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).
The objective of the trial is to evaluate the efficacy and safety of JMT103 in patients with GCTB that is surgically unsalvageable or for which the planned surgery is associated with severe morbidity. This study consists of two parts (phase Ib and II). In the phase Ib part, 6 to 12 subjects will be enrolled, and the safety, pharmacokinetics and pharmacodynamics of JMT103 will be evaluated after treatment for more than 4 weeks. And then the phase II part will be conducted, in which, 125 subjects will be enrolled. Eligible subjects will receive JMT103 at a dose of 2mg/kg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 2mg/kg SC on study days 8 and 15 until disease progression, tumor resection (the pathologic outcome after surgical resection is CR or PR), intolerable toxicity, decision by the participant to discontinue, or decision by the investigator that the subject could no longer benefit from the treatment (whichever occurs first).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
139
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.
Beijing Ji Shui Tan Hospital
Beijing, China
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.
Time frame: From enrollment until 12 weeks
Proportion of Participants with Adverse Events (AEs)
Time frame: From enrollment until 90 days after the last dose
Objective Response Rate (ORR)
Time frame: From enrollment until the last dose, no more than 24 months
Changes in Brief Pain Inventory Short Form (BPI-SF)
Assess pain and its effects on patients' mood, sleep, ability to move, appetite, daily life, ability to walk, and social interaction
Time frame: From enrollment until the last dose, no more than 24 months
Percentage of Patients with Surgical Resection of Tumor
Time frame: From enrollment until the last dose, no more than 24 months
Serum JMT103 Trough Concentrations
Time frame: From enrollment until 90 days after the last dose
Percent Change from Baseline in Serum C-terminus Peptide (of Type 1 Collagen) and Urinary N-telopeptide Corrected for Urine Creatinine
Time frame: From enrollment until the last dose, no more than 24 months
Number of Participants with Anti-JMT103 Antibodies
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Time frame: From enrollment until 90 days after the last dose
Disease Control Rate (DCR)
Time frame: From enrollment until the last dose, no more than 24 months
Time to Progress (TTP)
Time frame: From enrollment until the last dose, no more than 24 months