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Cancer PainPhase 2NCT05265052

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

A Phase 2 study testing 3D1002 (50 mg)(Phase IIa), 3D1002 (100 mg)(Phase IIa) and 3D1002 (150 mg)(Phase IIa) in people with Cancer Pain, run by 3D Medicines.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer Pain
What is being tested?
3D1002 (50 mg)(Phase IIa), 3D1002 (100 mg)(Phase IIa) and 3D1002 (150 mg)(Phase IIa)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
177 participants
Where
No sites listed yet
Study dates
Dec 2026to Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Qiling Huang contact

18312677976

qiling.huang@3d-medicines.com

About this study

Official title: 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

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.

Read the 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
Being tested
3D1002 (50 mg)(Phase IIa), 3D1002 (100 mg)(Phase IIa), 3D1002 (150 mg)(Phase IIa), 3D1002 monotherapy (Phase IIb), OxyContin monotherapy (Phase IIb)
Keywords
Cancer pain
Medical subject headings
Cancer Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3D1002 (50 mg)(Phase IIa)Drug

    1 tablet of 3D1002 per oral dose

  • 3D1002 (100 mg)(Phase IIa)Drug

    2 tablets of 3D1002 per oral dose

  • 3D1002 (150 mg)(Phase IIa)Drug

    3 tablets of 3D1002 per oral dose

  • 3D1002 monotherapy (Phase IIb)Drug

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

  • OxyContin monotherapy (Phase IIb)Drug

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

  • 3D1002 + OxyContin (Phase IIb)Drug

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

Study groups in NCT05265052
Study groupRoleWhat they receive
3D1002 50 mg group (Phase IIa)Experimental3D1002 is given 50 mg twice a day for 2 weeks.
Receives: Drug: 3D1002 (50 mg)(Phase IIa)
3D1002 100 mg group (Phase IIa)Experimental3D1002 is given 100 mg twice a day for 2 weeks.
Receives: Drug: 3D1002 (100 mg)(Phase IIa)
3D1002 150 mg group (Phase IIa)Experimental3D1002 is given 150 mg twice a day for 2 weeks.
Receives: Drug: 3D1002 (150 mg)(Phase IIa)
3D1002 monotherapy group (Phase IIb)Experimental3D1002 at recommended dose plus mimic OxyContin tables, will be given twice a day for 2 weeks.
Receives: Drug: 3D1002 monotherapy (Phase IIb)
OxyContin monotherapy group (Phase IIb)ExperimentalOxyContin initiating at 10mg per dose plus mimic 3D1002 tablets, will be given twice a day for 2 weeks.
Receives: Drug: OxyContin monotherapy (Phase IIb)
3D1002 + OxyContin group (Phase IIb)Experimental3D1002 at recommended dose plus OxyContin initiating at 10 mg per dose, will be given twice a day for 2 weeks.
Receives: Drug: 3D1002 + OxyContin (Phase IIb)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    ①Average pain intensity is calculated daily for the past 24 hours using the NRS (0 = No pain, 10 = Worst pain imaginable). ②PID (pain intensity difference): Baseline pain intensity score (for the day prior to the day of randomization) minus pain intensity score at each given day.③SPID: the sum of the pain intensity difference generated daily from day 1 to the designated day.

    Measured: 1 to 14 days after receiving study treatment

Secondary outcomes (13)

  1. Proportion of subjects who achieve effective pain control

    Effective pain control: mean NRS score within 0-3 points and episode of breakthrough pain ≤ 2 times in 24 hours

    Measured: 1 to 14 days after receiving study treatment

  2. Time to achieve effective pain control

    Measured: 1 to 14 days after receiving study treatment

  3. Time-specific pain intensity difference（PID）

    Measured: 1 to 14 days after receiving study treatment

  4. Sum of pain intensity difference (SPID) in the NRS within 3,5 and 7 days post-treatment

    Measured: from day 1 to 3, 5 and 7 after receiving study treatment, respectively

  5. Time-specific subject self-rated pain relief based on Brief Pain Inventory Short Form (BPI-SF) Questionnaire Item 8

    The pain relief is assessed daily for the past 24 hours based on the percentage of relief from baseline, ranging from 0 (no relief) to 100% (complete relief).

    Measured: 1 to 14 days after receiving study treatment

  6. Sum of subject self-rated pain relief based on BPI-SF Questionnaire Item 8 within 3,5,7 and 14 days post-treatment

    Measured: from day 1 to 3, 5, 7 and 14 after receiving study treatment, respectively

  7. Proportion of subjects with pain response over 7 and 14 days after treatment

    Pain response: at least 30% and 50% decrease in pain intensity NRS score from baseline.

    Measured: 1 to 14 days after receiving study treatment

  8. Time to pain response

    Measured: 1 to 14 days after receiving study treatment

  9. The number of breakthrough pain episodes and rescue dose of immediate-release oxycodone over 7 and 14 days after treatment;

    Measured: 1 to 14 days after receiving study treatment

  10. Time-specific oxycodone dose, including immediate-release oxycodone capsules and sustained-release oxycodone tablets (the latter is only applicable for phaseⅡb)

    Measured: 1 to 14 days after receiving study treatment

  11. Total dose of oxycodone over 3, 7, and 14 days post-treatment

    Measured: 1 to 14 days after receiving study treatment

  12. Patient's global impression of change (PGI-C) over 7 and 14 days after treatment (for phase IIb only)

    PGI-C is a participant rated instrument to measure participant's change in overall status of general condition including pain on a 7-point scale, with 1 being "very much improved" and 7 being "very much worse".

    Measured: 1 to 14 days after receiving study treatment

  13. Frequency and severity of adverse events during treatment

    Measured: 1 to 14 days after receiving study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2022
  2. Study startDec 2026 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Both phase IIa and IIb are randomized, parallel controlled studies.
Masking
None (open label)
Enrolment
177 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05265052
Sponsor's protocol ID
3D1002-CN-001
Status last verified
Mar 2026
First submitted
24 Jan 2022
Last updated
11 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 3D1002 (50 mg)(Phase IIa), 3D1002 (100 mg)(Phase IIa) and 3D1002 (150 mg)(Phase IIa) in people with Cancer Pain, run by 3D Medicines.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Qiling Huang (18312677976, qiling.huang@3d-medicines.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sum of pain intensity difference in the Numeric Rating Scale (NRS) within 14 days after the first study drug treatment (SPID14) (time frame: 1 to 14 days after receiving study treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05265052.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.

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