Bone MetastasesPhase 1JMT103NCT03550508
Safety, Tolerability and PK/PD of JMT103 in Patients With Bone Metastases From Tumors
A Phase 1 study testing Anti-RANKL Monoclonal Antibody in people with Bone Metastases, run by Shanghai JMT-Bio Inc. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bone Metastases
- What is being tested?
- Anti-RANKL Monoclonal Antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 21 May 2018to 1 Dec 2019
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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;
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital
Shanghai, 200123
Jin Li, MD, 86-21-38804518, lijin@csco.org.cn
About this study
Official title: A Phase I, Multi-center, Open-label, Dose Escalation Study to Evaluate the Safety, Tolerability and Preliminary Pharmacokinetics/Pharmacodynamics of JMT103 in Patients With Bone Metastases From Tumors
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.
Read the detailed description
This is a Phase I, first-in-human, multi-center, open-label dose escalation clinical study of recombinant fully human Anti-RANKL Monoclonal Antibody (JMT103) administered subcutaneously to patients with bone metastases from tumors.
The study includes two phases: dose escalation study and expansion study. The dose-escalation stage is designed to evaluate the safety, tolerability, and pharmacokinetics of single dose and following repeat doses of JMT103 given every 4 weeks (Q4W) for three times. The expansion study stage is designed to evaluate the safety, tolerability, and pharmacokinetics of repeat doses of JMT103 given every 4 weeks (Q4W) for three times.
- Conditions
- Bone Metastases
- Being tested
- Anti-RANKL Monoclonal Antibody
- Keywords
- JMT103 in Patients with Bone Metastases from Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-RANKL Monoclonal AntibodyBiological
Also called JMT103
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Anti-RANKL Monoclonal Antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Measured: 28 days
Secondary outcomes (19)
Anti-Drug Antibody of Anti-RANKL Monoclonal Antibody (JMT103) in Patients With Bone Metastases From Tumors
Measured: 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)
Measured: 85 days
Peak Time (Tmax) after single dose injection of Anti-RANKL Monoclonal Antibody (JMT103)
Measured: 85 days
Area Under the Curve (AUC) after single dose injection of Anti-RANKL Monoclonal Antibody (JMT103)
Measured: 85 days
Terminal t1/2 after single dose injection of Anti-RANKL Monoclonal Antibody (JMT103)
Measured: 85 days
Serum clearance (CL) after single dose injection of Anti-RANKL Monoclonal Antibody (JMT103)
Measured: 85 days
Apparent volume of distribution (V) after single dose injection of Anti-RANKL Monoclonal Antibody (JMT103)
Measured: 85 days
Minimum serum Concentration (Cmin) after single dose injection of Anti-RANKL Monoclonal Antibody (JMT103)
Measured: 85 days
Minimum serum Concentration (Cmin) after multiple dose injection of Anti-RANKL Monoclonal Antibody (JMT103)
Measured: 141 days
Apparent volume of distribution after multiple dose injection of Anti-RANKL Monoclonal Antibody (JMT103)
Measured: 141 days
Cumulative factor after multiple dose injection of Anti-RANKL Monoclonal Antibody (JMT103)
Measured: 141 days
Percent changes of serum C-terminal telopeptide of type 1 collagen after single dose of JMT103
Measured: 85 days
Percent changes of bone alkaline phosphatase after single dose of JMT103
Measured: 85 days
Percent changes of procollagen type 1 N-peptide, tartrate-resistant acid phosphatase 5b (TRAP5b) after single dose injection of Anti-RANKL Monoclonal Antibody (JMT103)
Measured: 85 days
Percent changes of urinary N-terminal telopeptide of type 1 collagen/creatine (U-NTX/Cr) after multiple doses of JMT103
Measured: 141 days
Percent changes of serum C-terminal telopeptide of type 1 collagen after multiple doses of JMT103
Measured: 141 days
Percent changes of bone alkaline phosphatase after multiple doses of JMT103
Measured: 141 days
Percent changes of procollagen type 1 N-peptide, tartrate-resistant acid phosphatase 5b (TRAP5b) after multiple doses of JMT103
Measured: 141 days
Percent changes of urinary N-terminal telopeptide of type 1 collagen/creatine (U-NTX/Cr) after multiple dose injection of Anti-RANKL Monoclonal Antibody (JMT103)
Measured: 141 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start21 May 2018
- Primary completion30 Aug 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone MetastasesStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The accelerated titration and traditional "3+3" dose-escalation designs are applied in this study.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai JMT-Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc., Covance, KingMed Diagnostics
- Responsible party
- Sponsor
- Investigators
- Jin Li, MD, Principal investigator, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550508
- Sponsor's protocol ID
- JMT103CN01
- Acronym
- JMT103
- Status last verified
- May 2018
- First submitted
- 18 Apr 2018
- Last updated
- 8 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35992822
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multi-center, Open-label, Dose Escalation Study to Evaluate the Safety, Tolerability and Preliminary Pharmacokinetics/Pharmacodynamics of JMT103 in Patients With Bone Metastases From Tumors
- ClinicalTrials.gov ID
- NCT03550508
- Acronym / sponsor ID
- JMT103 / JMT103CN01
- Conditions
- Bone Metastases
- Keywords
- JMT103 in Patients with Bone Metastases from Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Shanghai JMT-Bio Inc.Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc., Covance, KingMed Diagnostics
- Study start
- 21 May 2018 (actual)
- Primary completion
- 30 Aug 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 8 Jun 2018 (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.
