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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    850
  • sponsor
    Luye Pharma Group Ltd.
Updated on 16 June 2021

Summary

This is a multicenterrandomized, 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.

Details
Condition Bone Metastases From Solid Tumors
Treatment Xgeva®, LY01011
Clinical Study IdentifierNCT04859569
SponsorLuye Pharma Group Ltd.
Last Modified on16 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

The subject or his/her guardian and/or impartial witness voluntarily signed the written informed consent formICF
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 GroupECOGperformance status2
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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