Bone MetastasesPhase 3NCT04550949
To Evaluate the Efficacy and Safety of QL1206 and Xgeva in Patients With Bone Metastases From Solid Tumors
A Phase 3 study testing QL1206 and Xgeva in people with Bone Metastases, run by Qilu Pharmaceutical Co., Ltd. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bone Metastases
- What is being tested?
- QL1206 and Xgeva
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 2 sitesChina
- Study dates
- 26 Apr 2019to 10 Jun 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100037
huiping LI, professor, 010-88140650, huipingli2012@hotmail.com
- Recruiting
Sun Yat-sen University Cancer Hospital
Guangzhou, Guangdong, 510060
li ZHANG, professor, 020-87342288, zhangli@sysucc.org.cn
About this study
Official title: 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
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.
Read the 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
- Being tested
- QL1206, Xgeva
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1206Drug
Also called recombinant human anti-RANKL monoclonal antibody injection
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.
XgevaDrug
Also called Denosumab Injection
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Xgeva |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: from baseline to week 13
Secondary outcomes (3)
uNTx/uCr
Compare the percentage change in QL1206 and Xgeva® for bone conversion indicator uNTx/uCr among subjects with solid tumor metastasis (from baseline to weeks 25 and 53).
Measured: from baseline to weeks 25 and 53
S-BALP
Compare the changes of bone specific alkaline phosphatase (S-BALP) from baseline to weeks 13, 25, and 53.
Measured: from baseline to weeks 13, 25, and 53
SRE
SRE occurrence
Measured: from baseline to weeks 53
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start26 Apr 2019
- Primary completion1 Mar 2021 (estimated)
- Study completion10 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550949
- Sponsor's protocol ID
- QL1206-003
- Status last verified
- Sep 2020
- First submitted
- 1 Sep 2020
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40642487Li 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.
PubMed 36802320
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04550949
- Acronym / sponsor ID
- QL1206-003
- Conditions
- Bone Metastases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Apr 2019 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 10 Jun 2022 (estimated)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QL1206 | Experimental | Drug: QL1206QL1206 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. |
| Xgeva® | Active comparator | Drug: XgevaXgeva® injection(120mg) was administered subcutaneously every 4 weeks for a maximum of 13 cumulative doses throughout the trial,according to the investigator's assessment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QL1206Also: recombinant human anti-RANKL monoclonal antibody injectionThe 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. | Drug | QL1206 |
| XgevaAlso: Denosumab InjectionThe 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. | Drug | Xgeva® |
Primary outcome
uNTx/uCr
Time frame: from baseline to week 13
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)
3 secondary outcomes
uNTx/uCr
Time frame: from baseline to weeks 25 and 53
S-BALP
Time frame: from baseline to weeks 13, 25, and 53
SRE
Time frame: from baseline to weeks 53
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
- Derived from this study: PubMed 40642487Liu 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.
- Derived from this study: PubMed 36802320Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QL1206 and Xgeva in people with Bone Metastases, run by Qilu Pharmaceutical Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
uNTx/uCr (time frame: from baseline to week 13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04550949, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020.