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

Bone Metastases From Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04630522
• Other study ID #: JMT103CN01-1
• Status: Completed
• Phase: Phase 1
• Start date: October 31, 2020
• Est. completion date: March 31, 2023

Study information

• Verified date: November 2023
• Source: Shanghai JMT-Bio Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 295
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (NF?B) 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.

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Metastases From Solid Tumors
• Bone Neoplasms
• Neoplasm Metastasis

Intervention

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.
• Drug: JMT103- 120 mg SC Q8W
JMT103 is administered subcutaneously at a dose of 120 mg on day 1 of each 8-week cycle.
• 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.

Locations

Country	Name	City	State
China	Shanghai East Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai JMT-Bio Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change of urinary N-terminal telopeptide of type 1 collagen/creatine (U-NTX/Cr) from baseline to week 13		From enrollment to week 13.
Secondary	Incidence and type of adverse events (AEs)		From enrollment to 90 days after the last dose
Secondary	Incidence of Skeletal-related event(SRE)	SRE is defined as pathological fracture, radiotherapy to bone, surgery to bone, or spinal cord compression.	From enrollment to 90 days after the last dose
Secondary	Change in Pain Score (Brief Pain Inventory-Short Form,BPI-SF)		From enrollment to 90 days after the last dose
Secondary	Trough plasma concentration (Ctrough)		From enrollment to 90 days after the last dose
Secondary	Percentage change in serum C-terminus peptide (of Type 1 Collagen) from baseline		From enrollment to 90 days after the last dose
Secondary	Percentage change in serum bone-specific alkaline phosphatase (bALP) from baseline		From enrollment to 90 days after the last dose
Secondary	Number of patients with anti-JMT103 antibodies		From enrollment to 90 days after the last dose