Bone Metastases Clinical Trial
Official title:
A Phase I, Multi-center, Open-label, Dose Escalation Study to Evaluate the Safety, Tolerability and Preliminary Pharmacokinetics/Pharmacodynamics of JMT103 in Patients With Bone Metastases From Tumors
JMT103 is a novel, full human IgG4 monoclonal antibody targeting RANKL. In preclinical
studies, JMT103 demonstrated strong activity through blocking RANKL receptor, RANK on the
surface of osteoclasts, leading to inhibit osteoclast differentiation, activation, and
maturation and reduce bone resorption.
This first-in-human study is conducted to assess the maximum tolerated dose (MTD) and
dose-limiting toxicity (DLT) ,to evaluate the safety, pharmacokinetics and preliminary
efficacy (bone turnover markers) of recombinant fully human Anti-RANKL Monoclonal Antibody
(JMT103) in patients with bone metastases from tumors at single doses and multiple doses.
About 36 cases patients are to be recruited.
This is a Phase I, first-in-human, multi-center, open-label dose escalation clinical study of
recombinant fully human Anti-RANKL Monoclonal Antibody (JMT103) administered subcutaneously
to patients with bone metastases from tumors.
The study includes two phases: dose escalation study and expansion study. The dose-escalation
stage is designed to evaluate the safety, tolerability, and pharmacokinetics of single dose
and following repeat doses of JMT103 given every 4 weeks (Q4W) for three times. The expansion
study stage is designed to evaluate the safety, tolerability, and pharmacokinetics of repeat
doses of JMT103 given every 4 weeks (Q4W) for three times.
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