To Evaluate the Efficacy and Safety of QL1206 and Xgeva in Patients With Bone Metastases From Solid Tumors

NCT ID: NCT04550949

Last Updated: 2020-09-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-26
• Study Completion Date: 2022-06-10

Brief Summary

A multi-center, randomized, double-blind, comparative study to evaluate the clinical efficacy and safety of QL1206 and Xgeva® in patients with bone metastases from solid tumors.

Detailed Description

This is A multi-center, randomized, double-blind, comparative clinical trial.

The primary objective is to evaluate whether the clinical efficacy of QL1206 and Xgeva® are similar in patients with bone metastases from solid tumors.

The secondary objective are to evaluate whether the clinical safety and immunogenicity of QL1206 and Xgeva® are similar in patients with bone metastases from solid tumors.

Conditions

Bone Metastases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

QL1206

QL1206 injection(120mg)was administered subcutaneously once every 4 weeks for a maximum of 13 consecutive doses throughout the trial, according to the investigator's assessment.

Group Type: EXPERIMENTAL

QL1206

Intervention Type: DRUG

The active ingredient of QL1206 is a recombinant human anti-RANKL monoclonal antibody ,subcutaneous injection of 120 mg (1.7ml)every 4 weeks for a maximum of 13 consecutive doses throughout the trial.

Xgeva®

Xgeva® injection(120mg) was administered subcutaneously every 4 weeks for a maximum of 13 cumulative doses throughout the trial,according to the investigator's assessment.

Group Type: ACTIVE_COMPARATOR

Xgeva

Intervention Type: DRUG

The active ingredient of Xgeva® is denosumab,subcutaneous injection of 120 mg (1.7ml)every 4 weeks for a maximum of 13 consecutive doses throughout the trial.

Interventions

QL1206

The active ingredient of QL1206 is a recombinant human anti-RANKL monoclonal antibody ,subcutaneous injection of 120 mg (1.7ml)every 4 weeks for a maximum of 13 consecutive doses throughout the trial.

Intervention Type: DRUG

Xgeva

The active ingredient of Xgeva® is denosumab,subcutaneous injection of 120 mg (1.7ml)every 4 weeks for a maximum of 13 consecutive doses throughout the trial.

Intervention Type: DRUG

Other Intervention Names

recombinant human anti-RANKL monoclonal antibody injection; Denosumab Injection

Eligibility Criteria

Inclusion Criteria

1. Through the explanation of the researcher or the researcher's authorized representative, the subject has understood the nature and purpose of the study, as well as the research procedure, and the subject has signed the written informed consent;

2. Radiologic evidence (i.e. X-ray examination, computed tomography CT, magnetic resonance imaging MRI, positron emission computed tomography PET-CT) in grade III grade A hospitals has been documented (within 3 months prior to study administration) that there is at least one bone metastasis;

3. The ECOG score was 0-2.

4. Chinese adults with solid tumor confirmed by histological or cytological examination (age ≥18 years, ≤80 years).

Exclusion Criteria

1. Patients who had received any kind of intravenous or oral bisphosphonates before administration of the first study drug (those who had previously used an intravenous or oral bisphosphonates but had a continuous use time of less than 3 months and more than 5 years before the administration of this study could be included in the study).

2. Previous treatment with denosumab.

3. Previous or ongoing osteomyelitis or osteonecrosis of the jaw ONJ , active dental disease or jaw bone disease requiring oral surgery, the wound of dental operation or oral surgery has not healed well, or invasive dental operation has been planned during the study period.

4. Plan to perform radiotherapy or or bone surgery. Patients who received radiotherapy within one month before the first study drug administration were not allowed to be included.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Sun Yat-sen University Cancer Hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Facility Contacts

huiping LI, professor

Role: primary

huipingli2012@hotmail.com

010-88140650

li ZHANG, professor

Role: primary

zhangli@sysucc.org.cn

020-87342288

References

Liu Y, Zhang R, Wang X, Di L, Chen Z, Wang J, Sun T, Li Q, Cheng J, Zhang Q, Wang X, Wang J, Gu K, Wei S, Zhang S, Wang X, Sun P, Hao C, Zang A, Li Y, Han C, Kang X, Li Y, Li H. Comparison of efficacy and safety of a proposed biosimilar QL1206 with reference denosumab in patients with bone metastasis from breast cancer: A subgroup analysis of a randomized, double-blinded phase III study. Chin J Cancer Res. 2025 Jun 30;37(3):337-351. doi: 10.21147/j.issn.1000-9604.2025.03.04.

Reference Type: DERIVED

PMID: 40642487 (View on PubMed)

Li H, Huang Y, Chen Z, Zeng A, Zhang H, Yu Y, Wei S, Li Q, Wang X, Wang X, Wang X, Yang R, Dai X, Bi M, Sun T, Zhang Q, Han C, Li Y, Kang X, Liu Y, Zhang L. Efficacy and Safety of Denosumab Biosimilar QL1206 Versus Denosumab in Patients with Bone Metastases from Solid Tumors: A Randomized Phase III Trial. BioDrugs. 2023 Mar;37(2):259-269. doi: 10.1007/s40259-023-00579-5. Epub 2023 Feb 21.

Reference Type: DERIVED

PMID: 36802320 (View on PubMed)

Other Identifiers

QL1206-003

Identifier Type: -

Identifier Source: org_study_id