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

June 2, 2021 updated by: Luye Pharma Group Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

850

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Guangzhou, China
        • Recruiting
        • The First Affiliated Hospital of Guangdong Pharmaceutical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LY01011
Subcutaneous injection of LY01011 120 mg (1.7ml) every 4 weeks for a maximum of 13 consecutive doses up to week 49.
Drug: LY01011
subcutaneously (SC) once every 4 weeks (Q4W)
Other Names:
  • recombinant anti-RANKL human monoclonal antibody injection
Active Comparator: 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.
Drug: LY01011
subcutaneously (SC) once every 4 weeks (Q4W)
Other Names:
  • recombinant anti-RANKL human monoclonal antibody injection
Drug: Xgeva®
subcutaneously (SC) once every 4 weeks (Q4W)
Other Names:
  • Denosumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Natural logarithm change from baseline to week 13 in uNTx/uCr
Time Frame: 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.
from baseline to week 13

Secondary Outcome Measures

Outcome Measure
Time Frame
The time to first on-study skeletal-related event(SRE)
Time Frame: from baseline to week 53
from baseline to week 53
Incidence of SRE
Time Frame: from baseline to week 53
from baseline to week 53
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
from baseline to weeks 13, 25, and 53
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
from baseline to weeks 25 and 53

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luye Pharma Group Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

April 22, 2021

First Submitted That Met QC Criteria

April 22, 2021

First Posted (Actual)

April 26, 2021

Study Record Updates

Last Update Posted (Actual)

June 7, 2021

Last Update Submitted That Met QC Criteria

June 2, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LY01011/CT-CHN-303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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