Imaging Examination Shows at Least One Site With Bone Metastases From Soild TumorsPhase 3NCT06221072
A Study to Assess the Prevention of Bone-related Events in Patients With Bone Metastases From Malignant Solid Tumors Treated With JMT103 Compared to Zoledronic Acid
A Phase 3 study testing JMT103 and zoledronic acid in people with Imaging Examination Shows at Least One Site With Bone Metastases From Soild Tumors, run by Shanghai JMT-Bio Inc..
Trial summary
This is a phase Ⅲ, multicenter, randomized, double-blind, study to evaluate the efficacy and safety of JMT103 in patients with bone metastases from malignant solid tumors. The purpose of this study is to determine if JMT103 is non-inferior to zoledronic acid. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Imaging Examination Shows at Least One Site With Bone Metastases From Soild Tumors
- What is being tested?
- JMT103 and zoledronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,360 participants
- Where
- No sites listed yet
- Study dates
- 5 Apr 2024to 31 May 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Age: older than 18 years;
- Breast cancer, prostate cancer, lung cancer and other solid tumors diagnosed by histological or cytological examination (prostate patients should also meet: castration-resistant prostate cancer with serum testosterone <50 ng/dL or 1.7 nmol/L and serum PSA progression after surgery or drug castration treatment);
- Patients with imaging studies showing at least one tumor bone metastasis;
- With a good organ function;
- Expected survival of at least 6 months.
Who cannot join
- Previous or ongoing osteomyelitis or osteonecrosis of the jaw; dental or oral surgery; acute dental or jaw disease requiring oral surgery; invasive dental procedures planned during the study; patients with pulpitis during the screening period;
- Radiotherapy or surgery for the bone metastases is planned during the study;
- Patients with brain metastasis or meningeal metastasis (patients with neurological symptoms should undergo MRI/CT examination to exclude patients with brain metastasis);
- Patients with bone metabolic diseases [e.g., Paget's disease, Cushing's syndrome, hyperprolactinemia, hyperthyroidism/hypothyroid (except for hypothyroidism with normal TSH, FT3, and FT4 after stable thyroid hormone replacement therapy, and subclinical hypothyroidism that does not need to be treated), hyper/hypoparathyroidism, etc.];
- Uncontrolled concurrent diseases, including but not limited to: uncontrolled diabetes mellitus (≥grade 3, NCI-CTCAE 5.0), symptomatic congestive heart failure, hypertension (BP> 150/90 mmHg after standard therapy), unstable angina, arrhythmia requiring medical or instrumental treatment, history of myocardial infarction within 6 months, echocardiography with left ventricular ejection fraction <50%;
- Treatment with anti-RANKL antibody, bisphosphonates (except for bone scan purposes) within 6 months prior to the first dose;
- Patients considered by the investigator as unsuitable for this study (such as poor compliance, etc.).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase III, Multicenter, Randomized, Double-blind Clinical Trail to Assess JMT103 Compared to Azoledronic Acid for the Prevention of Bone-related Events in Patients With Bone Metastases From Malignant Solid Tumors
This is a phase Ⅲ, multicenter, randomized, double-blind, study to evaluate the efficacy and safety of JMT103 in patients with bone metastases from malignant solid tumors. The purpose of this study is to determine if JMT103 is non-inferior to zoledronic acid.
