3D1002 in Combination With Oxycodone Hydrochloride Sustained-release Tablets in Patients With Moderate to Severe Cancer Pain

Starting soon · Phase 2

Conditions studied: Cancer Pain

In brief

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.

Key facts

Study ID

NCT05265052

Run by

3D Medicines

People needed

177

Starts

2026-12-01

Expected to finish

2026-12-01

Last updated by the study team

2026-03-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Full record on ClinicalTrials.gov

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