in bone turnover marker(BTM) -urinary type I collagen cross-linked N-telopeptides (uNTx) corrected for urine creatinine(uCr) in chinese subjects with bone metastases from solid tumors.

Luye Pharma Group Ltd.

Skin and Connective Tissue Diseases

Rare Diseases

Giant Cell Tumors

Giant Cell Tumor of Bone

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Bone Tissue

Participants with surgically unsalvageable disease (eg, sacral, spinal Giant cell tumor of bone \[GCTB\], or multiple lesions including pulmonary metastases).

Participants with surgically salvageable disease whose planned on-study surgery is associated with severe morbidity (eg, joint resection, limb amputation, or hemipelvectomy).

Participants will receive XGEVA® 120 mg subcutaneously (SC) once every 4 weeks (Q4W) with a loading dose of 120 mg SC on day 8 and day 15.

XGEVA®

Amgen Call Center

The study aims to evaluate the efficacy of XGEVA® in Chinese participants with giant cell tumor of bone (GCTB).

Study of XGEVA® (Denosumab) in Chinese Adults and Skeletally Mature Adolescents With Giant Cell Tumor of the Bone

An Open-label, Multi-center, Phase 4 Study of XGEVA® (Denosumab) in Chinese Adults and Skeletally Mature Adolescents With Giant Cell Tumor of the Bone

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Objective tumor response is defined as the percentage of participants with complete response (CR) or partial response (PR) evaluated based on European Organisation for Research and Treatment of Cancer (EORTC) criteria and Response Evaluation Criteria in Solid Tumors (RECIST).

Pain severity will be assessed using Brief Pain Inventory - Short Form. The minimum score is 0 (no pain) and the maximum score is 10 (worst pain imaginable). The higher the score means a worse outcome of more pain.

Adverse events of special interest include hypocalcemia, hypercalcemia following investigational product discontinuation, atypical femoral fracture, and osteonecrosis of the jaw.

Amgen

Subcutaneously injection of HS-20090 (120mg/1.7mL) once on the first day

Subcutaneously injection of Xgeva® (120mg/1.7mL) once on the first day

A human IgG2 monoclonal antibody with affinity and specificity for human RANKL

HS-20090

A randomized, double-blind and parallel group study to compare the pharmacokinetic, pharmacodynamic, safety and immunogenicity of HS-20090 120mg（1.7ml）and Xgeva® in healthy adults.

This is a phase I, single center, randomized, double-blind and parallel group clinical trial .

The primary objective is to assess the pharmacokinetic similarity of single subcutaneously injection of HS-20090 or Xgeva® in healthy volunteers.

The secondary objectives are to assess the Clinical safety and immunogenicity similarity of single subcutaneously injection of HS-20090 or Xgeva® in healthy volunteers. Meanwhile，observing the pharmacodynamic similarity of HS-20090 to Xgeva® preliminarily.

Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults

A Randomized, Double-blinded and Parallel Study to Assess the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults

percentage of subjects positive for antidrug antibody

explore the pharmacodynamic profile by detecting the serum concentration of CTX1

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of MW032 and Xgeva® in Healthy Adults	NCT04798326	Bone Tumor	MW032 Xgeva®	18 Years - 65 Years	Mabwell (Shanghai) Bioscience Co., Ltd.
Efficacy and Safety of LY01011 and Xgeva® in Patients With Bone Metastases From Solid Tumors	NCT04859569	Bone Metastases...	LY01011 Xgeva®	18 Years - 80 Years	Luye Pharma Group Ltd.
Study of XGEVA® (Denosumab) in Chinese Adults and Skeletally Mature Adolescents With Giant Cell Tumor of the Bone	NCT04586660	Giant Cell Tumo...	XGEVA®	12 Years -	Amgen
Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults	NCT04494373	Bone Metastasis...	HS-20090 Xgeva®	18 Years - 50 Years	Jiangsu Hansoh Pharmaceutical Co., Ltd.

Spots Global Cancer Trial Database for xgeva®

Every month we try and update this database with for xgeva® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for xgeva®

Every month we try and update this database with for xgeva® cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for xgeva® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.