Bone Metastases From Solid TumorsPhase 3NCT04859569
Efficacy and Safety of LY01011 and Xgeva® in Patients With Bone Metastases From Solid Tumors
A Phase 3 study testing LY01011 and Xgeva® in people with Bone Metastases From Solid Tumors, run by Luye Pharma Group Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bone Metastases From Solid Tumors
- What is being tested?
- LY01011 and Xgeva®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2021to 30 Jun 2023
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou
Xicheng Wang, master, 13902400598, 13902400598@126.com
About this study
Official title: A Phase III Study Comparing Efficacy and Safety of LY01011 and Xgeva®(Denosumab) in Patients With Bone Metastases From Solid Tumors
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.
Read the detailed description
The primary objective is to evaluate the similarity of clinical efficacy between LY01011 and Xgeva® in patients with bone metastases from solid tumors.
The secondary objective is to evaluate the similarity of clinical safety and immunogenicity between LY01011 and Xgeva® in patients with bone metastases from solid tumors.
Each subject will participate in the study for 53 weeks. Treatments are administered on day 1 and Q4W thereafter through week 49. All patients are instructed to take 500 mg calcium and 400 IU vitamin D daily.
- Conditions
- Bone Metastases From Solid Tumors
- Being tested
- LY01011, Xgeva®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY01011Drug
Also called recombinant anti-RANKL human monoclonal antibody injection
subcutaneously (SC) once every 4 weeks (Q4W)
Xgeva®Drug
Also called Denosumab
subcutaneously (SC) once every 4 weeks (Q4W)
| Study group | Role | What they receive |
|---|---|---|
| LY01011 | Experimental | Subcutaneous injection of LY01011 120 mg (1.7ml) every 4 weeks for a maximum of 13 consecutive doses up to week 49. Receives: 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. Receives: Drug: LY01011; Drug: Xgeva® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from baseline to week 13
Secondary outcomes (4)
The time to first on-study skeletal-related event(SRE)
Measured: from baseline to week 53
Incidence of SRE
Measured: from baseline to week 53
Percent change in bone specific alkaline phosphatase (s-BALP) from baseline to weeks 13, 25, and 53.
Measured: from baseline to weeks 13, 25, and 53
Natural logarithm change in bone turnover marker-uNTx/uCr from baseline to weeks 25 and 53.
Measured: from baseline to weeks 25 and 53
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start30 Apr 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Metastases From Solid TumorsStudies of the same condition, open and under way.
- More trials run by Luye Pharma Group 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
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859569
- Sponsor's protocol ID
- LY01011/CT-CHN-303
- Status last verified
- Jun 2021
- First submitted
- 22 Apr 2021
- Last updated
- 7 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study Comparing Efficacy and Safety of LY01011 and Xgeva®(Denosumab) in Patients With Bone Metastases From Solid Tumors
- ClinicalTrials.gov ID
- NCT04859569
- Acronym / sponsor ID
- LY01011/CT-CHN-303
- Conditions
- Bone Metastases From Solid Tumors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 26 Apr 2021 (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.
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.
Detailed description
The primary objective is to evaluate the similarity of clinical efficacy between LY01011 and Xgeva® in patients with bone metastases from solid tumors.
The secondary objective is to evaluate the similarity of clinical safety and immunogenicity between LY01011 and Xgeva® in patients with bone metastases from solid tumors.
Each subject will participate in the study for 53 weeks. Treatments are administered on day 1 and Q4W thereafter through week 49. All patients are instructed to take 500 mg calcium and 400 IU vitamin D daily.
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 |
|---|---|---|
| LY01011 | Experimental | Drug: LY01011Subcutaneous injection of LY01011 120 mg (1.7ml) every 4 weeks for a maximum of 13 consecutive doses up to week 49. |
| Xgeva®+LY01011 | Active comparator | Drug: LY01011, Drug: Xgeva®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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| LY01011Also: recombinant anti-RANKL human monoclonal antibody injectionsubcutaneously (SC) once every 4 weeks (Q4W) | Drug | LY01011, Xgeva®+LY01011 |
| Xgeva®Also: Denosumabsubcutaneously (SC) once every 4 weeks (Q4W) | Drug | Xgeva®+LY01011 |
Primary outcome
Natural logarithm change from baseline to week 13 in uNTx/uCr
Time frame: from baseline to week 13
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.
4 secondary outcomes
The time to first on-study skeletal-related event(SRE)
Time frame: from baseline to week 53
Incidence of SRE
Time frame: from baseline to week 53
Percent change in bone specific alkaline phosphatase (s-BALP) from baseline to weeks 13, 25, and 53.
Time frame: from baseline to weeks 13, 25, and 53
Natural logarithm change in bone turnover marker-uNTx/uCr from baseline to weeks 25 and 53.
Time frame: from baseline to weeks 25 and 53
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LY01011 and Xgeva® in people with Bone Metastases From Solid Tumors, run by Luye Pharma Group Ltd. at 1 site 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 5 inclusion and 5 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 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Hu (021-64175590, xchu2009@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Natural logarithm change from baseline to week 13 in 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?
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 7 Jun 2021.