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

• ClinicalTrials.gov Identifier: NCT04550949
• Recruitment Status: Unknown
• First Posted: September 16, 2020
• Last Update Posted: September 22, 2020
• Sponsor: Qilu Pharmaceutical Co., Ltd.
• Information provided by (Responsible Party): Qilu Pharmaceutical Co., Ltd.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Bone Metastases	Drug: QL1206; Drug: Xgeva	Phase 3

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 700 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: April 26, 2019
• Estimated Primary Completion Date: March 1, 2021
• Estimated Study Completion Date: June 10, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: QL1206; 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; 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.; Other Name: recombinant human anti-RANKL monoclonal antibody injection
Active Comparator: Xgeva®; 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; 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.; Other Name: Denosumab Injection

Outcome Measures

Primary Outcome Measures :

1. 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)

Secondary Outcome Measures :

1. uNTx/uCr [ Time Frame: from baseline to weeks 25 and 53 ]
   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).
2. S-BALP [ Time Frame: from baseline to weeks 13, 25, and 53 ]
   Compare the changes of bone specific alkaline phosphatase (S-BALP) from baseline to weeks 13, 25, and 53.
3. SRE [ Time Frame: from baseline to weeks 53 ]
   SRE occurrence

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

China, Beijing

Beijing Cancer Hospital; Recruiting

Beijing, Beijing, China, 100037

Contact: huiping LI, professor 010-88140650 huipingli2012@hotmail.com

China, Guangdong

Sun Yat-sen University Cancer Hospital; Recruiting

Guangzhou, Guangdong, China, 510060

Contact: li ZHANG, professor 020-87342288 zhangli@sysucc.org.cn

Sponsors and Collaborators

Qilu Pharmaceutical Co., Ltd.

More Information

• Responsible Party: Qilu Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04550949
• Other Study ID Numbers: QL1206-003
• First Posted: September 16, 2020
• Last Update Posted: September 22, 2020
• Last Verified: September 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Neoplasm Metastasis; Bone Neoplasms; Bone Marrow Diseases; Neoplastic Processes; Neoplasms; Pathologic Processes; Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases; Hematologic Diseases; Denosumab; Bone Density Conservation Agents; Physiological Effects of Drugs