Clinical trial NCT04859569: Efficacy and Safety of LY01011 and Xgeva® in Patients With Bone Metastases From Solid Tumors
Official title: A Phase III Study Comparing Efficacy and Safety of LY01011 and Xgeva®(Denosumab) in Patients With Bone Metastases From Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Bone Metastases From Solid Tumors
Lead sponsor: Luye Pharma Group Ltd.
Sponsor class: INDUSTRY
First posted: 2021-04-26
Enrollment: 850
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter，randomized, double-blind, active-controlled, parallel-group study comparing efficacy and safety of LY01011 (recombinant anti-RANKL human monoclonal antibody injection) and Xgeva® in patients with bone metastases from solid tumors.

Detailed description: The primary objective is to evaluate the similarity of clinical efficacy between LY01011 and Xgeva® in patients with bone metastases from solid tumors.

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.

Eligibility criteria: Inclusion Criteria:

* The subject or his/her guardian and/or impartial witness voluntarily signed the written informed consent form（ICF）.
* 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:

* Prior treatment with denosumab or other RANKL-targeted therapeutic drugs.
* 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.

Primary outcomes:
measure: Natural logarithm change from baseline to week 13 in uNTx/uCr
timeFrame: from baseline to week 13
Secondary outcomes:
measure: The time to first on-study skeletal-related event(SRE)
timeFrame: from baseline to week 53
measure: Incidence of SRE
timeFrame: from baseline to week 53
measure: Percent change in bone specific alkaline phosphatase (s-BALP) from baseline to weeks 13, 25, and 53.
timeFrame: from baseline to weeks 13, 25, and 53
measure: Natural logarithm change in bone turnover marker-uNTx/uCr from baseline to weeks 25 and 53.
timeFrame: from baseline to weeks 25 and 53
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangdong Pharmaceutical University
Study officials:
References: