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Trial Title:
PK/PD Study of SHR-2017 Injection in Patients With Bone Metastases
NCT ID:
NCT06380881
Condition:
Patients With Bone Metastases
Conditions: Official terms:
Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-2017
Description:
SHR-2017
Arm group label:
SHR-2017
Summary:
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.
Criteria for 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;
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Investigator:
Last name:
Huiping Li
Email:
Principal Investigator
Start date:
May 20, 2024
Completion date:
July 2025
Lead sponsor:
Agency:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Agency class:
Industry
Source:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06380881
