Neoplasms

Symptoms and General Pathology

All Conditions

Musculoskeletal Diseases

Blood and Lymph Conditions

Neoplasm Metastasis

Bone Neoplasms

Bone Marrow Diseases

Neoplastic Processes

Bone Diseases

Hematologic Diseases

Micronutrients

All Drugs and Chemicals

Bone Density Conservation Agents

Vitamins

Vitamin D

Cholecalciferol

Calcium

Calcium, Dietary

Trace Elements

Hormones

Vitamin D3

Calciferol

Eligible patients will receive JMT103 120 mg SC Q4W for up to 13 cycles.

Eligible patients will receive JMT103 120 mg SC Q8W for up to 7 cycles.

Eligible patients will receive JMT103 180 mg SC Q8W for up to 7 cycles.

JMT103 is administered subcutaneously at a dose of 120 mg on day 1 of each 4-week cycle.

Drug: JMT103- 120 mg SC Q4W

JMT103 is administered subcutaneously at a dose of 120 mg on day 1 of each 8-week cycle.

Drug: JMT103- 120 mg SC Q8W

JMT103 is administered subcutaneously at a dose of 180 mg on day 1 of each 8-week cycle.

Drug: JMT103- 180 mg SC Q8W

Calcium is given orally at a dose of 500 mg at least, once daily. Vitamin D is given orally at a dose of 400 IU at least, once daily.

Dietary Supplement: Calcium Dietary Supplement: Vitamin D

Jin Li, MD

This is a randomized, open-label, dose-finding, multi-centre, phase Ⅰb study to evaluate the efficacy and safety of JMT103 in patients with bone metastases from solid tumors.

The objective of this trial is to evaluate the efficacy and safety of JMT103 in patients with bone metastases from solid tumors.

Eligible patients will be randomly assigned to receive JMT103 120mg subcutaneously (SC) every 4 weeks (Q4W), 120mg subcutaneously (SC) every 8 weeks (Q8W) and 180mg subcutaneously (SC) every 8 weeks (Q8W) in a 1:1:1 ratio. Patients will receive the treatment until the completion of 48 weeks of treatment, intolerable toxicity, loss to follow-up, withdrawal (patient's decision or investigator's decision), whichever comes first.

Efficacy and Safety of JMT103 in Patients With Bone Metastases From Solid Tumors

A Randomized, Open-Label, Dose-finding, Multi-centre, Phase Ib Study toEvaluate the Efficacy and Safety of JMT103 in Patients With Bone Metastases From Solid Tumors

SRE is defined as pathological fracture, radiotherapy to bone, surgery to bone, or spinal cord compression.

Shanghai JMT-Bio Inc.

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Denosumab

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

Xgeva®

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Safety of JMT103 in Patients With Bone Metastases From Solid Tumors	NCT04630522	Bone Metastases...	Drug: JMT103- 1... Drug: JMT103- 1... Drug: JMT103- 1... Dietary Supplem...	18 Years -	Shanghai JMT-Bio Inc.
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.
Efficacy and Safety of JMT103 in Patients With Bone Metastases From Solid Tumors	NCT04630522	Bone Metastases...	Drug: JMT103- 1... Drug: JMT103- 1... Drug: JMT103- 1... Dietary Supplem...	18 Years -	Shanghai JMT-Bio Inc.

Spots Global Cancer Trial Database for bone metastases from solid tumors