Efficacy and Safety of LY01011 and Xgeva® in Patients With Bone Metastases From Solid Tumors

Bone Metastases From Solid Tumors Clinical Trial

Official title:

A Phase III Study Comparing Efficacy and Safety of LY01011 and Xgeva®(Denosumab) in Patients With Bone Metastases From Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04859569
• Other study ID #: LY01011/CT-CHN-303
• Status: Recruiting
• Phase: Phase 3
• Start date: April 30, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: June 2021
• Source: Luye Pharma Group Ltd.
• Contact: Hu
• Phone: 021-64175590
• Email: xchu2009[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 850
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Metastases From Solid Tumors
• Bone Neoplasms
• Neoplasm Metastasis

Intervention

Drug:
• LY01011
subcutaneously (SC) once every 4 weeks (Q4W)
• Xgeva®
subcutaneously (SC) once every 4 weeks (Q4W)

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Guangdong Pharmaceutical University	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Luye Pharma Group Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Natural logarithm change from baseline to week 13 in uNTx/uCr	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.	from baseline to week 13
Secondary	The time to first on-study skeletal-related event(SRE)		from baseline to week 53
Secondary	Incidence of SRE		from baseline to week 53
Secondary	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
Secondary	Natural logarithm change in bone turnover marker-uNTx/uCr from baseline to weeks 25 and 53.		from baseline to weeks 25 and 53