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New treatment option for Cancer Pain
Official title Phase I Study of sss40 Injection for Moderate-to-Severe Bone Metastatic Cancer Pain
ClinicalTrials.gov ID: NCT07008703
What this study is testing
What is Injection of humanized nerve growth factor (NGF) antibody?
Injection of humanized nerve growth factor (NGF) antibody is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for cancer pain.
Also referred to as SSS40.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The people voluntarily sign an informed consent form, voluntarily participate in the trial, and are willing and able to receive medication...
- When signing the informed consent form, adult male or female people aged ≥ 18 years old；
- Previous medical records confirm that the subject has cancer and is diagnosed with bone metastasis; During screening or within 120 days prior to...
- Weight ≥ 40kg during screening；
- Expected survival time ≥ 3 months；
You likely can't join if
- During screening, there was hypercalcemia (blood calcium concentration ≥ 2.75mmol/L or 11.0mg/dL)；
- The pain of the people is caused by reasons unrelated to cancer bone metastasis (such as intestinal obstruction/perforation, spinal cord compression...
- The pain of the people is neuropathic pain, visceral pain, or unknown in nature, caused by previous anti-tumor treatment, infection, or other reasons...
- people with brain or meningeal metastases (patients with stable brain metastases can be included in this study)；
- Starting systemic treatment for primary malignant tumors or bone metastases within 14 days prior to the first day of the baseline assessment period...
- Individuals who have developed peripheral neuropathy and unstable neuropathy after receiving radiation therapy for bone metastases within 30 days...
See the full eligibility criteria
Who can join
- The people voluntarily sign an informed consent form, voluntarily participate in the trial, and are willing and able to receive medication, examination, visits, and other related operations according to the trial...
- When signing the informed consent form, adult male or female people aged ≥ 18 years old；
- Previous medical records confirm that the subject has cancer and is diagnosed with bone metastasis; During screening or within 120 days prior to screening visits, Confirming bone metastasis through imaging according to...
- Weight ≥ 40kg during screening；
- Expected survival time ≥ 3 months；
- Pain at the site of cancer bone metastasis, with an average pain score of ≥ 4 points at the designated pain point of bone metastasis (screening period and baseline evaluation period of 3 days)；
- When screening, the Eastern Oncology Collaborative Group (ECOG) physical condition score was ≤ 2 points；
- The people are willing not to use prohibited drugs throughout the entire study period；
- The people are willing to refrain from using chemotherapy drugs with significant bone marrow suppression from 14 days before administration to 28 days after administration. Among them, drugs with significant bone marrow...
- During screening, the bone marrow function of the people meets the following requirements (if necessary, can be repeated for confirmation): a. Absolute neutrophil count (ANC) ≥ 1500/mm3 or ≥ 1.5 × 109/L; b. Platelet...
- When screening, the renal function meets the following requirements (if necessary, repeat the examination to confirm): a Estimated glomerular filtration rate ≥ 30 mL/min, and b. Urinary protein\<2+；
- During screening, liver function meets the following requirements (if necessary, can be repeated for confirmation): a. Total serum bilirubin ≤ 1.5 × ULN; b. Aspartate aminotransferase (AST) and alanine aminotransferase...
- If the subject is not currently receiving anticoagulant therapy, the international standardized ratio (INR) or prothrombin time (PT) during screening should be less than 1.5 × ULN (can be double checked to confirm if...
- Female participants of childbearing age must agree to use reliable contraceptive measures within 6 months after the start of the study medication and have no plans to conceive or donate eggs; Male participants must...
- The people are able to communicate well with the researchers and complete the study in accordance with the research regulations.
What rules you out
- During screening, there was hypercalcemia (blood calcium concentration ≥ 2.75mmol/L or 11.0mg/dL)；
- The pain of the people is caused by reasons unrelated to cancer bone metastasis (such as intestinal obstruction/perforation, spinal cord compression, brain metastasis, pathological fractures or near fractures, etc.)；
- The pain of the people is neuropathic pain, visceral pain, or unknown in nature, caused by previous anti-tumor treatment, infection, or other reasons mainly unrelated to bone metastasis；
- people with brain or meningeal metastases (patients with stable brain metastases can be included in this study)；
- Starting systemic treatment for primary malignant tumors or bone metastases within 14 days prior to the first day of the baseline assessment period, including chemotherapy and hormone therapy (excluding those who have...
- Individuals who have developed peripheral neuropathy and unstable neuropathy after receiving radiation therapy for bone metastases within 30 days prior to the first day of the baseline evaluation period；
- Individuals who receive unstable radiation therapy within 30 days prior to the first day of the baseline evaluation period or experience a significant decrease in NRS score (by more than 3 points) after radiation...
- Starting within 30 days prior to the baseline evaluation period, unstable doses of adjuvant analgesic therapy (such as unstable doses combined with single agent acetaminophen (paracetamol), serotonin/norepinephrine...
- Diagnosed as knee or hip arthritis or Kellgren Lawrence grade ≥ 2 according to the American Rheumatology Association (ACR) and clinical and imaging standards；
- Screening for major injuries or surgeries in major joints (such as hip, knee, or shoulder) within the previous year; Individuals with a history of osteonecrosis or osteoporotic fractures (i.e., people with osteoporosis...
- Imaging atlas, determined by researchers, with imaging evidence indicating any of the following diseases during screening: a) rapidly progressive osteoarthritis, b) atrophic or malnourished osteoarthritis, c)...
- Individuals with a clinically significant history of heart disease, including those classified by the New York Heart Association as grade III or IV congestive heart failure, left ventricular insufficiency ejection...
- Diagnosed as transient ischemic attack or stroke with sequelae (such as aphasia, significant motor or sensory dysfunction) within the first 6 months of screening；
- A clinically significant history, diagnosis, or symptoms and signs of neurological diseases, including but not limited to: a Alzheimer's disease or other types of dementia; b. Head trauma with clinical significance...
- Individuals with an overall impact score greater than 7 on the Autonomous Neurological Symptom Survey (SAS) during screening；
- Individuals with a history of carpal tunnel syndrome (CTS) and experiencing symptoms or signs of CTS within the year prior to screening；
- Individuals with a history of allergic reactions or rapid allergic reactions to therapeutic or diagnostic monoclonal antibodies or IgG fusion proteins；
- Positive cases of active hepatitis, HIV infection, and Treponema pallidum infection were found during screening；
- Vaccination received one month before screening；
- Screening for individuals with a significant history of alcohol abuse, abuse of analgesics or anesthetics within the first 6 months (excluding medications currently under treatment)；
- Previous exposure to exogenous nerve growth factor or anti nerve growth factor antibodies；
- Participate in other clinical studies within 30 days prior to the baseline evaluation period (90 days for investigational biologics)；
- The presence of severe acute or chronic diseases, mental disorders, or laboratory test abnormalities may increase the risk of people participating in this study or receiving treatment with study drugs, or may affect the...
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.