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AzTrials

Bone Metastases From Solid TumorsPhase 1NCT04630522

Efficacy and Safety of JMT103 in Patients With Bone Metastases From Solid Tumors

A Phase 1 study testing Drug: JMT103- 120 mg SC Q4W, Drug: JMT103- 120 mg SC Q8W and Drug: JMT103- 180 mg SC Q8W in people with Bone Metastases From Solid Tumors, run by Shanghai JMT-Bio Inc. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, open-label, dose-finding, multi-centre, phase Ⅰb study to evaluate the efficacy and safety of JMT103 in patients with bone metastases from solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bone Metastases From Solid Tumors
What is being tested?
Drug: JMT103- 120 mg SC Q4W, Drug: JMT103- 120 mg SC Q8W and Drug: JMT103- 180 mg SC Q8W
Could I receive a placebo?
No, everyone receives an active treatment
How many people
295 participants
Where
1 siteChina
Study dates
31 Oct 2020to 31 Mar 2023
Phase
Phase 1
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, 18 years and older.
  • Histologically/cytologically confirmed malignant solid tumors.
  • Radiographic evidence of at least one bone metastasis.
  • Eligible fertile patients (male and female) must agree to use an effective method of contraception with their partners from the signing of informed consent until at least 6 months after the last treatment.
  • Adequate organ functions.
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  • Albumin-corrected serum calcium ≥ 1 x lower limit of normal (LLN) at screening (calcium supplement is not allowed within 8 hours prior to screening).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
  • Life expectancy ≥ 6 months

Who cannot join

  • 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;
  • Radiotherapy or orthopaedic surgery is planned for patients during the study;
  • Known symptomatic brain metastases.
  • Abnormal bone metabolism (such as Paget's disease, Cushing's syndrome, hyperprolactinemia), rheumatoid arthritis, parathyroid disease
  • Clinically significant disease (such as uncontrolled diabetes, congestive heart failure, hypertension>150/90 mmHg).
  • Known hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or other active viral infection.
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  • Systemic therapy of active bacterial infection or fungal infection within 7 days prior to randomization.
  • Pregnant or lactating women.
  • Prior use of antibody against nuclear factor kappa-B (NFκB) ligand (RANKL).
  • Participated in other clinical studies and received other experimental drugs within 4 weeks prior to randomization.
  • Prior use of bisphosphonate within 4 weeks prior to randomization.
  • Prior use of one of following osteoporosis medications within 6 months prior to randomization (Parathyroid hormone (PTH) analogue, calcitonin, osteoprotegerin, mithramycin, and strontium).
  • Adverse reactions from the previous anti-tumor treatment have not yet recovered to ≤ level 1 based on CTCAE 5.0 (except for the toxicity without safety risk judged by the investigator, such as hair loss)
  • Known hypersensitivity to any of the products to be administered during the study (such as JMT103)
  • Not suitable for this study as determined by the investigator due to other reasons.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200123

Other trials in China

About this study

Official title: A Randomized, Open-Label, Dose-finding, Multi-centre, Phase Ib Study toEvaluate the Efficacy and Safety of JMT103 in Patients With Bone Metastases From Solid Tumors

This is a randomized, open-label, dose-finding, multi-centre, phase Ⅰb study to evaluate the efficacy and safety of JMT103 in patients with bone metastases from solid tumors.

Read the detailed description

The objective of this trial is to evaluate the efficacy and safety of JMT103 in patients with bone metastases from solid tumors.

Eligible patients will be randomly assigned to receive JMT103 120mg subcutaneously (SC) every 4 weeks (Q4W), 120mg subcutaneously (SC) every 8 weeks (Q8W) and 180mg subcutaneously (SC) every 8 weeks (Q8W) in a 1:1:1 ratio. Patients will receive the treatment until the completion of 48 weeks of treatment, intolerable toxicity, loss to follow-up, withdrawal (patient's decision or investigator's decision), whichever comes first.

Being tested
Drug: JMT103- 120 mg SC Q4W, Drug: JMT103- 120 mg SC Q8W, Drug: JMT103- 180 mg SC Q8W, Dietary Supplement: Calcium Dietary Supplement: Vitamin D

What participants receive

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

  • Drug: JMT103- 120 mg SC Q4WDrug

    JMT103 is administered subcutaneously at a dose of 120 mg on day 1 of each 4-week cycle.

