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

NCT04859569 | Unknown Phase 3

• 1 other identifier: LY01011/CT-CHN-303
• Study Type: interventional
• Target: 850
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Metastases From Solid Tumors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  from baseline to week 53

• Incidence of SRE

  from baseline to week 53

• 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

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

  from baseline to weeks 25 and 53

Study Arms (2)

LY01011

EXPERIMENTAL

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

Drug: LY01011

Xgeva®+LY01011

ACTIVE COMPARATOR

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; Drug: Xgeva®

Interventions

LY01011 DRUG

subcutaneously (SC) once every 4 weeks (Q4W)

Also known as: recombinant anti-RANKL human monoclonal antibody injection

LY01011; Xgeva®+LY01011

Xgeva® DRUG

subcutaneously (SC) once every 4 weeks (Q4W)

Also known as: Denosumab

Xgeva®+LY01011

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Guangdong Pharmaceutical University

Guangzhou, China

RECRUITING

MeSH Terms

Interventions

Denosumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Hu

CONTACT

021-64175590; xchu2009@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 26, 2021
• Study Start: April 30, 2021
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: June 7, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)