Actively Recruiting
Phase I Study of sss40 Injection for Moderate-to-Severe Bone Metastatic Cancer Pain
Led by Shenyang Sunshine Pharmaceutical Co., LTD. · Updated on 2025-06-06
132
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase Ib/IIa, multicenter, sequential clinical trial evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of SSS40 injection in patients with moderate-to-severe bone metastatic cancer pain. The study includes two stages: a single-arm, open-label, dose-escalation and dose-expansion Phase Ib followed by a randomized, double-blind, placebo-controlled Phase IIa.
CONDITIONS
Official Title
Phase I Study of sss40 Injection for Moderate-to-Severe Bone Metastatic Cancer Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign informed consent and agree to follow study procedures
- Adult male or female aged 18 years or older
- Confirmed cancer diagnosis with bone metastasis verified by imaging within 120 days or by bone scan plus additional imaging
- Body weight of at least 40 kg at screening
- Expected survival time of 3 months or more
- Average pain score of 4 or greater at the bone metastasis site during screening and baseline
- Eastern Oncology Collaborative Group (ECOG) performance status score of 2 or less at screening
- Willingness to avoid prohibited drugs during the study
- Willingness to avoid chemotherapy drugs with significant bone marrow suppression from 14 days before to 28 days after dosing
- Bone marrow function meeting specified blood count thresholds at screening
- Renal function with estimated glomerular filtration rate of 30 mL/min or higher and urinary protein less than 2+
- Liver function within specified limits for bilirubin, AST, ALT, and alkaline phosphatase
- If not on anticoagulants, INR or prothrombin time less than 1.5 times upper limit of normal (ULN); if on anticoagulants, INR within recommended clinical range
- Female participants of childbearing potential agree to use reliable contraception for 6 months after starting medication and have no plans to conceive or donate eggs
- Male participants agree to use reliable contraception for 6 months after starting medication and have no plans for fathering children or sperm donation
- Ability to communicate effectively with researchers and comply with study requirements
You will not qualify if you...
- Hypercalcemia with blood calcium ≥ 2.75 mmol/L or 11.0 mg/dL at screening
- Pain caused by reasons unrelated to bone metastasis, such as intestinal obstruction, spinal cord compression, brain metastasis, or pathological fractures
- Neuropathic, visceral, or unknown nature pain mainly unrelated to bone metastasis
- Brain or meningeal metastases (except stable brain metastases)
- Systemic cancer treatments started within 14 days prior to baseline assessment, except stable treatments ongoing for at least 30 days
- Peripheral neuropathy or unstable neuropathy after radiation therapy within 30 days prior to baseline
- Unstable radiation therapy within 30 days prior to baseline or significant pain improvement after radiation
- Unstable doses of adjuvant analgesics started within 30 days prior to baseline
- Diagnosed knee or hip arthritis grade 2 or higher per American Rheumatology Association
- Major joint injuries or surgeries within the past year or history of osteonecrosis, osteoporotic fractures, or significant joint events
- Imaging evidence of rapidly progressive or atrophic osteoarthritis, subchondral fractures, spontaneous osteonecrosis, pathological fractures, neuroarthritis, crystalline arthritis, rheumatoid arthritis, lupus erythematosus, significant joint effusion or infection, or shoulder osteoarthritis
- Significant heart disease including severe heart failure, low ejection fraction, ischemic heart disease, or abnormal ECG findings
- Transient ischemic attack or stroke with lasting symptoms within 6 months
- Significant neurological diseases including dementia, recent head trauma, peripheral or autonomic neuropathy, epilepsy with recent seizures, or myopathy
- High score on Autonomous Neurological Symptom Survey
- History or symptoms of carpal tunnel syndrome within the past year
- History of allergic reactions to monoclonal antibodies or IgG fusion proteins
- Active infections such as hepatitis, HIV, or syphilis detected at screening
- Vaccination received within 1 month before screening
- History of alcohol or analgesic/anesthetic abuse within 6 months
- Previous exposure to exogenous nerve growth factor or anti-nerve growth factor antibodies
- Participation in other clinical trials within 30 days (90 days for investigational biologics)
- Severe acute or chronic diseases, mental disorders, or laboratory abnormalities increasing risk or affecting study results as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
Actively Recruiting
Research Team
R
Rui Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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