Giant Cell Tumor of BonePhase 1/2NCT04255576

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

A Phase 1/2 study testing Dietary Supplement: Calcium/Vitamin D in people with Giant Cell Tumor of Bone, run by Shanghai JMT-Bio Inc. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Giant Cell Tumor of Bone
What is being tested?: Dietary Supplement: Calcium/Vitamin D
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 139 participants
Where: 1 siteChina
Study dates: 10 Oct 2019to Oct 2023
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Ji Shui Tan Hospital
Beijing, 100035

Other trials in China

About this study

Official title: 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).

Read the 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).

Conditions: Giant Cell Tumor of Bone
Being tested: Dietary Supplement: Calcium/Vitamin D
Medical subject headings: Giant Cell Tumor of Bone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dietary Supplement: Calcium/Vitamin DDietary supplement
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.

Study groups in NCT04255576
Study group	Role	What they receive
Experimental: JMT103	Experimental	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. Receives: Dietary Supplement: Dietary Supplement: Calcium/Vitamin D

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants with Giant Cell Tumor Response
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.
Measured: From enrollment until 12 weeks

Secondary outcomes (9)

Proportion of Participants with Adverse Events (AEs)
Measured: From enrollment until 90 days after the last dose
Objective Response Rate (ORR)
Measured: From enrollment until the last dose, no more than 24 months
Changes in Brief Pain Inventory Short Form (BPI-SF)
Assess pain and its effects on patients' mood, sleep, ability to move, appetite, daily life, ability to walk, and social interaction
Measured: From enrollment until the last dose, no more than 24 months
Percentage of Patients with Surgical Resection of Tumor
Measured: From enrollment until the last dose, no more than 24 months
Serum JMT103 Trough Concentrations
Measured: 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
Measured: From enrollment until the last dose, no more than 24 months
Number of Participants with Anti-JMT103 Antibodies
Measured: From enrollment until 90 days after the last dose
Disease Control Rate (DCR)
Measured: From enrollment until the last dose, no more than 24 months
Time to Progress (TTP)
Measured: From enrollment until the last dose, no more than 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Oct 2019Oct 2023

First posted5 Feb 2020
Study start10 Oct 2019
Primary completionSep 2023 (estimated)
Study completionOct 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Giant Cell Tumor of BoneStudies of the same condition, open and under way.
More trials run by Shanghai JMT-Bio Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 139 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04255576
Sponsor's protocol ID: JMT103CN03
Status last verified: Oct 2022
First submitted: 13 Jan 2020
Last updated: 14 Oct 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Xu H, Zhou Y, Wei F, Ding Y, Shan H, Yang Y, Liu W, Jin T, Luo Y, Tang F, Lu M, He X, Zhang W, Yang S, Zhang L, Wang J, Li H, Tu C, Niu X. JMT103 versus Non-Denosumab or Denosumab Treatment in Chinese Patients with Unresectable or Surgically Challenging Giant Cell Tumor of Bone: A Propensity Score-Matched Comparison. Cancer Med. 2025 Nov;14(22):e71340. doi: 10.1002/cam4.71340.
PubMed 41292259
Xu H, Zhou Y, Liang L, Shen J, Yan W, Wang J, Li J, Zhang X, Huang G, Bi W, Guo Z, Xiao Y, Lin J, Yao W, Tong Z, Zhou W, Zhang G, Ye Z, Wang D, Yang J, Fan Z, Liu C, Qu G, Zhang Q, Wei F, Liu W, Tu C, Li H, Yuan J, Niu X. Efficacy and safety of JMT103 in patients with unresectable or surgically-challenging giant cell tumor of bone: a multicenter, phase Ib/II study. Nat Commun. 2024 Nov 5;15(1):9541. doi: 10.1038/s41467-024-53686-4.
PubMed 39500883

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Giant Cell Tumor of Bone trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04255576
Acronym / sponsor ID: JMT103CN03
Conditions: Giant Cell Tumor of Bone
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 139 participants (actual)
Lead sponsor: Shanghai JMT-Bio Inc.Industry (pharma, biotech, devices)
Study start: 10 Oct 2019 (actual)
Primary completion: Sep 2023 (estimated)
Study completion: Oct 2023 (estimated)
First posted: 5 Feb 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Experimental: JMT103	Experimental	Dietary Supplement: Dietary Supplement: Calcium/Vitamin DEligible 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dietary Supplement: Calcium/Vitamin DAll 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.	Dietary supplement	Experimental: JMT103

Primary outcome

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.

9 secondary outcomes

Proportion of Participants with Adverse Events (AEs)
Time frame: 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
Changes in Brief Pain Inventory Short Form (BPI-SF)
Time frame: 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
Serum JMT103 Trough Concentrations
Time frame: 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
Number of Participants with Anti-JMT103 Antibodies
Time frame: 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
Time to Progress (TTP)
Time frame: From enrollment until the last dose, no more than 24 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
Derived from this study: PubMed 41292259Xu H, Zhou Y, Wei F, Ding Y, Shan H, Yang Y, Liu W, Jin T, Luo Y, Tang F, Lu M, He X, Zhang W, Yang S, Zhang L, Wang J, Li H, Tu C, Niu X. JMT103 versus Non-Denosumab or Denosumab Treatment in Chinese Patients with Unresectable or Surgically Challenging Giant Cell Tumor of Bone: A Propensity Score-Matched Comparison. Cancer Med. 2025 Nov;14(22):e71340. doi: 10.1002/cam4.71340.
Derived from this study: PubMed 39500883Xu H, Zhou Y, Liang L, Shen J, Yan W, Wang J, Li J, Zhang X, Huang G, Bi W, Guo Z, Xiao Y, Lin J, Yao W, Tong Z, Zhou W, Zhang G, Ye Z, Wang D, Yang J, Fan Z, Liu C, Qu G, Zhang Q, Wei F, Liu W, Tu C, Li H, Yuan J, Niu X. Efficacy and safety of JMT103 in patients with unresectable or surgically-challenging giant cell tumor of bone: a multicenter, phase Ib/II study. Nat Commun. 2024 Nov 5;15(1):9541. doi: 10.1038/s41467-024-53686-4.

Related trials for Giant Cell Tumor of Bone

RecruitingObservational study
Activation Sarcoma: PROMIS and Mobility Evaluation in Sarcoma Patients
Sarcoma, Giant Cell Tumor of Bone
RecruitingObservational study
InAdvance: Surveillance, Prevention, and Interception in a Population at Risk for Cancer
Cancer Risk, Cancer Predisposition Syndrome
RecruitingPhase 1/2
NRSTS2021, A Risk Adapted Study Evaluating Maintenance Pazopanib, Limited Margin, Dose-Escalated Radiation Therapy and Selinexor in Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)
Adipocytic Neoplasm, Liposarcoma
RecruitingObservational study
TRACP-5b for Diagnosis and Follow-up of Giant Cell Tumor of Bone
Giant Cell Tumor of Bone, TRACP-5b
Active, not recruitingPhase 2
LN-145 or LN-145-S1 in Treating Patients With Relapsed or Refractory Ovarian Cancer, Triple Negative Breast Cancer (TNBC), Anaplastic Thyroid Cancer, Osteosarcoma, or Other Bone and Soft Tissue Sarcomas
Bone Sarcoma, Dedifferentiated Chondrosarcoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Dietary Supplement: Calcium/Vitamin D in people with Giant Cell Tumor of Bone, run by Shanghai JMT-Bio Inc. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with Giant Cell Tumor Response (time frame: From enrollment until 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04255576, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.