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

Primary Purpose

Bone Metastases From Solid Tumors

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

LY01011

Xgeva®

About this trial

This is an interventional treatment trial for Bone Metastases From Solid Tumors

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The First Affiliated Hospital of Guangdong Pharmaceutical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LY01011

Xgeva®+LY01011

Arm Description

Subcutaneous injection of LY01011 120 mg (1.7ml) every 4 weeks for a maximum of 13 consecutive doses up to week 49.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The time to first on-study skeletal-related event(SRE)

Incidence of SRE

Percent change in bone specific alkaline phosphatase (s-BALP) from baseline to weeks 13, 25, and 53.

Natural logarithm change in bone turnover marker-uNTx/uCr from baseline to weeks 25 and 53.

Full Information

NCT ID

NCT04859569

First Posted

April 22, 2021

Last Updated

June 2, 2021

Sponsor

Luye Pharma Group Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04859569

Brief Title

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

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Unknown status

Study Start Date

April 30, 2021 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Luye Pharma Group Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bone Metastases From Solid Tumors

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

850 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LY01011

Arm Type

Experimental

Arm Description

Subcutaneous injection of LY01011 120 mg (1.7ml) every 4 weeks for a maximum of 13 consecutive doses up to week 49.

Arm Title

Xgeva®+LY01011

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

LY01011

Other Intervention Name(s)

recombinant anti-RANKL human monoclonal antibody injection

Intervention Description

subcutaneously (SC) once every 4 weeks (Q4W)

Intervention Type

Drug

Intervention Name(s)

Xgeva®

Other Intervention Name(s)

Denosumab

Intervention Description

subcutaneously (SC) once every 4 weeks (Q4W)

Primary Outcome Measure Information:

Title

Natural logarithm change from baseline to week 13 in uNTx/uCr

Description

Time Frame

from baseline to week 13

Secondary Outcome Measure Information:

Title

The time to first on-study skeletal-related event(SRE)

Time Frame

from baseline to week 53

Title

Incidence of SRE

Time Frame

from baseline to week 53

Title

Percent change in bone specific alkaline phosphatase (s-BALP) from baseline to weeks 13, 25, and 53.

Time Frame

from baseline to weeks 13, 25, and 53

Title

Natural logarithm change in bone turnover marker-uNTx/uCr from baseline to weeks 25 and 53.

Time Frame

from baseline to weeks 25 and 53

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Phone

021-64175590

xchu2009@hotmail.com

Facility Information:

Facility Name

The First Affiliated Hospital of Guangdong Pharmaceutical University

City

Guangzhou

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xicheng Wang, master

Phone

13902400598

13902400598@126.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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