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

NCT04630522 | Completed Phase 1

• 1 other identifier: JMT103CN01-1
• Study Type: interventional
• Target: 295
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Metastases From Solid Tumors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Incidence and type of adverse events (AEs)

  From enrollment to 90 days after the last dose

• Incidence of Skeletal-related event（SRE）

  From enrollment to 90 days after the last dose

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

  From enrollment to 90 days after the last dose

• Trough plasma concentration （Ctrough）

  From enrollment to 90 days after the last dose

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

  From enrollment to 90 days after the last dose

Study Arms (3)

JMT103- 120 mg SC Q4W

EXPERIMENTAL

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

Drug: Drug: JMT103- 120 mg SC Q4W; Dietary Supplement: Dietary Supplement: Calcium Dietary Supplement: Vitamin D

JMT103- 120 mg SC Q8W

EXPERIMENTAL

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

Drug: Drug: JMT103- 120 mg SC Q8W; Dietary Supplement: Dietary Supplement: Calcium Dietary Supplement: Vitamin D

JMT103- 180 mg SC Q8W

EXPERIMENTAL

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

Drug: Drug: JMT103- 180 mg SC Q8W; Dietary Supplement: Dietary Supplement: Calcium Dietary Supplement: Vitamin D

Interventions

Drug: JMT103- 120 mg SC Q4W DRUG

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

JMT103- 120 mg SC Q4W

Drug: JMT103- 120 mg SC Q8W DRUG

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

JMT103- 120 mg SC Q8W

Drug: JMT103- 180 mg SC Q8W DRUG

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

JMT103- 180 mg SC Q8W

Dietary Supplement: Calcium Dietary Supplement: Vitamin D DIETARY_SUPPLEMENT

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.

JMT103- 120 mg SC Q4W; JMT103- 120 mg SC Q8W; JMT103- 180 mg SC Q8W

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai JMT-Bio Inc.: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200123, China

Location

Study Officials

• Jin Li, MD

  Shanghai East Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 16, 2020
• Study Start: October 31, 2020
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: November 9, 2023

Record last verified: 2023-11

Locations

CN (1)