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Bone MetastasesPhase 3NCT04812509

Efficacy and Safety of MW032 and Xgeva® in Subjects With Bone Metastases From Solid Tumors

A Phase 3 study testing MW032 and Xgeva in people with Bone Metastases, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A multi-center, randomized, double-blind, parallel controlled Phase III clinical study to evaluate the clinical efficacy and safety of MW032 and Xgeva® in patients with bone metastases from solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bone Metastases
What is being tested?
MW032 and Xgeva
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
708 participants
Where
1 siteChina
Study dates
20 Mar 2020to 28 Jan 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathological confirmed malignant tumors (except hematological tumors);
  • Bone metastasis diagnosed by imaging (bone X-ray, CT scanning or magnetic resonance scanning) or pathology (bone biopsy) can be examined within 3 months before signing the informed consent,according to 《The expert consensus on clinical diagnosis and treatment of bone metastases and bone related diseases of malignant tumors (2014)》；
  • No limited of gender,age ≥ 18 years old;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2;
  • Estimated survival time was more than 6 months;
  • Subjects must have adequate organ function at baseline as defined below:① hematology: neutrophils ≥ 1,500/mcL, platelets ≥ 75,000/mcL, hemoglobin ≥ 80 g / L; ② renal function: creatinine (CR) clearance rate ≥ 30 ml / min; ③ Liver function: serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were less than or equal to 2.0 × upper normal limit (ULN) in subjects without liver metastasis; ALT and AST were less than or equal to 5.0 × ULN in subjects with liver metastasis; serum total bilirubin was less than or equal to 1.5 × ULN; ④ serum calcium (albumin correction) was more than or equal to 2.0 mmol / L (8.0 mg / dl) but less than or equal to 2.9 mmol / L (11.5 mg / dl). Note: calcium supplements should not be used at least 8 hours before serum calcium determination in screening period;
  • Subjects has understood the nature and purpose of the study, as well as the research procedure, and the subject has signed the written informed consent;

Who cannot join

  • Subjects with diseases not suitable for the study,in the Investigator's opinion (according to the subject's report or medical record review), such as:Other malignant tumors (different from the malignant solid tumors required in this study protocol) occurred within 3 years before enrollment, and in the active period;Other diseases affecting bone metabolism, such as vitamin D deficiency rickets, osteomalacia and primary osteoporosis, hyperparathyroidism, osteitis deformans, etc. (excluding osteoporosis);Human immunodeficiency virus or Treponema pallidum infection;Unstable liver disease, active period of hepatitis B virus or hepatitis C virus infection;Other serious or unstable physical or mental disorders.
  • Brain metastasis.
  • Oral and dental diseases: previous or current evidence of osteomyelitis or necrosis of the jaw; acute dental or mandibular diseases, need to be treated oral surgery; planned invasive dental surgery; failed dental or oral surgery.
  • Subjects with bone metastases need radiotherapy or surgery.
  • Previous treatment with denosumab.
  • Patients who had received any kind of intravenous or oral bisphosphonates before administration of the first study drug.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fifth Medical Center of PLA General Hospital

    Beijing, Beijing Municipality, 100011

Other trials in China

About this study

Official title: A Multi-center, Randomized, Double-blind, Parallel Controlled Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of Recombinant Human Anti RANKL Monoclonal Antibody Injection (MW032) and Denosumab (Xgeva®) in Subjects With Bone Metastases From Solid Tumors

A multi-center, randomized, double-blind, parallel controlled Phase III clinical study to evaluate the clinical efficacy and safety of MW032 and Xgeva® in patients with bone metastases from solid tumors.

Read the detailed description

This is A multi-center, randomized, double-blind, parallel controlled Phase III clinical trial.

The primary objective is to evaluate the clinical efficacy of MW032 and Xgeva® in patients with bone metastases from solid tumors.

The secondary objective are to evaluate the clinical safety and immunogenicity of MW032 and Xgeva® in patients with bone metastases from solid tumors.

Conditions
Bone Metastases
Being tested
MW032, Xgeva
Keywords
Denosumab, Biosimilarity, pharmacokinetics, pharmacodynamics, safety

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MW032Drug

    Also called recombinant human anti-RANKL monoclonal antibody injection

    The active ingredient of MW032 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 groups in NCT04812509
Study groupRoleWhat they receive
MW032ExperimentalMW032 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: MW032
Xgeva®Active comparatorXgeva® 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.

  1. uNTx/uCr

    Compare MW032 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)

  1. uNTx/uCr

    Compare the percentage change in MW032 and Xgeva® for bone conversion indicator uNTx/uCr among subjects with solid tumor metastasis (from baseline to weeks 5,25,37 and 53).

    Measured: from baseline to weeks 5,25,37 and 53

  2. S-BALP

    Compare the changes of bone specific alkaline phosphatase (S-BALP) from baseline to weeks 5,13, 25,37 and 53.

    Measured: from baseline to weeks 5,13,25,37 and 53

  3. SRE

    SRE occurrence

    Measured: from baseline to week 53

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2021
  2. Study start20 Mar 2020
  3. Primary completion29 Apr 2021
  4. Study completion28 Jan 2022

Resources

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
708 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04812509
Sponsor's protocol ID
MW032-2019-CP301
Status last verified
Feb 2023
First submitted
16 Mar 2021
Last updated
24 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Zhang S, Yin Y, Xiong H, Wang J, Liu H, Lu J, Zhang Q, Zhang L, Zhong J, Nie J, Lei K, Wang H, Yang S, Yao H, Wu H, Yu D, Ji X, Zhang H, Wu F, Xie W, Li W, Yao W, Zhong D, Sun H, Sun T, Guo Z, Wang R, Guo Y, Yu Z, Li D, Jin H, Song H, Chen X, Ma W, Hu Z, Liu D, Guo Y, Tang J, Jiang Z. Efficacy, Safety, and Population Pharmacokinetics of MW032 Compared With Denosumab for Solid Tumor-Related Bone Metastases: A Randomized, Double-Blind, Phase 3 Equivalence Trial. JAMA Oncol. 2024 Apr 1;10(4):448-455. doi: 10.1001/jamaoncol.2023.6520.

    PubMed 38329745

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MW032 and Xgeva in people with Bone Metastases, run by Mabwell (Shanghai) Bioscience Co., 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 24 Feb 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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 NCT04812509, which also lists 1 linked publication.

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 24 Feb 2023.

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