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 pain.
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.
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.
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Treatment groupsSee each treatment group below.