Not Yet RecruitingPhase 2

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

177 participantsStarted 2026-12

Plain-language 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 pain.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Sum of pain intensity difference in the Numeric Rating Scale (NRS) within 14 days after the first study drug treatment (SPID14)

Timeframe: 1 to 14 days after receiving study treatment

Trial details

NCT IDNCT05265052

Sponsor3D Medicines

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Qiling Huang

18312677976 qiling.huang@3d-medicines.com

View on ClinicalTrials.gov More Cancer Pain trials