Clinical trial · Interventional
Efficacy and Safety of JMT103 in Patients With Giant Cell Tumor of Bone
A Phase Ib/II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of JMT103 in Surgically Unsalvageable or Refractory Giant Cell Tumor of Bone
NCT04255576CI-TRIAL-00061472unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Giant Cell Tumor of Bone | Giant Cell Tumor of Bone | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dietary Supplement: Calcium/Vitamin D | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental: JMT103
- description
- 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.
- interventionNames
- Dietary Supplement: Dietary Supplement: Calcium/Vitamin D
Primary outcomes (1)
- measure
- Percentage of Participants with Giant Cell Tumor Response
- timeFrame
- From enrollment until 12 weeks
- description
- 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.
Secondary outcomes (9)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Fully informed and signed informed consent. 2. Male or female, Adults, 18 years and older 3. Histologically confirmed GCTB that is surgically unsalvageable or for which the planned surgery is associated with severe morbidity. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. Exclusion Criteria: 1. Fertile subjects refuse to use effective contraception methods from the signing of the informed consent to 6 months after the last dose; 2. Active dental or jaw condition which requires oral surgery, including tooth extraction; 3. Currently receiving other anti-tumor therapy (radiotherapy, chemotherapy or arterial embolization, etc.); 4. Concurrent treatment with bisphosphonates; 5. Known history of second malignancy within the past 5 years, except for basal cell carcinoma or cervical carcinoma in situ.
References
Publications (2)
- DERIVEDXu 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
- DERIVEDXu 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