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

NCT ID: NCT05265052

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 177 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2025-12-31

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

3D1002 50 mg group (Phase IIa)

3D1002 is given 50 mg twice a day for 2 weeks.

Group Type: EXPERIMENTAL

3D1002 (50 mg)(Phase IIa)

Intervention Type: DRUG

1 tablet of 3D1002 per oral dose

3D1002 100 mg group (Phase IIa)

3D1002 is given 100 mg twice a day for 2 weeks.

Group Type: EXPERIMENTAL

3D1002 (100 mg)(Phase IIa)

Intervention Type: DRUG

2 tablets of 3D1002 per oral dose

3D1002 150 mg group (Phase IIa)

3D1002 is given 150 mg twice a day for 2 weeks.

Group Type: EXPERIMENTAL

3D1002 (150 mg)(Phase IIa)

Intervention Type: DRUG

3 tablets of 3D1002 per oral dose

3D1002 monotherapy group (Phase IIb)

3D1002 at recommended dose plus mimic OxyContin tables, will be given twice a day for 2 weeks.

Group Type: EXPERIMENTAL

3D1002 monotherapy (Phase IIb)

Intervention Type: DRUG

3D1002 is administered at recommended dose with mimic OxyContin tablets.

OxyContin monotherapy group (Phase IIb)

OxyContin initiating at 10mg per dose plus mimic 3D1002 tablets, will be given twice a day for 2 weeks.

Group Type: EXPERIMENTAL

OxyContin monotherapy (Phase IIb)

Intervention Type: DRUG

OxyContin is administered at an initial dose of 10 mg per dose with mimic 3D1002 tablets.

3D1002 + OxyContin group (Phase IIb)

3D1002 at recommended dose plus OxyContin initiating at 10 mg per dose, will be given twice a day for 2 weeks.

Group Type: EXPERIMENTAL

3D1002 + OxyContin (Phase IIb)

Intervention Type: DRUG

3D1002 is administered at recommended dose, and OxyContin is administered at an initial dose of 10 mg per dose.

Interventions

3D1002 (50 mg)(Phase IIa)

1 tablet of 3D1002 per oral dose

Intervention Type: DRUG

3D1002 (100 mg)(Phase IIa)

2 tablets of 3D1002 per oral dose

Intervention Type: DRUG

3D1002 (150 mg)(Phase IIa)

3 tablets of 3D1002 per oral dose

Intervention Type: DRUG

3D1002 monotherapy (Phase IIb)

3D1002 is administered at recommended dose with mimic OxyContin tablets.

Intervention Type: DRUG

OxyContin monotherapy (Phase IIb)

OxyContin is administered at an initial dose of 10 mg per dose with mimic 3D1002 tablets.

Intervention Type: DRUG

3D1002 + OxyContin (Phase IIb)

3D1002 is administered at recommended dose, and OxyContin is administered at an initial dose of 10 mg per dose.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Subject must sign the informed consent in person prior to beginning any screening procedure.

2. Age ≥18, both male and female.

3. Subjects with a malignant tumor confirmed by histopathology or cytology.

4. Weight ≥40 kg at screening period.

5. Subjects have relatively stable cancer pain and require continuous analgesic medications (estimated treatment duration ≥2 weeks), as assessed by the investigator.

6. Estimated life expectancy ≥3 months.

7. Subjects are willing to not use any analgesic other than those specified in the study during the study treatment period.

8. ECOG PS score is 0-3.

9. Have adequate organ and bone marrow function.

10. The mean NRS scores per day during the washout period are ≥4.

Exclusion Criteria

1. 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.

2. Have a persistent pain resulted from other medical conditions or unknown causes.

3. Subjects presenting with emergency symptoms such as intestinal obstruction/perforation, spinal cord compression, epidural metastasis, or fracture.

4. Subjects with known active/symptomatic central nervous system metastasis and/or cancerous meningitis.

5. Subjects plan to be treated with >10 mg/ day of prednisone or equivalent systemic corticosteroid during the study period.

6. Have a history of gastrointestinal bleeding or perforation.

7. Have a positive result of fecal occult blood test during screening period.

8. Have a history of serious cardiovascular diseases.

9. Have a history of an acute ischemic or hemorrhagic stroke within 6 months prior to screening.

10. Have a history of significant psychiatric disorders, such as schizophrenia and depression.

11. Subjects plan to receive radiotherapy, surgery, or a new regimen of systemic antitumor agents during the study treatment period (D1-D15).

12. Subjects have a history of alcohol abuse or drug abuse including opioids.

13. Subjects have significant opioid contraindications.

14. Pregnant or lactating women.

15. Subjects with other diseases that affect the oral administration or absorption of drugs.

16. Subjects are currently participating in another clinical study.

17. Other conditions deemed by the investigator to be inappropriate for participation in this study, such as poor compliance.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

3D Medicines

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suxia Luo

Role: PRINCIPAL_INVESTIGATOR

Henan Cancer Hospital

Central Contacts

Qiling Huang

Role: CONTACT

qiling.huang@3d-medicines.com

18312677976

Other Identifiers

3D1002-CN-001

Identifier Type: -

Identifier Source: org_study_id