A Phase III Study Comparing Efficacy and Safety of LY01011 and Xgeva®(Denosumab) in Patients With Bone Metastases From Solid Tumors
试验速览
- 阶段
- 3 期
- 入组人数
- 850
- 试验地点
- 1
- 主要终点
- Natural logarithm change from baseline to week 13 in uNTx/uCr
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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≤
- •Adequate organ function at baseline.
排除标准
- •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.
研究组 & 干预措施
LY01011
Subcutaneous injection of LY01011 120 mg (1.7ml) every 4 weeks for a maximum of 13 consecutive doses up to week 49.
干预措施: LY01011 (Drug)
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.
干预措施: LY01011 (Drug)
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.
干预措施: Xgeva® (Drug)
结局指标
主要结局
Natural logarithm change from baseline to week 13 in uNTx/uCr
时间窗: from baseline to week 13
Compare LY01011 and Xgeva® for natural logarithm change in bone turnover marker(BTM) -urinary type I collagen cross-linked N-telopeptides (uNTx) corrected for urine creatinine(uCr) in chinese subjects with bone metastases from solid tumors.
次要结局
- Natural logarithm change in bone turnover marker-uNTx/uCr from baseline to weeks 25 and 53.(from baseline to weeks 25 and 53)
- The time to first on-study skeletal-related event(SRE)(from baseline to week 53)
- Percent change in bone specific alkaline phosphatase (s-BALP) from baseline to weeks 13, 25, and 53.(from baseline to weeks 13, 25, and 53)
- Incidence of SRE(from baseline to week 53)