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

Primary Purpose

Bone Metastases From Solid Tumors

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Bone Metastases From Solid Tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
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

Exclusion Criteria:

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.
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.

Sites / Locations

Shanghai East HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

JMT103- 120 mg SC Q4W

JMT103- 120 mg SC Q8W

JMT103- 180 mg SC Q8W

Arm Description

Eligible patients will receive JMT103 120 mg SC Q4W for up to 13 cycles.

Eligible patients will receive JMT103 120 mg SC Q8W for up to 7 cycles.

Eligible patients will receive JMT103 180 mg SC Q8W for up to 7 cycles.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence and type of adverse events (AEs)

Incidence of Skeletal-related event（SRE）

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

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

Trough plasma concentration （Ctrough）

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

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

Number of patients with anti-JMT103 antibodies

Full Information

NCT ID

NCT04630522

First Posted

November 2, 2020

Last Updated

November 9, 2020

Sponsor

Shanghai JMT-Bio Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04630522

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Unknown status

Study Start Date

October 31, 2020 (Actual)

Primary Completion Date

December 31, 2021 (Anticipated)

Study Completion Date

May 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai JMT-Bio Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bone Metastases From Solid Tumors

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

JMT103- 120 mg SC Q4W

Arm Type

Experimental

Arm Description

Eligible patients will receive JMT103 120 mg SC Q4W for up to 13 cycles.

Arm Title

JMT103- 120 mg SC Q8W

Arm Type

Experimental

Arm Description

Eligible patients will receive JMT103 120 mg SC Q8W for up to 7 cycles.

Arm Title

JMT103- 180 mg SC Q8W

Arm Type

Experimental

Arm Description

Eligible patients will receive JMT103 180 mg SC Q8W for up to 7 cycles.

Intervention Type

Drug

Intervention Name(s)

Drug: JMT103- 120 mg SC Q4W

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Drug: JMT103- 120 mg SC Q8W

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Drug: JMT103- 180 mg SC Q8W

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Dietary Supplement: Calcium Dietary Supplement: Vitamin D

Intervention Description

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 Measure Information:

Title

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 Measure Information:

Title

Incidence and type of adverse events (AEs)

Time Frame