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

NCT03550508 | Unknown Phase 1

• 1 other identifier: JMT103CN01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Metastases

Keywords

JMT103 in Patients with Bone Metastases from Tumors

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.03

  28 days

Secondary Outcomes (19)

• Anti-Drug Antibody of Anti-RANKL Monoclonal Antibody (JMT103) in Patients With Bone Metastases From Tumors

  225 days in escalation study stage, and 141 days in expansion study stage

• Maximum serum Concentration (Cmax) after single dose injection of Anti-RANKL Monoclonal Antibody (JMT103)

  85 days

• Peak Time (Tmax) after single dose injection of Anti-RANKL Monoclonal Antibody (JMT103)

  85 days

• Area Under the Curve (AUC) after single dose injection of Anti-RANKL Monoclonal Antibody (JMT103)

  85 days

• Terminal t1/2 after single dose injection of Anti-RANKL Monoclonal Antibody (JMT103)

  85 days

Study Arms (1)

Anti-RANKL Monoclonal Antibody

EXPERIMENTAL

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

Interventions

Anti-RANKL Monoclonal Antibody BIOLOGICAL

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.

Also known as: JMT103

Anti-RANKL Monoclonal Antibody

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai JMT-Bio Inc.: lead
• Quintiles, Inc.: collaborator
• Covance: collaborator
• KingMed Diagnostics: collaborator

Study Sites (1)

Shanghai East Hospital

Shanghai, 200123, China

RECRUITING

Related Publications (1)

• Liang X, Xue J, Ge X, Li J, Li H, Xue L, Di L, Tang W, Song G, Li Q, Jiang H, Zhao W, Lin F, Shao B, Yang X, Wu Z, Zhang T, Wang C, Guo Y. Safety, tolerability, and pharmacokinetics/pharmacodynamics of JMT103 in patients with bone metastases from solid tumors. Front Oncol. 2022 Aug 5;12:971594. doi: 10.3389/fonc.2022.971594. eCollection 2022.

  PMID: 35992822 DERIVED

Study Officials

• Jin Li, MD

  Shanghai East Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huiping Li, MD

CONTACT

86-10-88196827; huipingli2012@hotmail.com

Shukui Qin, MD

CONTACT

86-25-84453932; qinsk@csco.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Open
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The accelerated titration and traditional "3+3" dose-escalation designs are applied in this study.

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: June 8, 2018
• Study Start: May 21, 2018
• Primary Completion: August 30, 2019
• Study Completion: December 1, 2019
• Last Updated: June 8, 2018

Record last verified: 2018-05

Locations

CN (1)