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

Suzhou Suncadia Biopharmaceuticals

Status and phase: Enrolling; Phase 2

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

Treatments: Drug: Denosumab；SHR-2017 placebo; Drug: SHR-2017、Denosumab placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07028268

SHR-2017-201

Details and patient eligibility

About

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

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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210 participants in 3 patient groups

Treatment group A: SHR-2017、Denosumab placebo

Experimental group

Treatment:

Drug: SHR-2017、Denosumab placebo

Drug: SHR-2017、Denosumab placebo

Treatment group B: SHR-2017、Denosumab placebo

Experimental group

Treatment:

Drug: SHR-2017、Denosumab placebo

Drug: SHR-2017、Denosumab placebo

Treatment group C: Denosumab；SHR-2017 placebo

Active Comparator group

Treatment:

Drug: Denosumab；SHR-2017 placebo