Xgeva®

DRUG7 trials

Sponsors

Qilu Pharmaceutical Co., Ltd., Jiangsu Hansoh Pharmaceutical Co., Ltd., Amgen, Mabwell (Shanghai) Bioscience Co., Ltd., Luye Pharma Group Ltd.

Conditions

Bone Metastases From Solid TumorsBone Metastasis From Solid TumorsBone TumorGiant Cell Tumor of BoneHealthyHealthy PeopleHealthy Volunteers

Phase 1

Comparing of the Pharmacokinetic, Safety and Pharmacodynamic of QL1206 and Xgeva® in Healthy Adults

CompletedNCT03651947

Qilu Pharmaceutical Co., Ltd.Healthy People

Start: 2018-08-20End: 2019-05-22Updated: 2019-10-16

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

Jiangsu Hansoh Pharmaceutical Co., Ltd.Bone Metastasis From Solid Tumors

Start: 2020-09-01End: 2021-06-30Target: 154Updated: 2020-08-04

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

CompletedNCT04798326

Mabwell (Shanghai) Bioscience Co., Ltd.Bone Tumor

Start: 2019-06-25End: 2020-02-26Updated: 2021-03-15

Comparing of the PK, PD, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults

Jiangsu Hansoh Pharmaceutical Co., Ltd.Healthy

Start: 2023-04-20End: 2024-04-05Target: 180Updated: 2023-08-23

Study of CMAB807X Pre- and Post-change in Manufacturing Site and Xgeva® in Healthy Volunteers

WithdrawnNCT05808673

Taizhou Mabtech Pharmaceutical Co.,LtdHealthy Volunteers

Start: 2023-02-28End: 2024-07-31Updated: 2024-04-09

Phase 3

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

Luye Pharma Group Ltd.Bone Metastases From Solid Tumors

Start: 2021-04-30End: 2023-06-30Target: 850Updated: 2021-06-07

Phase 4

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

Active, not recruitingNCT04586660

AmgenGiant Cell Tumor of Bone

Start: 2023-08-17End: 2028-03-07Updated: 2025-10-01

Related Papers

Denosumab biosimilar (LY01011) in the treatment of bone metastases in patients with solid tumors: A multicenter, randomized, double-blind, active comparator-controlled phase 3 study.

Journal of Clinical Oncology2023-06-01

Efficacy and Safety of Denosumab Biosimilar QL1206 Versus Denosumab in Patients with Bone Metastases from Solid Tumors: A Randomized Phase III Trial

BioDrugs2023-02-2111 citations

Biosimilarity of HS-20090 to Denosumab in healthy Chinese subjects: a randomized, double-blinded, pharmacokinetics/pharmacodynamics study

Expert Opinion on Investigational Drugs2022-09-165 citations