Efficacy and Safety of LY01011 and Xgeva® in Patients With Bone Metastases From Solid Tumors
NCT ID: NCT04859569
Last Updated: 2021-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
850 participants
INTERVENTIONAL
2021-04-30
2023-06-30
Brief Summary
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Detailed Description
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The secondary objective is to evaluate the similarity of clinical safety and immunogenicity between LY01011 and Xgeva® in patients with bone metastases from solid tumors.
Each subject will participate in the study for 53 weeks. Treatments are administered on day 1 and Q4W thereafter through week 49. All patients are instructed to take 500 mg calcium and 400 IU vitamin D daily.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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LY01011
Subcutaneous injection of LY01011 120 mg (1.7ml) every 4 weeks for a maximum of 13 consecutive doses up to week 49.
LY01011
subcutaneously (SC) once every 4 weeks (Q4W)
Xgeva®+LY01011
After subcutaneous injection of Xgeva® 120 mg (1.7ml) every 4 weeks 3 times, patients of Xgeva® group continue to receive LY01011 120 mg (1.7ml) every 4 weeks for ten doses consecutively.
LY01011
subcutaneously (SC) once every 4 weeks (Q4W)
Xgeva®
subcutaneously (SC) once every 4 weeks (Q4W)
Interventions
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LY01011
subcutaneously (SC) once every 4 weeks (Q4W)
Xgeva®
subcutaneously (SC) once every 4 weeks (Q4W)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged 18 to 80 Years old (Female or male subjects to the date of signing the informed consent form).
* Subjects with solid tumor confirmed by histological or cytological examination. At least one documented bone metastasis confirmed by computed tomography\[CT\], magnetic resonance imaging\[MRI\]) or pathology (bone biopsy).
* Eastern Cooperative Oncology Group（ECOG）performance status≤2.
* Adequate organ function at baseline.
Exclusion Criteria
* Subjects who previously received any bone-modifying agents (including intravenous or oral bisphosphonates, etc.) for advanced tumor disease.
* Orthopedic surgery or bone-related radiation therapy within 1 month prior to first dose. Bone radioisotope therapy within 6 months prior to first dose, or planned radiation therapy or surgery for bone during the study.
* Past or ongoing osteomyelitis or osteonecrosis of the jaws （ONJ）, an active dental or jaw condition requiring oral surgery, non-healed dental or oral surgery, or any planned invasive dental procedure during the study period.
* Primary central nervous system malignancy. Subjects with central nervous system metastases who have failed local therapy. Subjects with asymptomatic brain metastases or clinically stable brain metastases who do not require steroids and other therapy for brain metastases for ≥ 28 days may be enrolled.
18 Years
80 Years
ALL
No
Sponsors
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Luye Pharma Group Ltd.
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LY01011/CT-CHN-303
Identifier Type: -
Identifier Source: org_study_id
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