For Healthcare Professionals

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

clipboard-pencil

About the study

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.
user-3

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

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

EXCLUSION CRITERIA

  1. 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;
  2. It is planned to perform therapeutic radiotherapy or orthopedic surgery for patients during the study;
  3. Known active brain metastases or leptomeningeal metastases. The subjects with neurological symptoms should receive brain CT/MRI to ensure that there have no metastases;
  4. Patients with bone metabolic diseases (Paget's disease, Cushing syndrome and hyperprolactinemia), rheumatoid arthritis, and current hyperparathyroidism or parathyroid dysfunction;
  5. Uncontrolled complications
  6. Active bacterial or fungal infections requiring systematic treatment within 7 days before the screening;
  7. Patients with HIV infections or active hepatitis;
  8. Pregnancy (positive serum β-HCG result) or lactation;
pin location

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 86-10-88196827Email iconEmail Study Center

Study’s details


Contition

Bone Metastases

Age (in years)

18 - 75

Phase

Phase 1

Participants needed

36

Est. Completion Date

Dec 2019

Treatment type

Interventional


Sponsor

Shanghai JMT-Bio Inc.

ClinicalTrials.gov identifier

NCT03550508

Study number

JMT103CN01

Understanding Clinical Trials


Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?
Vector

Interested?

Sign up to save your favorites, 
receive newsletters, resources, and alerts 
about clinical trials related to your conditions of interest.