PK/PD Study of SHR-2017 Injection in 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

To evaluate the pharmacokinetic characteristics, pharmacodynamic characteristics, safety, tolerability and immunogenicity of SHR-2017 injection in patients with bone metastases, and to evaluate the efficacy of SHR-2017 injection in the treatment of skeletal-related event and cancer pain.

Study Overview

• Status: Completed
• Conditions: Patients With Bone Metastases
• Intervention / Treatment: Drug: SHR-2017

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Beijing Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-2017	Drug: SHR-2017; SHR-2017

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Pharmacokinetic parameters of SHR-2017 after administration, including Cmax	First dose up to 169 days post-dose
The Pharmacokinetic parameters of SHR-2017 after administration, including Tmax	First dose up to 169 days post-dose
The Pharmacokinetic parameters of SHR-2017 after administration, including AUC0-t	First dose up to 169 days post-dose
The Pharmacokinetic parameters of SHR-2017 after administration, including AUC0-∞	First dose up to 169 days post-dose
The Pharmacokinetic parameters of SHR-2017 after administration, including t1/2	First dose up to 169 days post-dose
The Pharmacokinetic parameters of SHR-2017 after administration, including CL/F	First dose up to 169 days post-dose
The pharmacodynamic parameter of SHR-2017 after administration include uNTX/uCr	First dose up to 169 days post-dose
The pharmacodynamic parameter of SHR-2017 after administration include β-CTX	First dose up to 169 days post-dose
The pharmacodynamic parameter of SHR-2017 after administration include BALP [Time	First dose up to 169 days post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in worst pain/average pain at the designated bone metastasis pain site after dosing	Worst pain / average pain was assessed on an 11-point numeric rating scale (NRS) ,The participant described the worst pain/average pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain)	First dose up to 169 days post-dose
Incidence of skeletal-related event		First dose up to 169 days post-dose
Average daily total opioids consumption		First dose up to 169 days post-dose]

Collaborators and Investigators

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2024
• Primary Completion (Actual): August 6, 2025
• Study Completion (Actual): August 6, 2025

Study Registration Dates

• First Submitted: April 18, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Site; Hematologic Diseases; Musculoskeletal Diseases; Neoplastic Processes; Bone Diseases; Neoplasm Metastasis; Bone Neoplasms; Bone Marrow Diseases
• Other Study ID Numbers: SHR-2017-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No