NCT05265052

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

A Multicenter, Randomized, Phase IIa/IIb Clinical Trial of 3D1002 Combined With Oxycodone Hydrochloride Sustained-release Tablets in the Treatment of Patients With Moderate to Severe Cancer Pain

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 177 (estimated)
• Sponsor: 3D Medicines · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 and efficacy of 3D1002 administered at doses of 50, 100 or 150 mg every 12 hour (q12h) for patients with moderate to severe cancer pain, and to determine the optimal recommended dose for further studies. Phase IIb stage is to evaluate the difference in the efficacy and safety of 3D1002 combined with OxyContin and OxyContin alone in treatment of patients with moderate to severe cancer pain.

Conditions

• Cancer Pain

Interventions

Type	Name	Description
DRUG	3D1002 (50 mg)(Phase IIa)	1 tablet of 3D1002 per oral dose
DRUG	3D1002 (100 mg)(Phase IIa)	2 tablets of 3D1002 per oral dose
DRUG	3D1002 (150 mg)(Phase IIa)	3 tablets of 3D1002 per oral dose
DRUG	3D1002 monotherapy (Phase IIb)	3D1002 is administered at recommended dose with mimic OxyContin tablets.
DRUG	OxyContin monotherapy (Phase IIb)	OxyContin is administered at an initial dose of 10 mg per dose with mimic 3D1002 tablets.
DRUG	3D1002 + OxyContin (Phase IIb)	3D1002 is administered at recommended dose, and OxyContin is administered at an initial dose of 10 mg per dose.

Timeline

• Start date: 2026-12-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2022-03-03
• Last updated: 2026-03-11