- Being tested
- JMT103, zoledronic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMT103Drug
120 mg by subcutaneous injection every 4 weeks
zoledronic acidDrug
4 mg by intravenous drip (100mL:4mg) every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group 1-JMT103 | Experimental | Participants will receive JMT103 and zoledronic acid placebo. Receives: Drug: JMT103 |
| Group 2-zoledronic acid | Experimental | Participants will receive zoledronic acid and JMT103 placebo. Receives: Drug: zoledronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the First on-study Skeletal-Related Event (SRE)
Measured: Up to approximately 48 months
Secondary outcomes (7)
Time to First and Subsequent SRE (21 days from the last SRE is subsequent SRE)
Measured: Up to approximately 48 months
Percent change from baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (NTx/Cr)
Measured: Up to approximately 28 months
Quality of life score (concise pain assessment Scale and EQ-5D-5L scale);
Measured: Up to approximately 48 months
Incidence and severity of adverse events (AEs)
Measured: Up to approximately 48 months
JMT103 The incidence of injection anti-drug antibodies (ADA) and neutralizing antibodies (Nab)
Measured: Up to approximately 48 months
Serum concentration of JMT103
Measured: Up to approximately 48 months
Overall survival (OS)
Measured: Up to approximately 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start5 Apr 2024 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Imaging Examination Shows at Least One Site With Bone Metastases From Soild TumorsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicenter, randomized, double-blind clinical Trail
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai JMT-Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221072
- Sponsor's protocol ID
- JMT103-012
- Status last verified
- Jan 2024
- First submitted
- 14 Jan 2024
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Randomized, Double-blind Clinical Trail to Assess JMT103 Compared to Azoledronic Acid for the Prevention of Bone-related Events in Patients With Bone Metastases From Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT06221072
- Acronym / sponsor ID
- JMT103-012
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,360 participants (estimated)
- Lead sponsor
- Shanghai JMT-Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Apr 2024 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 24 Jan 2024 (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 Ⅲ, multicenter, randomized, double-blind, study to evaluate the efficacy and safety of JMT103 in patients with bone metastases from malignant solid tumors. The purpose of this study is to determine if JMT103 is non-inferior to zoledronic acid.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- multicenter, randomized, double-blind clinical Trail
| Arm | Type | Receives |
|---|---|---|
| Group 1-JMT103 | Experimental | Drug: JMT103Participants will receive JMT103 and zoledronic acid placebo. |
| Group 2-zoledronic acid | Experimental | Drug: zoledronic acidParticipants will receive zoledronic acid and JMT103 placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: older than 18 years;
- Breast cancer, prostate cancer, lung cancer and other solid tumors diagnosed by histological or cytological examination (prostate patients should also meet: castration-resistant prostate cancer with serum testosterone <50 ng/dL or 1.7 nmol/L and serum PSA progression after surgery or drug castration treatment);
- Patients with imaging studies showing at least one tumor bone metastasis;
- With a good organ function;
- Expected survival of at least 6 months.
Key exclusion criteria (7 listed)
- Previous or ongoing osteomyelitis or osteonecrosis of the jaw; dental or oral surgery; acute dental or jaw disease requiring oral surgery; invasive dental procedures planned during the study; patients with pulpitis during the screening period;
- Radiotherapy or surgery for the bone metastases is planned during the study;
- Patients with brain metastasis or meningeal metastasis (patients with neurological symptoms should undergo MRI/CT examination to exclude patients with brain metastasis);
- Patients with bone metabolic diseases [e.g., Paget's disease, Cushing's syndrome, hyperprolactinemia, hyperthyroidism/hypothyroid (except for hypothyroidism with normal TSH, FT3, and FT4 after stable thyroid hormone replacement therapy, and subclinical hypothyroidism that does not need to be treated), hyper/hypoparathyroidism, etc.];
- Uncontrolled concurrent diseases, including but not limited to: uncontrolled diabetes mellitus (≥grade 3, NCI-CTCAE 5.0), symptomatic congestive heart failure, hypertension (BP> 150/90 mmHg after standard therapy), unstable angina, arrhythmia requiring medical or instrumental treatment, history of myocardial infarction within 6 months, echocardiography with left ventricular ejection fraction <50%;
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 |
|---|---|---|
| JMT103120 mg by subcutaneous injection every 4 weeks | Drug | Group 1-JMT103 |
| zoledronic acid4 mg by intravenous drip (100mL:4mg) every 4 weeks | Drug | Group 2-zoledronic acid |
Primary outcome
Time to the First on-study Skeletal-Related Event (SRE)
Time frame: Up to approximately 48 months
7 secondary outcomes
Time to First and Subsequent SRE (21 days from the last SRE is subsequent SRE)
Time frame: Up to approximately 48 months
Percent change from baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (NTx/Cr)
Time frame: Up to approximately 28 months
Quality of life score (concise pain assessment Scale and EQ-5D-5L scale);
Time frame: Up to approximately 48 months
Incidence and severity of adverse events (AEs)
Time frame: Up to approximately 48 months
JMT103 The incidence of injection anti-drug antibodies (ADA) and neutralizing antibodies (Nab)
Time frame: Up to approximately 48 months
Serum concentration of JMT103
Time frame: Up to approximately 48 months
Overall survival (OS)
Time frame: Up to approximately 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JMT103 and zoledronic acid in people with Imaging Examination Shows at Least One Site With Bone Metastases From Soild Tumors, run by Shanghai JMT-Bio Inc..
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to the First on-study Skeletal-Related Event (SRE) (time frame: Up to approximately 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2024.