Efficacy and Safety of JMT103 in Patients With Giant Cell Tumor of Bone

October 13, 2022 updated by: Shanghai JMT-Bio Inc.

A Phase Ib/II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of JMT103 in Surgically Unsalvageable or Refractory Giant Cell Tumor of Bone

This is a phase Ib/II, multicenter, single-arm, open-label study to evaluate the efficacy and safety of JMT103 in patients with surgically unsalvageable or refractory giant cell tumor of bone (GCTB).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The objective of the trial is to evaluate the efficacy and safety of JMT103 in patients with GCTB that is surgically unsalvageable or for which the planned surgery is associated with severe morbidity.

This study consists of two parts (phase Ib and II). In the phase Ib part, 6 to 12 subjects will be enrolled, and the safety, pharmacokinetics and pharmacodynamics of JMT103 will be evaluated after treatment for more than 4 weeks. And then the phase II part will be conducted, in which, 125 subjects will be enrolled.

Eligible subjects will receive JMT103 at a dose of 2mg/kg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 2mg/kg SC on study days 8 and 15 until disease progression, tumor resection (the pathologic outcome after surgical resection is CR or PR), intolerable toxicity, decision by the participant to discontinue, or decision by the investigator that the subject could no longer benefit from the treatment (whichever occurs first).

Study Type

Interventional

Enrollment (Actual)

139

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100035
        • Beijing Ji Shui Tan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Fully informed and signed informed consent.
  2. Male or female, Adults, 18 years and older
  3. Histologically confirmed GCTB that is surgically unsalvageable or for which the planned surgery is associated with severe morbidity.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.

Exclusion Criteria:

  1. Fertile subjects refuse to use effective contraception methods from the signing of the informed consent to 6 months after the last dose;
  2. Active dental or jaw condition which requires oral surgery, including tooth extraction;
  3. Currently receiving other anti-tumor therapy (radiotherapy, chemotherapy or arterial embolization, etc.);
  4. Concurrent treatment with bisphosphonates;
  5. Known history of second malignancy within the past 5 years, except for basal cell carcinoma or cervical carcinoma in situ.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: JMT103
Eligible subjects will receive JMT103 at a dose of 2 mg/kg SC Q4W with a loading dose of 2 mg/kg SC on study days 8 and 15.
Dietary supplement: Dietary Supplement: Calcium/Vitamin D
All subjects should be adequately supplemented with calcium and vitamin D (at least 500 mg of calcium and 400 IU of vitamin D), except in the case of pre-existing hypercalcemia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with Giant Cell Tumor Response
Time Frame: From enrollment until 12 weeks
A treatment response was defined for participants with tissue samples obtained and measured by histopathology as: at least 90% elimination of giant cells relative to Baseline. A response was defined for participants who have only radiographs (histopathology not available) as lack of progression of the target lesion (PR or CR) at week 12 by radiographic measurements compared with Baseline.
From enrollment until 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants with Adverse Events (AEs)
Time Frame: From enrollment until 90 days after the last dose
From enrollment until 90 days after the last dose
Objective Response Rate (ORR)
Time Frame: From enrollment until the last dose, no more than 24 months
From enrollment until the last dose, no more than 24 months
Changes in Brief Pain Inventory Short Form (BPI-SF)
Time Frame: From enrollment until the last dose, no more than 24 months
Assess pain and its effects on patients' mood, sleep, ability to move, appetite, daily life, ability to walk, and social interaction
From enrollment until the last dose, no more than 24 months
Percentage of Patients with Surgical Resection of Tumor
Time Frame: From enrollment until the last dose, no more than 24 months
From enrollment until the last dose, no more than 24 months
Serum JMT103 Trough Concentrations
Time Frame: From enrollment until 90 days after the last dose
From enrollment until 90 days after the last dose
Percent Change from Baseline in Serum C-terminus Peptide (of Type 1 Collagen) and Urinary N-telopeptide Corrected for Urine Creatinine
Time Frame: From enrollment until the last dose, no more than 24 months
From enrollment until the last dose, no more than 24 months
Number of Participants with Anti-JMT103 Antibodies
Time Frame: From enrollment until 90 days after the last dose
From enrollment until 90 days after the last dose
Disease Control Rate (DCR)
Time Frame: From enrollment until the last dose, no more than 24 months
From enrollment until the last dose, no more than 24 months
Time to Progress (TTP)
Time Frame: From enrollment until the last dose, no more than 24 months
From enrollment until the last dose, no more than 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai JMT-Bio Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2019

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

January 13, 2020

First Submitted That Met QC Criteria

February 3, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

October 14, 2022

Last Update Submitted That Met QC Criteria

October 13, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JMT103CN03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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