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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04630522
Recruitment Status : Recruiting
First Posted : November 16, 2020
Last Update Posted : November 16, 2020
Sponsor:
Information provided by (Responsible Party):
Shanghai JMT-Bio Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Bone Metastases From Solid Tumors Drug: Drug: JMT103- 120 mg SC Q4W Drug: Drug: JMT103- 120 mg SC Q8W Drug: Drug: JMT103- 180 mg SC Q8W Dietary Supplement: Dietary Supplement: Calcium Dietary Supplement: Vitamin D Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 31, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : May 31, 2022

Arm Intervention/treatment
Experimental: JMT103- 120 mg SC Q4W
Eligible patients will receive JMT103 120 mg SC Q4W for up to 13 cycles.
Drug: Drug: JMT103- 120 mg SC Q4W
JMT103 is administered subcutaneously at a dose of 120 mg on day 1 of each 4-week cycle.

Dietary Supplement: Dietary Supplement: Calcium Dietary Supplement: Vitamin D
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.

Experimental: JMT103- 120 mg SC Q8W
Eligible patients will receive JMT103 120 mg SC Q8W for up to 7 cycles.
Drug: Drug: JMT103- 120 mg SC Q8W
JMT103 is administered subcutaneously at a dose of 120 mg on day 1 of each 8-week cycle.

Dietary Supplement: Dietary Supplement: Calcium Dietary Supplement: Vitamin D
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.

Experimental: JMT103- 180 mg SC Q8W
Eligible patients will receive JMT103 180 mg SC Q8W for up to 7 cycles.
Drug: Drug: JMT103- 180 mg SC Q8W
JMT103 is administered subcutaneously at a dose of 180 mg on day 1 of each 8-week cycle.

Dietary Supplement: Dietary Supplement: Calcium Dietary Supplement: Vitamin D
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.




Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. Incidence and type of adverse events (AEs) [ Time Frame: From enrollment to 90 days after the last dose ]
  2. Incidence of Skeletal-related event(SRE) [ Time Frame: From enrollment to 90 days after the last dose ]
    SRE is defined as pathological fracture, radiotherapy to bone, surgery to bone, or spinal cord compression.

  3. Change in Pain Score (Brief Pain Inventory-Short Form,BPI-SF) [ Time Frame: From enrollment to 90 days after the last dose ]
  4. Trough plasma concentration (Ctrough) [ Time Frame: From enrollment to 90 days after the last dose ]
  5. Percentage change in serum C-terminus peptide (of Type 1 Collagen) from baseline [ Time Frame: From enrollment to 90 days after the last dose ]
  6. Percentage change in serum bone-specific alkaline phosphatase (bALP) from baseline [ Time Frame: From enrollment to 90 days after the last dose ]
  7. Number of patients with anti-JMT103 antibodies [ Time Frame: From enrollment to 90 days after the last dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Fully informed and signed informed consent.
  2. Male or female, 18 years and older.
  3. Histologically/cytologically confirmed malignant solid tumors.
  4. Radiographic evidence of at least one bone metastasis.
  5. 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.
  6. Adequate organ functions.
  7. Albumin-corrected serum calcium ≥ 1 x lower limit of normal (LLN) at screening (calcium supplement is not allowed within 8 hours prior to screening).
  8. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
  9. Life expectancy ≥ 6 months

Exclusion Criteria:

  1. 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;
  2. Radiotherapy or orthopaedic surgery is planned for patients during the study;
  3. Known symptomatic brain metastases.
  4. Abnormal bone metabolism (such as Paget's disease, Cushing's syndrome, hyperprolactinemia), rheumatoid arthritis, parathyroid disease
  5. Clinically significant disease (such as uncontrolled diabetes, congestive heart failure, hypertension>150/90 mmHg).
  6. Known hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or other active viral infection.
  7. Systemic therapy of active bacterial infection or fungal infection within 7 days prior to randomization.
  8. Pregnant or lactating women.
  9. Prior use of antibody against nuclear factor kappa-B (NFκB) ligand (RANKL).
  10. Participated in other clinical studies and received other experimental drugs within 4 weeks prior to randomization.
  11. Prior use of bisphosphonate within 4 weeks prior to randomization.
  12. Prior use of one of following osteoporosis medications within 6 months prior to randomization (Parathyroid hormone (PTH) analogue, calcitonin, osteoprotegerin, mithramycin, and strontium).
  13. 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)
  14. Known hypersensitivity to any of the products to be administered during the study (such as JMT103)
  15. Not suitable for this study as determined by the investigator due to other reasons.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04630522


Contacts
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Contact: Jin Li, MD 86-21-38804518 lijin@csco.org.cn
Contact: Huiping Li, MD 86-10-88196827 huipingli2012@hotmail.com

Locations
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China, Shanghai
Shanghai East Hospital Recruiting
Shanghai, Shanghai, China, 200123
Contact: Jin Li, MD    86-21-38804518    lijin@csco.org.cn   
Principal Investigator: Jin Li, MD         
Sponsors and Collaborators
Shanghai JMT-Bio Inc.
Investigators
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Principal Investigator: Jin Li, MD Shanghai East Hospital
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Responsible Party: Shanghai JMT-Bio Inc.
ClinicalTrials.gov Identifier: NCT04630522    
Other Study ID Numbers: JMT103CN01-1
First Posted: November 16, 2020    Key Record Dates
Last Update Posted: November 16, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Vitamin D
Calcium, Dietary
Calcium
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents