Spots Global Cancer Trial Database for Efficacy and Safety of JMT103 in Patients With Bone Metastases From Solid Tumors

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Trial Identification

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

Official Title: 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

Study ID: NCT04630522

Conditions

Bone Metastases From Solid Tumors

Interventions

Drug: JMT103- 120 mg SC Q4W

Drug: JMT103- 120 mg SC Q8W

Drug: JMT103- 180 mg SC Q8W

Dietary Supplement: Calcium Dietary Supplement: Vitamin D

Study Description

Brief Summary: 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.

Detailed Description: 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.