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.
Detailed description
This is a Phase I, first-in-human, multi-center, open-label dose escalation clinical study of recombinant fully human Anti-RANKL Monoclonal Antibody (JMT103) administered subcutaneously to patients with bone metastases from tumors.
The study includes two phases: dose escalation study and expansion study. The dose-escalation stage is designed to evaluate the safety, tolerability, and pharmacokinetics of single dose and following repeat doses of JMT103 given every 4 weeks (Q4W) for three times. The expansion study stage is designed to evaluate the safety, tolerability, and pharmacokinetics of repeat doses of JMT103 given every 4 weeks (Q4W) for three times.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The accelerated titration and traditional "3+3" dose-escalation designs are applied in this study.
| Arm | Type | Receives |
|---|---|---|
| Anti-RANKL Monoclonal Antibody | Experimental | Biological: Anti-RANKL Monoclonal AntibodyAnti-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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Anti-RANKL Monoclonal AntibodyAlso: JMT103JMT103 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. | Biological | Anti-RANKL Monoclonal Antibody |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Time frame: 28 days
19 secondary outcomes
Anti-Drug Antibody of Anti-RANKL Monoclonal Antibody (JMT103) in Patients With Bone Metastases From Tumors
Time frame: 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)
Time frame: 85 days
Peak Time (Tmax) after single dose injection of Anti-RANKL Monoclonal Antibody (JMT103)
Time frame: 85 days
Area Under the Curve (AUC) after single dose injection of Anti-RANKL Monoclonal Antibody (JMT103)
Time frame: 85 days
Terminal t1/2 after single dose injection of Anti-RANKL Monoclonal Antibody (JMT103)
Time frame: 85 days
Serum clearance (CL) after single dose injection of Anti-RANKL Monoclonal Antibody (JMT103)
Time frame: 85 days
Apparent volume of distribution (V) after single dose injection of Anti-RANKL Monoclonal Antibody (JMT103)
Time frame: 85 days
Minimum serum Concentration (Cmin) after single dose injection of Anti-RANKL Monoclonal Antibody (JMT103)
Time frame: 85 days
Minimum serum Concentration (Cmin) after multiple dose injection of Anti-RANKL Monoclonal Antibody (JMT103)
Time frame: 141 days
Apparent volume of distribution after multiple dose injection of Anti-RANKL Monoclonal Antibody (JMT103)
Time frame: 141 days
Cumulative factor after multiple dose injection of Anti-RANKL Monoclonal Antibody (JMT103)
Time frame: 141 days
Percent changes of serum C-terminal telopeptide of type 1 collagen after single dose of JMT103
Time frame: 85 days
Percent changes of bone alkaline phosphatase after single dose of JMT103
Time frame: 85 days
Percent changes of procollagen type 1 N-peptide, tartrate-resistant acid phosphatase 5b (TRAP5b) after single dose injection of Anti-RANKL Monoclonal Antibody (JMT103)
Time frame: 85 days
Percent changes of urinary N-terminal telopeptide of type 1 collagen/creatine (U-NTX/Cr) after multiple doses of JMT103
Time frame: 141 days
Percent changes of serum C-terminal telopeptide of type 1 collagen after multiple doses of JMT103
Time frame: 141 days
Percent changes of bone alkaline phosphatase after multiple doses of JMT103
Time frame: 141 days
Percent changes of procollagen type 1 N-peptide, tartrate-resistant acid phosphatase 5b (TRAP5b) after multiple doses of JMT103
Time frame: 141 days
Percent changes of urinary N-terminal telopeptide of type 1 collagen/creatine (U-NTX/Cr) after multiple dose injection of Anti-RANKL Monoclonal Antibody (JMT103)
Time frame: 141 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2018.
- Derived from this study: PubMed 35992822Liang 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.
- Individual participant dataSharing planned: Undecided
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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.
Jin Li, MD principal investigator
Shanghai East Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Anti-RANKL Monoclonal Antibody in people with Bone Metastases, 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 8 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 8 Jun 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huiping Li, MD (86-10-88196827, huipingli2012@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 (time frame: 28 days). 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 NCT03550508, 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 8 Jun 2018.