  • Drug: JMT103- 120 mg SC Q8WDrug

    JMT103 is administered subcutaneously at a dose of 120 mg on day 1 of each 8-week cycle.

  • Drug: JMT103- 180 mg SC Q8WDrug

    JMT103 is administered subcutaneously at a dose of 180 mg on day 1 of each 8-week cycle.

  • Dietary Supplement: Calcium Dietary Supplement: Vitamin DDietary supplement

    Calcium is given orally at a dose of 500 mg at least, once daily. Vitamin D is given orally at a dose of 400 IU at least, once daily.

Study groups in NCT04630522
Study groupRoleWhat they receive
JMT103- 120 mg SC Q4WExperimentalEligible patients will receive JMT103 120 mg SC Q4W for up to 13 cycles.
Receives: Drug: Drug: JMT103- 120 mg SC Q4W; Dietary Supplement: Dietary Supplement: Calcium Dietary Supplement: Vitamin D
JMT103- 120 mg SC Q8WExperimentalEligible patients will receive JMT103 120 mg SC Q8W for up to 7 cycles.
Receives: Drug: Drug: JMT103- 120 mg SC Q8W; Dietary Supplement: Dietary Supplement: Calcium Dietary Supplement: Vitamin D
JMT103- 180 mg SC Q8WExperimentalEligible patients will receive JMT103 180 mg SC Q8W for up to 7 cycles.
Receives: Drug: Drug: JMT103- 180 mg SC Q8W; Dietary Supplement: Dietary Supplement: Calcium Dietary Supplement: Vitamin D

What is being measured

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

  1. Percentage change of urinary N-terminal telopeptide of type 1 collagen/creatine (U-NTX/Cr) from baseline to week 13

    Measured: From enrollment to week 13.

Secondary outcomes (7)

  1. Incidence and type of adverse events (AEs)

    Measured: From enrollment to 90 days after the last dose

  2. Incidence of Skeletal-related event（SRE）

    SRE is defined as pathological fracture, radiotherapy to bone, surgery to bone, or spinal cord compression.

    Measured: From enrollment to 90 days after the last dose

  3. Change in Pain Score (Brief Pain Inventory-Short Form，BPI-SF)

    Measured: From enrollment to 90 days after the last dose

  4. Trough plasma concentration （Ctrough）

    Measured: From enrollment to 90 days after the last dose

  5. Percentage change in serum C-terminus peptide (of Type 1 Collagen) from baseline

    Measured: From enrollment to 90 days after the last dose

  6. Percentage change in serum bone-specific alkaline phosphatase (bALP) from baseline

    Measured: From enrollment to 90 days after the last dose

  7. Number of patients with anti-JMT103 antibodies

    Measured: From enrollment to 90 days after the last dose

Timeline

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

  1. First posted16 Nov 2020
  2. Study start31 Oct 2020
  3. Primary completion31 Mar 2023
  4. Study completion31 Mar 2023

Resources

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
295 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04630522
Sponsor's protocol ID
JMT103CN01-1
Status last verified
Nov 2023
First submitted
2 Nov 2020
Last updated
9 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Ran R, Li H, Sun T, Zhou H, Zang A, Guo H, Xie H, Wu S, Yan Y, Yin X, Xiong H, Li H, Yuan J, Wang J, Li H, Li J. Efficacy and safety of JMT103 in patients with bone metastases from solid tumors: A randomized Phase Ib clinical trial. Int J Cancer. 2025 Jun 1;156(11):2178-2187. doi: 10.1002/ijc.35343. Epub 2025 Jan 23.

    PubMed 39853667

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Drug: JMT103- 120 mg SC Q4W, Drug: JMT103- 120 mg SC Q8W and Drug: JMT103- 180 mg SC Q8W in people with Bone Metastases From Solid Tumors, 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 9 inclusion and 15 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: finished, as of the sponsor's last update on 9 Nov 2023. 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 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.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 change of urinary N-terminal telopeptide of type 1 collagen/creatine (U-NTX/Cr) from baseline to week 13 (time frame: From enrollment to week 13.). 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 NCT04630522, which also lists 1 linked publication.

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 9 Nov 2023.

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