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

NCT04550949 | Unknown Phase 3

• 1 other identifier: QL1206-003
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 2

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.

Conditions

Bone Metastases

Outcome Measures

Primary Outcomes (1)

• uNTx/uCr

  Compare QL1206 and Xgeva® for percentage change in bone conversion index (BTM) - urinary type I collagen cross-linked peptide (uNTx) adjusted for urinary creatinine (uCr) in Chinese subjects with solid tumor bone metastasis (uNTx/uCr from baseline to week 13)

  from baseline to week 13

Secondary Outcomes (3)

• uNTx/uCr

  from baseline to weeks 25 and 53

• S-BALP

  from baseline to weeks 13, 25, and 53

• SRE

  from baseline to weeks 53

Study Arms (2)

QL1206

EXPERIMENTAL

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.

Drug: QL1206

Xgeva®

ACTIVE COMPARATOR

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.

Drug: Xgeva

Interventions

QL1206 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.

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

QL1206

Xgeva 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.

Also known as: Denosumab Injection

Xgeva®

Eligibility Criteria

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

You may qualify if:

• 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;
• 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;
• The ECOG score was 0-2.
• Chinese adults with solid tumor confirmed by histological or cytological examination (age ≥18 years, ≤80 years).

You may not qualify if:

• 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).
• Previous treatment with denosumab.
• 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.
• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (2)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

Sun Yat-sen University Cancer Hospital

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 40642487 DERIVED

• 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.

  PMID: 36802320 DERIVED

MeSH Terms

Interventions

QL1206; Denosumab

Intervention Hierarchy (Ancestors)

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

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: September 1, 2020
• First Posted: September 16, 2020
• Study Start: April 26, 2019
• Primary Completion: March 1, 2021
• Study Completion: June 10, 2022
• Last Updated: September 22, 2020

Record last verified: 2020-09

Locations

CN (2)