Clinical trial NCT06380881: PK/PD Study of SHR-2017 Injection in Patients With Bone Metastases
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Patients With Bone Metastases
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-04-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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;

Primary outcomes:
measure: The Pharmacokinetic parameters of SHR-2017 after administration, including Cmax
timeFrame: First dose up to 169 days post-dose
measure: The Pharmacokinetic parameters of SHR-2017 after administration, including Tmax
timeFrame: First dose up to 169 days post-dose
measure: The Pharmacokinetic parameters of SHR-2017 after administration, including AUC0-t
timeFrame: First dose up to 169 days post-dose
measure: The Pharmacokinetic parameters of SHR-2017 after administration, including AUC0-∞
timeFrame: First dose up to 169 days post-dose
measure: The Pharmacokinetic parameters of SHR-2017 after administration, including t1/2
timeFrame: First dose up to 169 days post-dose
measure: The Pharmacokinetic parameters of SHR-2017 after administration, including CL/F
timeFrame: First dose up to 169 days post-dose
measure: The pharmacodynamic parameter of SHR-2017 after administration include uNTX/uCr
timeFrame: First dose up to 169 days post-dose
measure: The pharmacodynamic parameter of SHR-2017 after administration include β-CTX
timeFrame: First dose up to 169 days post-dose
measure: The pharmacodynamic parameter of SHR-2017 after administration include BALP [Time
timeFrame: First dose up to 169 days post-dose
Secondary outcomes:
measure: Change from baseline in worst pain/average pain at the designated bone metastasis pain site after dosing
timeFrame: First dose up to 169 days post-dose
measure: Incidence of skeletal-related event
timeFrame: First dose up to 169 days post-dose
measure: Average daily total opioids consumption
timeFrame: First dose up to 169 days post-dose]
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References: