Efficacy and Safety of JMT103 in Patients With Giant Cell Tumor of Bone

NCT04255576 | Unknown Phase 1

• 1 other identifier: JMT103CN03
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase Ib/II, multicenter, single-arm, open-label study to evaluate the efficacy and safety of JMT103 in patients with surgically unsalvageable or refractory giant cell tumor of bone (GCTB).

Conditions

Giant Cell Tumor of Bone

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with Giant Cell Tumor Response

  A treatment response was defined for participants with tissue samples obtained and measured by histopathology as: at least 90% elimination of giant cells relative to Baseline. A response was defined for participants who have only radiographs (histopathology not available) as lack of progression of the target lesion (PR or CR) at week 12 by radiographic measurements compared with Baseline.

  From enrollment until 12 weeks

Secondary Outcomes (9)

• Proportion of Participants with Adverse Events (AEs)

  From enrollment until 90 days after the last dose

• Objective Response Rate (ORR)

  From enrollment until the last dose, no more than 24 months

• Changes in Brief Pain Inventory Short Form (BPI-SF)

  From enrollment until the last dose, no more than 24 months

• Percentage of Patients with Surgical Resection of Tumor

  From enrollment until the last dose, no more than 24 months

• Serum JMT103 Trough Concentrations

  From enrollment until 90 days after the last dose

Study Arms (1)

Experimental: JMT103

EXPERIMENTAL

Eligible subjects will receive JMT103 at a dose of 2 mg/kg SC Q4W with a loading dose of 2 mg/kg SC on study days 8 and 15.

Dietary Supplement: Dietary Supplement: Calcium/Vitamin D

Interventions

Dietary Supplement: Calcium/Vitamin D DIETARY_SUPPLEMENT

All subjects should be adequately supplemented with calcium and vitamin D (at least 500 mg of calcium and 400 IU of vitamin D), except in the case of pre-existing hypercalcemia.

Experimental: JMT103

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, Adults, 18 years and older
• Histologically confirmed GCTB that is surgically unsalvageable or for which the planned surgery is associated with severe morbidity.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.

You may not qualify if:

• Fertile subjects refuse to use effective contraception methods from the signing of the informed consent to 6 months after the last dose;
• Active dental or jaw condition which requires oral surgery, including tooth extraction;
• Currently receiving other anti-tumor therapy (radiotherapy, chemotherapy or arterial embolization, etc.);
• Concurrent treatment with bisphosphonates;
• Known history of second malignancy within the past 5 years, except for basal cell carcinoma or cervical carcinoma in situ.

Sponsors & Collaborators

• Shanghai JMT-Bio Inc.: lead

Study Sites (1)

Beijing Ji Shui Tan Hospital

Beijing, 100035, China

Location

Related Publications (2)

• Xu H, Zhou Y, Wei F, Ding Y, Shan H, Yang Y, Liu W, Jin T, Luo Y, Tang F, Lu M, He X, Zhang W, Yang S, Zhang L, Wang J, Li H, Tu C, Niu X. JMT103 versus Non-Denosumab or Denosumab Treatment in Chinese Patients with Unresectable or Surgically Challenging Giant Cell Tumor of Bone: A Propensity Score-Matched Comparison. Cancer Med. 2025 Nov;14(22):e71340. doi: 10.1002/cam4.71340.

  PMID: 41292259 DERIVED

• Xu H, Zhou Y, Liang L, Shen J, Yan W, Wang J, Li J, Zhang X, Huang G, Bi W, Guo Z, Xiao Y, Lin J, Yao W, Tong Z, Zhou W, Zhang G, Ye Z, Wang D, Yang J, Fan Z, Liu C, Qu G, Zhang Q, Wei F, Liu W, Tu C, Li H, Yuan J, Niu X. Efficacy and safety of JMT103 in patients with unresectable or surgically-challenging giant cell tumor of bone: a multicenter, phase Ib/II study. Nat Commun. 2024 Nov 5;15(1):9541. doi: 10.1038/s41467-024-53686-4.

  PMID: 39500883 DERIVED

MeSH Terms

Conditions

Giant Cell Tumor of Bone

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Giant Cell Tumors; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Bone Tissue

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

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

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: February 5, 2020
• Study Start: October 10, 2019
• Primary Completion: September 1, 2023
• Study Completion: October 1, 2023
• Last Updated: October 14, 2022

Record last verified: 2022-10

Locations

CN (1)