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

Phase 3

• Conditions: Bone Metastases
• Interventions: Drug: Xgeva; Drug: QL1206

• Registration Number: NCT04550949
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

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.

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 Timeline

• Study Start: 2019-04-26
• Status Verified: 2020-09
• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-09
• Study First Posted: 2020-09-16
• Last Update Submitted: 2020-09-19
• Last Update Posted: 2020-09-22
• Primary Completion: 2021-03-01
• Study Completion: 2022-06-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 700

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xgeva®	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.
QL1206	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.

Primary Outcome Measures

Name	Time	Method
uNTx/uCr	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

Name	Time	Method
SRE	from baseline to weeks 53	SRE occurrence
uNTx/uCr	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).
S-BALP	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.

Trial Locations

Locations (2)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Sun Yat-sen University Cancer Hospital; 🇨🇳 Guangzhou, Guangdong, China