Patients With Bone MetastasesPhase 1NCT06380881
PK/PD Study of SHR-2017 Injection in Patients With Bone Metastases
A Phase 1 study testing SHR-2017 in people with Patients With Bone Metastases, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Bone Metastases
- What is being tested?
- SHR-2017
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2024to 6 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide a written informed consent
- Male or female, age ≥ 18 years;
- Solid tumors confirmed by histological or cytological examination;
- At least 1 bone metastasis from a documented tertiary A hospital during the screening period;
- Worst pain score NRS ≥5 points when treated with a stable analgesic regimen during the baseline assessment period;
- Received a stable anti-tumor regimen within 28 days prior to the baseline assessment period
Show all 10Show fewer
- During the screening period, the physical status score of the Eastern Cooperative Oncology Group (ECOG) was 0-2 points;
- Life expectancy judged by the investigator to be at least 6 months
- Good organ function during the screening period (repeated testing can be confirmed if necessary);
- 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.
Who cannot join
- 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;
- History of major joint trauma or surgery within 1 year prior to enrollment
- Cardiac dysfunction Within 6 months before enrollment;
- Resting tachycardia or resting bradycardia on ECG at screening；
- Subjects who have evidence of orthostatic hypotension at screening；
- Hepatitis B surface antigen (HBSAG), hepatitis C antibody (HCVAB), human immune defect antivirus (HIV) antibody, syphilis antibody;
Show all 12Show fewer
- The pain of the subjects not predominantly related to a bone metastasis;
- The subject with neurological diseases and/or mental illness and/or cognitive dysfunction ；
- 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
- 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;
- 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);
- In the judgment of the investigator, would make the subject inappropriate for entry into this study;
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Patients With Bone Metastases
- Being tested
- SHR-2017
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-2017Drug
SHR-2017
| Study group | Role | What they receive |
|---|---|---|
| SHR-2017 | Experimental | Not described Receives: Drug: SHR-2017 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Pharmacokinetic parameters of SHR-2017 after administration, including Cmax
Measured: First dose up to 169 days post-dose
The Pharmacokinetic parameters of SHR-2017 after administration, including Tmax
Measured: First dose up to 169 days post-dose
The Pharmacokinetic parameters of SHR-2017 after administration, including AUC0-t
Measured: First dose up to 169 days post-dose
The Pharmacokinetic parameters of SHR-2017 after administration, including AUC0-∞
Measured: First dose up to 169 days post-dose
The Pharmacokinetic parameters of SHR-2017 after administration, including t1/2
Measured: First dose up to 169 days post-dose
The Pharmacokinetic parameters of SHR-2017 after administration, including CL/F
Measured: First dose up to 169 days post-dose
The pharmacodynamic parameter of SHR-2017 after administration include uNTX/uCr
Measured: First dose up to 169 days post-dose
The pharmacodynamic parameter of SHR-2017 after administration include β-CTX
Measured: First dose up to 169 days post-dose
The pharmacodynamic parameter of SHR-2017 after administration include BALP [Time
Measured: First dose up to 169 days post-dose
Secondary outcomes (3)
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)
Measured: First dose up to 169 days post-dose
Incidence of skeletal-related event
Measured: First dose up to 169 days post-dose
Average daily total opioids consumption
Measured: First dose up to 169 days post-dose]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start20 May 2024
- Primary completion6 Aug 2025
- Study completion6 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Bone MetastasesStudies of the same condition, open and under way.
- More trials run by Suzhou Suncadia Biopharmaceuticals Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380881
- Sponsor's protocol ID
- SHR-2017-102
- Status last verified
- Oct 2025
- First submitted
- 18 Apr 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06380881
- Acronym / sponsor ID
- SHR-2017-102
- Conditions
- Patients With Bone Metastases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 May 2024 (actual)
- Primary completion
- 6 Aug 2025 (actual)
- Study completion
- 6 Aug 2025 (actual)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-2017 | Experimental | Drug: SHR-2017 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Able and willing to provide a written informed consent
- Male or female, age ≥ 18 years;
- Solid tumors confirmed by histological or cytological examination;
- At least 1 bone metastasis from a documented tertiary A hospital during the screening period;
- Worst pain score NRS ≥5 points when treated with a stable analgesic regimen during the baseline assessment period;
Key exclusion criteria (12 listed)
- 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;
- History of major joint trauma or surgery within 1 year prior to enrollment
- Cardiac dysfunction Within 6 months before enrollment;
- Resting tachycardia or resting bradycardia on ECG at screening；
- Subjects who have evidence of orthostatic hypotension at screening；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-2017SHR-2017 | Drug | SHR-2017 |
Primary outcome
The Pharmacokinetic parameters of SHR-2017 after administration, including Cmax
Time frame: First dose up to 169 days post-dose
The Pharmacokinetic parameters of SHR-2017 after administration, including Tmax
Time frame: First dose up to 169 days post-dose
The Pharmacokinetic parameters of SHR-2017 after administration, including AUC0-t
Time frame: First dose up to 169 days post-dose
The Pharmacokinetic parameters of SHR-2017 after administration, including AUC0-∞
Time frame: First dose up to 169 days post-dose
The Pharmacokinetic parameters of SHR-2017 after administration, including t1/2
Time frame: First dose up to 169 days post-dose
The Pharmacokinetic parameters of SHR-2017 after administration, including CL/F
Time frame: First dose up to 169 days post-dose
The pharmacodynamic parameter of SHR-2017 after administration include uNTX/uCr
Time frame: First dose up to 169 days post-dose
The pharmacodynamic parameter of SHR-2017 after administration include β-CTX
Time frame: First dose up to 169 days post-dose
The pharmacodynamic parameter of SHR-2017 after administration include BALP [Time
Time frame: First dose up to 169 days post-dose
3 secondary outcomes
Change from baseline in worst pain/average pain at the designated bone metastasis pain site after dosing
Time frame: First dose up to 169 days post-dose
Incidence of skeletal-related event
Time frame: First dose up to 169 days post-dose
Average daily total opioids consumption
Time frame: First dose up to 169 days post-dose]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Patients With Bone Metastases
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Active, not recruitingPhase 3
Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy
Melanoma, Ovarian Cancer
RecruitingPhase 2
Iscador® P (Mistletoe) Immunotherapy for Recurrent Resectable Osteogenic Sarcoma
Osteogenic Sarcoma Recurrent
Active, not recruiting
Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer
Bone Metastases, HER2-positive Breast Cancer
Not yet recruitingPhase 1
Maintenance Treatment With Imetelstat in Patients With High-Risk Myeloid Neoplasms After Allo-SCT
High-risk Myeloid Malignancy, Allogenic Stem Cell Transplantation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR-2017 in people with Patients With Bone Metastases, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Pharmacokinetic parameters of SHR-2017 after administration, including Cmax (time frame: First dose up to 169 days post-dose). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.