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A Trial of SHR-2017 Injection in Patients With Bone Metastases From Solid Tumors

NCT ID: NCT07028268

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-24

Study Completion Date

2027-05-31

Brief Summary

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The study is being conducted to evaluate the efficacy, and safety of SHR-2017 Injection in Patients with Bone Metastases from Solid Tumors. To explore the reasonable dosage of SHR-2017 Injection for Bone Metastases from Solid Tumors

Detailed Description

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Conditions

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For Prevention of Bone Events in Patients With Bone Metastases From Solid Tumors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment group A: SHR-2017、Denosumab placebo

Group Type EXPERIMENTAL

SHR-2017、Denosumab placebo

Intervention Type DRUG

SHR-2017; high dose ；Denosumab placebo

Treatment group B: SHR-2017、Denosumab placebo

Group Type EXPERIMENTAL

SHR-2017、Denosumab placebo

Intervention Type DRUG

SHR-2017; low dose ；Denosumab placebo

Treatment group C: Denosumab；SHR-2017 placebo

Group Type ACTIVE_COMPARATOR

Denosumab；SHR-2017 placebo

Intervention Type DRUG

Denosumab；SHR-2017 placebo

Interventions

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SHR-2017、Denosumab placebo

SHR-2017; high dose ；Denosumab placebo

Intervention Type DRUG

SHR-2017、Denosumab placebo

SHR-2017; low dose ；Denosumab placebo

Intervention Type DRUG

Denosumab；SHR-2017 placebo

Denosumab；SHR-2017 placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Able and willing to provide a written informed consent；
2. Male or female, ≥18 years of age；
3. Histologically or cytologically confirmed solid tumors；
4. At least 1 bone metastasis demonstrated by radiologic imaging or histopathology；
5. Eastern Cooperative Oncology Group performance Status≤2。
6. Life expectancy was judged by the investigators to be at least 6 months;
7. Adequate organ function at Screening
8. Female subjects with a negative blood pregnancy test and are not breastfeeding

Exclusion Criteria

1. Pre-existing or comorbid related oral diseases or oral cavity requiring surgery, etc；
2. History of major joint (e.g., hip, knee, or shoulder) trauma or surgery prior to the first dose of the drug；
3. Received radiotherapeutic drugs or bone radiotherapy prior to the first study drug administration
4. Any cardiovascular disease for which the investigator considers the subject unfit to participate in the study
5. resting tachycardia or resting bradycardia;
6. The subject's pain is predominantly from pain unrelated to the bone metastases;
7. Subject is unable to perform a pain assessment;
8. Symptomatic or treatment-requiring brain metastases or other central nervous system metastases
9. Comorbid infectious disease
10. Prior receipt of exogenous nerve growth factor or anti-nerve growth factor antibodies;
11. Prior history of allergy to relevant drug ingredients or components;
12. Participation in other clinical trials within a certain period of time
13. Subjects who, in the opinion of the investigator, have any other factors
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suzhou Suncadia Biopharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qian Zhao

Role: CONTACT

Phone: +0518-82342973

Email: [email protected]

Other Identifiers

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SHR-2017-201

Identifier Type: -

Identifier Source: org_study_id