Clinical trial · Interventional
To Evaluate the Efficacy and Safety of QL1206 and Xgeva in Patients With Bone Metastases From Solid Tumors
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
NCT04550949CI-TRIAL-00047272unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Metastases | — | UNRESOLVED | — |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- QL1206
- description
- 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.
- interventionNames
- Drug: QL1206
- type
- ACTIVE_COMPARATOR
- label
- Xgeva®
- description
- 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.
- interventionNames
- Drug: Xgeva
Primary outcomes (1)
- measure
- uNTx/uCr
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDLiu 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
- DERIVEDLi 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