Safety, Tolerability and PK/PD of JMT103 in Patients With Bone Metastases From Tumors

Shanghai JMT-Bio

Status and phase

Unknown

Phase 1

Conditions

Bone Metastases

Treatments

Biological: Anti-RANKL Monoclonal Antibody

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT03550508

JMT103CN01

Details and patient eligibility

About

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.

Full description

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.

Enrollment

36 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

histologically or cytologically confirmed malignant solid tumors;
imaging examination shows at least one site with bone metastases from tumors;
ECOG performance status of score 0 or 1;
Expected survival time ≥ 7.5 months.

Exclusion criteria

Previous or present osteomyelitis or osteonecrosis of the jaw; unhealed dental or oral surgery wounds; acute disease of the tooth or jaw requiring oral surgery; and invasive dental surgery planned to be received during the study;
It is planned to perform therapeutic radiotherapy or orthopedic surgery for patients during the study;
Known active brain metastases or leptomeningeal metastases. The subjects with neurological symptoms should receive brain CT/MRI to ensure that there have no metastases;
Patients with bone metabolic diseases (Paget's disease, Cushing syndrome and hyperprolactinemia), rheumatoid arthritis, and current hyperparathyroidism or parathyroid dysfunction;
Uncontrolled complications
Active bacterial or fungal infections requiring systematic treatment within 7 days before the screening;
Patients with HIV infections or active hepatitis;
Pregnancy (positive serum β-HCG result) or lactation;