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

NCT04859569 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 850

Last updated 2021-06-07

No results posted yet for this study

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.

Conditions

  • Bone Metastases From Solid Tumors

Interventions

DRUG

LY01011

subcutaneously (SC) once every 4 weeks (Q4W)

DRUG

Xgeva®

subcutaneously (SC) once every 4 weeks (Q4W)

Sponsors & Collaborators

  • Luye Pharma Group Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-30
Primary Completion
2022-12-31
Completion
2023-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04859569 on ClinicalTrials.gov