Status:
NOT_YET_RECRUITING
3D1002 in Combination With Oxycodone Hydrochloride Sustained-release Tablets in Patients With Moderate to Severe Cancer Pain
Lead Sponsor:
3D Medicines
Conditions:
Cancer Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study aims to evaluate the safety and efficacy of 3D1002 alone or in combination with oxycodone hydrochloride sustained-release tablets (OxyContin) for the management of moderate or severe cancer...
Detailed Description
The investigational product in this study, 3D1002, is a selective antagonist of prostaglandin E2 receptor subtype 4 (EP4). The study is composed of two stages. Phase IIa stage is to assess the safety ...
Eligibility Criteria
Inclusion
- Subject must sign the informed consent in person prior to beginning any screening procedure.
- Age ≥18, both male and female.
- Subjects with a malignant tumor confirmed by histopathology or cytology.
- Weight ≥40 kg at screening period.
- Subjects have relatively stable cancer pain and require continuous analgesic medications (estimated treatment duration ≥2 weeks), as assessed by the investigator.
- Estimated life expectancy ≥3 months.
- Subjects are willing to not use any analgesic other than those specified in the study during the study treatment period.
- ECOG PS score is 0-3.
- Have adequate organ and bone marrow function.
- The mean NRS scores per day during the washout period are ≥4.
Exclusion
- Known allergy to any of the active ingredients or excipients of the study drug, or have a history of allergy to other opioids or non-steroidal anti-inflammatory drugs (NSAIDs) and their related ingredients.
- Have a persistent pain resulted from other medical conditions or unknown causes.
- Subjects presenting with emergency symptoms such as intestinal obstruction/perforation, spinal cord compression, epidural metastasis, or fracture.
- Subjects with known active/symptomatic central nervous system metastasis and/or cancerous meningitis.
- Subjects plan to be treated with \>10 mg/ day of prednisone or equivalent systemic corticosteroid during the study period.
- Have a history of gastrointestinal bleeding or perforation.
- Have a positive result of fecal occult blood test during screening period.
- Have a history of serious cardiovascular diseases.
- Have a history of an acute ischemic or hemorrhagic stroke within 6 months prior to screening.
- Have a history of significant psychiatric disorders, such as schizophrenia and depression.
- Subjects plan to receive radiotherapy, surgery, or a new regimen of systemic antitumor agents during the study treatment period (D1-D15).
- Subjects have a history of alcohol abuse or drug abuse including opioids.
- Subjects have significant opioid contraindications.
- Pregnant or lactating women.
- Subjects with other diseases that affect the oral administration or absorption of drugs.
- Subjects are currently participating in another clinical study.
- Other conditions deemed by the investigator to be inappropriate for participation in this study, such as poor compliance.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT05265052
Start Date
December 1 2025
End Date
December 1 2025
Last Update
May 29 2025
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