Evaluating SHR-2017 Injection for Patients with Bone Metastases

A Single-center, Open-label, Single-arm Phase Ib Clinical Study to Evaluate the Pharmacokinetics and Pharmacodynamic Characteristics of SHR-2017 Injection in Patients With Bone Metastases

This study is testing a new injection called SHR-2017 to see if it can help people with bone metastases manage their pain and improve their overall health.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06380881 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the pharmacokinetic and pharmacodynamic properties of SHR-2017 injection in patients suffering from bone metastases. It will evaluate the safety, tolerability, and immunogenicity of the treatment, as well as its efficacy in managing skeletal-related events and cancer pain. Participants will be closely monitored for their pain levels and overall health status throughout the study. The trial is designed for patients who have solid tumors with confirmed bone metastases and are experiencing significant pain despite stable analgesic treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with solid tumors and at least one documented bone metastasis experiencing moderate to severe pain.

Not a fit: Patients with bone metastases who are not experiencing significant pain or those with rapidly progressing disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve pain management and quality of life for patients with bone metastases.

How similar studies have performed: While there have been studies on similar treatments for bone metastases, the specific approach of SHR-2017 injection is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Male or female, age ≥ 18 years;
3. Solid tumors confirmed by histological or cytological examination;
4. At least 1 bone metastasis from a documented tertiary A hospital during the screening period;
5. Worst pain score NRS ≥5 points when treated with a stable analgesic regimen during the baseline assessment period;
6. Received a stable anti-tumor regimen within 28 days prior to the baseline assessment period
7. During the screening period, the physical status score of the Eastern Cooperative Oncology Group (ECOG) was 0-2 points;
8. Life expectancy judged by the investigator to be at least 6 months
9. Good organ function during the screening period (repeated testing can be confirmed if necessary);
10. Female subjects of childbearing potential with negative blood pregnancy test results within 7 days prior to the first dose of study drug and not lactating.

Exclusion Criteria:

1. Previous occurrence or concomitant osteomyelitis of the jaw or osteonecrosis of the jaw, dental disease or jaw disease that is active, requiring oral surgery, dental surgery or oral surgery wound that has not fully healed, or has planned invasive dental procedures during the study;
2. History of major joint trauma or surgery within 1 year prior to enrollment
3. Cardiac dysfunction Within 6 months before enrollment;
4. Resting tachycardia or resting bradycardia on ECG at screening；
5. Subjects who have evidence of orthostatic hypotension at screening；
6. Hepatitis B surface antigen (HBSAG), hepatitis C antibody (HCVAB), human immune defect antivirus (HIV) antibody, syphilis antibody;
7. The pain of the subjects not predominantly related to a bone metastasis;
8. The subject with neurological diseases and/or mental illness and/or cognitive dysfunction ；
9. Receipt of radiopharmaceutical treatment or radiotherapy for treatment of bone metastasis within 1 month of the treatment period, and the subject who received the radiotherapy within one month before the first research drug administration
10. Subject has a history of allergic or anaphylactic reaction to mammalian -based drugs, or allergies to supplements (calcium or vitamin D supplements), or have a history of allergens of opioids, or past history of treatment or diagnostic monoclonal antibody, Or other allergies;
11. The subject participated in the treatment of other clinical trials within one month before receiving the experimental drug (except for participating in other clinical trial screening losers);
12. In the judgment of the investigator, would make the subject inappropriate for entry into this study;

Where this trial is running

Beijing, Beijing

• Beijing Cancer Hospital — Beijing, Beijing, China (Recruiting)

Study contacts

• Study coordinator: Qin Liu

Conditions Patients With Bone Metastases