Trials / Completed
CompletedNCT04630522
Efficacy and Safety of JMT103 in Patients With Bone Metastases From Solid Tumors
A Randomized, Open-Label, Dose-finding, Multi-centre, Phase Ib Study toEvaluate the Efficacy and Safety of JMT103 in Patients With Bone Metastases From Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 295 (actual)
- Sponsor
- Shanghai JMT-Bio Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The objective of this trial is to evaluate the efficacy and safety of JMT103 in patients with bone metastases from solid tumors. Eligible patients will be randomly assigned to receive JMT103 120mg subcutaneously (SC) every 4 weeks (Q4W), 120mg subcutaneously (SC) every 8 weeks (Q8W) and 180mg subcutaneously (SC) every 8 weeks (Q8W) in a 1:1:1 ratio. Patients will receive the treatment until the completion of 48 weeks of treatment, intolerable toxicity, loss to follow-up, withdrawal (patient's decision or investigator's decision), whichever comes first.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Drug: JMT103- 120 mg SC Q4W | JMT103 is administered subcutaneously at a dose of 120 mg on day 1 of each 4-week cycle. |
| DRUG | Drug: JMT103- 120 mg SC Q8W | JMT103 is administered subcutaneously at a dose of 120 mg on day 1 of each 8-week cycle. |
| DRUG | Drug: JMT103- 180 mg SC Q8W | JMT103 is administered subcutaneously at a dose of 180 mg on day 1 of each 8-week cycle. |
| DIETARY_SUPPLEMENT | Dietary Supplement: Calcium Dietary Supplement: Vitamin D | 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. |
Timeline
- Start date
- 2020-10-31
- Primary completion
- 2023-03-31
- Completion
- 2023-03-31
- First posted
- 2020-11-16
- Last updated
- 2023-11-09
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04630522. Inclusion in this directory is not an endorsement.