Phase I Study of sss40 Injection for Moderate-to-Severe Bone Metastatic Cancer Pain

NCT07008703 | Recruiting Phase 1

• 1 other identifier: SYSS-SSS40-MBP-I-02
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cancer Pain

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) Events (NCI-CTCAE V5.0)

  All adverse events occurring during the entire study period will be assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE Version 5.0)

  Up to Day 85

Secondary Outcomes (1)

• Pain intensity maximum change from baseline (NRS)

  Week 12

Study Arms (1)

SSS40

EXPERIMENTAL

Drug: Injection of humanized nerve growth factor (NGF) antibody， Dosage Form: Injection， Dosage: 20-60 mg ， Frequency: Single dose， Duration: efficacy assessed over 12 weeks

Drug: Injection of humanized nerve growth factor (NGF) antibody

Interventions

Injection of humanized nerve growth factor (NGF) antibody DRUG

Subcutaneous injection, 20mg

Also known as: SSS40

SSS40

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects 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 protocol;
• When signing the informed consent form, adult male or female subjects 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 local medical standards, such as bone scans, magnetic resonance imaging (MRI), computed tomography (CT) scans, or positron emission computed tomography (PET-CT) Scanning, diagnosed as bone metastasis based on CT/MRI/PET-CT. If the above examination is not performed within 120 days, a bone scan confirmation is required. If imaging only involves bone scanning, additional CT, MRI, or PET is required to confirm bone metastasis；
• 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 subjects are willing not to use prohibited drugs throughout the entire study period；
• The subjects 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 suppression include paclitaxel (PTX), docetaxel (TXT), vinorelbine (NVB), tiniposide (VM-26), vindesin (VDS), etoposide (VP-16), carboplatin (CBP), mitoxantrone (MITX), nitrogen mustard (HN2), daunorubicin (DNR), and doxorubicin (ADM) \[THP, MTX, 6-MP, and IFO\]；
• During screening, the bone marrow function of the subjects 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 count ≥ 90000/mm3 or ≥ 90 × 109/L; c. Hemoglobin ≥ 70.0 g/L；
• 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 (ALT) ≤ 2.5 × ULN (≤ 5.0 if the tumor affects the liver) × ULN; c. Alkaline phosphatase ≤ 5 × ULN；
• 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 necessary). Subjects currently receiving anticoagulant therapy must have an INR within the recommended range applicable to their clinical status；
• 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 agree to use reliable contraceptive measures within 6 months of starting the study medication and have no plans for childbirth or sperm donation；
• The subjects are able to communicate well with the researchers and complete the study in accordance with the research regulations.

You may not qualify if:

• During screening, there was hypercalcemia (blood calcium concentration ≥ 2.75mmol/L or 11.0mg/dL)；
• The pain of the subjects 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 subjects is neuropathic pain, visceral pain, or unknown in nature, caused by previous anti-tumor treatment, infection, or other reasons mainly unrelated to bone metastasis；
• Subjects with brain or meningeal metastases (patients with stable brain metastases can be included in this study)；
• 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 therapy；
• 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 reuptake inhibitors (SNRIs), tricyclic antidepressants, antiepileptics, bisphosphonates, desukumab, corticosteroids or muscle relaxants, etc.) should be used；
• 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., subjects with osteoporosis and mild traumatic or non traumatic fractures) or a history of joint related events, such as meniscus or knee ligament injuries (with or without surgical repair) or joint infections；
• 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) subchondral incomplete fractures, d) spontaneous knee joint osteonecrosis (SPONK), e) osteonecrosis, f) pathological fractures, g) neuroarthritis (Charcot's joint), h) crystalline arthritis, i) rheumatoid arthritis, j) lupus erythematosus, k) Significant knee joint effusion or active infection, l) shoulder osteoarthritis and other diseases. Note: i. Patients with bone necrosis secondary to radiotherapy (i.e. radiation-induced osteonecrosis) and related to bone metastasis (i.e. involving the tumor bone interface) are allowed to participate in this study. Ii. Subjects with pathological vertebral fractures with vertebral body damage less than 50% and no spinal canal damage are allowed to participate in this study. Iii. Subjects with pathological fractures of non weight-bearing bone (such as humerus) that have been treated (such as fixation) and have healed, if the fracture does not involve the large joint, can participate in this study；
• 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 fraction\<35%, ischemic heart disease, surgical treatment for coronary artery disease, and significantly abnormal electrocardiograms (resting tachycardia (heart rate ≥ 120 beats/min) or resting bradycardia (heart rate ≤ 45 beats/min) within the first 6 months of screening；
• 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 within the past year; c. Peripheral neuropathy or autonomic neuropathy (including chemotherapy related peripheral neuropathy); d. Epilepsy or epilepsy related diseases, with a history of epileptic seizures within 2 years prior to screening; e. Myopathy；
• 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；

Sponsors & Collaborators

• Shenyang Sunshine Pharmaceutical Co., LTD.: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

MeSH Terms

Conditions

Cancer Pain

Interventions

Nerve Growth Factor; Antibodies

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nerve Growth Factors; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Nerve Tissue Proteins; Biological Factors; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins

Study Officials

• Shuxia Luo

  HenanCancerHospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rui Li

CONTACT

024-25386202; zhangrui9@3sbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: June 6, 2025
• Study Start: March 27, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)