Clinical trial NCT04255576: Efficacy and Safety of JMT103 in Patients With Giant Cell Tumor of Bone
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Giant Cell Tumor of Bone
Lead sponsor: Shanghai JMT-Bio Inc.
Sponsor class: INDUSTRY
First posted: 2020-02-05
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants with Giant Cell Tumor Response
timeFrame: From enrollment until 12 weeks
Secondary outcomes:
measure: Proportion of Participants with Adverse Events (AEs)
timeFrame: From enrollment until 90 days after the last dose
measure: Objective Response Rate (ORR)
timeFrame: From enrollment until the last dose, no more than 24 months
measure: Changes in Brief Pain Inventory Short Form (BPI-SF)
timeFrame: From enrollment until the last dose, no more than 24 months
measure: Percentage of Patients with Surgical Resection of Tumor
timeFrame: From enrollment until the last dose, no more than 24 months
measure: Serum JMT103 Trough Concentrations
timeFrame: From enrollment until 90 days after the last dose
measure: Percent Change from Baseline in Serum C-terminus Peptide (of Type 1 Collagen) and Urinary N-telopeptide Corrected for Urine Creatinine
timeFrame: From enrollment until the last dose, no more than 24 months
measure: Number of Participants with Anti-JMT103 Antibodies
timeFrame: From enrollment until 90 days after the last dose
measure: Disease Control Rate (DCR)
timeFrame: From enrollment until the last dose, no more than 24 months
measure: Time to Progress (TTP)
timeFrame: From enrollment until the last dose, no more than 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ji Shui Tan Hospital
Study officials:
References: