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

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ClinicalTrials.gov Identifier: NCT03550508
Recruitment Status : Unknown
Verified May 2018 by Shanghai JMT-Bio Inc..
Recruitment status was:  Recruiting
First Posted : June 8, 2018
Last Update Posted : June 8, 2018
Sponsor:
Collaborators:
Quintiles, Inc.
Covance
KingMed Diagnostics
Information provided by (Responsible Party):
Shanghai JMT-Bio Inc.

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Bone Metastases Biological: Anti-RANKL Monoclonal Antibody Phase 1

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: The accelerated titration and traditional "3+3" dose-escalation designs are applied in this study.
Masking: None (Open Label)
Masking Description: Open
Primary Purpose: Treatment
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
Actual Study Start Date : May 21, 2018
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Anti-RANKL Monoclonal Antibody
Anti-RANKL Monoclonal Antibody is to be injected subcutaneously 0.5 mg/kg, 1.0 mg/kg, 2.0 mg/kg or 3.0 mg/kg.
 Biological: Anti-RANKL Monoclonal Antibody
JMT103 is recombinant fully human anti-RANKL monoclonal antibody. JMT103 is provided as the injection,120 mg/vial. JMT103 was administered subcutaneously in the upper arm, upper thigh, or abdomen.
Other Name: JMT103


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Anti-Drug Antibody of Anti-RANKL Monoclonal Antibody (JMT103) in Patients With Bone Metastases From Tumors [ Time Frame: 225 days in escalation study stage, and 141 days in expansion study stage ]
  2. Maximum serum Concentration (Cmax) after single dose injection of Anti-RANKL Monoclonal Antibody (JMT103) [ Time Frame: 85 days ]
  3. Peak Time (Tmax) after single dose injection of Anti-RANKL Monoclonal Antibody (JMT103) [ Time Frame: 85 days ]
  4. Area Under the Curve (AUC) after single dose injection of Anti-RANKL Monoclonal Antibody (JMT103) [ Time Frame: 85 days ]
  5. Terminal t1/2 after single dose injection of Anti-RANKL Monoclonal Antibody (JMT103) [ Time Frame: 85 days ]
  6. Serum clearance (CL) after single dose injection of Anti-RANKL Monoclonal Antibody (JMT103) [ Time Frame: 85 days ]
  7. Apparent volume of distribution (V) after single dose injection of Anti-RANKL Monoclonal Antibody (JMT103) [ Time Frame: 85 days ]
  8. Minimum serum Concentration (Cmin) after single dose injection of Anti-RANKL Monoclonal Antibody (JMT103) [ Time Frame: 85 days ]
  9. Minimum serum Concentration (Cmin) after multiple dose injection of Anti-RANKL Monoclonal Antibody (JMT103) [ Time Frame: 141 days ]
  10. Apparent volume of distribution after multiple dose injection of Anti-RANKL Monoclonal Antibody (JMT103) [ Time Frame: 141 days ]
  11. Cumulative factor after multiple dose injection of Anti-RANKL Monoclonal Antibody (JMT103) [ Time Frame: 141 days ]
  12. Percent changes of serum C-terminal telopeptide of type 1 collagen after single dose of JMT103 [ Time Frame: 85 days ]
  13. Percent changes of bone alkaline phosphatase after single dose of JMT103 [ Time Frame: 85 days ]
  14. Percent changes of procollagen type 1 N-peptide, tartrate-resistant acid phosphatase 5b (TRAP5b) after single dose injection of Anti-RANKL Monoclonal Antibody (JMT103) [ Time Frame: 85 days ]
  15. Percent changes of urinary N-terminal telopeptide of type 1 collagen/creatine (U-NTX/Cr) after multiple doses of JMT103 [ Time Frame: 141 days ]
  16. Percent changes of serum C-terminal telopeptide of type 1 collagen after multiple doses of JMT103 [ Time Frame: 141 days ]
  17. Percent changes of bone alkaline phosphatase after multiple doses of JMT103 [ Time Frame: 141 days ]
  18. Percent changes of procollagen type 1 N-peptide, tartrate-resistant acid phosphatase 5b (TRAP5b) after multiple doses of JMT103 [ Time Frame: 141 days ]
  19. Percent changes of urinary N-terminal telopeptide of type 1 collagen/creatine (U-NTX/Cr) after multiple dose injection of Anti-RANKL Monoclonal Antibody (JMT103) [ Time Frame: 141 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03550508


Contacts
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Contact: Huiping Li, MD 86-10-88196827 huipingli2012@hotmail.com
Contact: Shukui Qin, MD 86-25-84453932 qinsk@csco.org.cn

Locations
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China
Shanghai East Hospital Recruiting
Shanghai, China, 200123
Contact: Jin Li, MD    86-21-38804518    lijin@csco.org.cn   
Sponsors and Collaborators
Shanghai JMT-Bio Inc.
Quintiles, Inc.
Covance
KingMed Diagnostics
Investigators
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Principal Investigator: Jin Li, MD Shanghai East Hospital
More Information
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Responsible Party: Shanghai JMT-Bio Inc.
ClinicalTrials.gov Identifier: NCT03550508    
Other Study ID Numbers: JMT103CN01
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai JMT-Bio Inc.:
JMT103 in Patients with Bone Metastases from Tumors
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
 Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs