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NCT Number: NCT07832747

A Study of DCC-3014 to Evaluate the Efficacy, Safety, and Pharmacokinetics in Subjects With TGCT

To evaluate the efficacy, safety, and pharmacokinetics of DCC-3014 in subjects with Tenosynovial Giant Cell Tumor

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Key information

Conditions

Tenosynovial Giant Cell Tumor Giant Cell Tumor of Tendon Sheath Giant Cell Tumors Joint Diseases Muscular Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Synovitis Tendinopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cancer Institute Hospital of JFCR

Tokyo, Koto, 135-8550, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed diagnosis of TGCT (tumor biopsy to confirm diagnosis will be required if no histology/pathology is available at screening), and a TGCT in a single joint that can be assessed for range of motion (ROM)
  • TGCT for which surgical resection will potentially cause worsening functional limitation or severe morbidity
  • Participants who have symptoms defined as at least moderate pain or at least moderate stiffness during the screening period
  • Other protocol defined inclusion criteria may apply

Exclusion criteria

  • Metastatic TGCT or other active malignancy that requires treatment, or history of malignancy within 5 years prior to initiation of the screening period (excluding non-metastatic squamous cell carcinoma, basal cell carcinoma, or cervix carcinoma in situ with documented cure)
  • QT interval corrected by Fridericia's formula (QTcF) >450 ms in males or >470 ms in females, or history of long QT syndrome
  • Active liver or biliary disease, including nonalcoholic steatohepatitis (NASH) or cirrhosis
  • Other protocol defined exclusion criteria may apply

Treatment and study plan

DCC-3014

Drug

DCC-3014 will be orally administered at a dose of 30 mg twice weekly.

Primary outcomes

  1. ORR at Week 24

    Time frame: at Week 24

    Proportion of participants with a response of CR or PR based on independent radiological review, per RECIST v1.1

Secondary outcomes

  1. Adverse events

    Time frame: through study completion, an average of 3 year

    To assess the safety of DCC-3014 in Japanese patients with TGCT

  2. ORR per TVS (Tumor Volume Score) at Week 24

    Time frame: at Week 24

    Tumor response will be assessed by an independent radiological reviewer per TVS.

  3. Change from Baseline in Range of Motion (ROM) at Week 24

    Time frame: at Week 24

    Active and passive ROM of the affected and non-affected joints will be assessed

  4. Change from baseline in PROMIS Physical Function score at Week 24

    Time frame: at Week 24

    PROMIS(Patient-reported Outcomes Measurement Information System) Physical Function Score

  5. Change from baseline in the Worst Stiffness NRS score at Week 24

    Time frame: at Week 24

    NRS（Numeric rating scale） ranges from 0 to10, 0 is equivalent to no Stiffness and 10 indicates the worst possible Stiffness.

  6. Change from baseline in EQ-VAS (self-rated health scale) at Week 24

    Time frame: at Week 24

    The EQ-VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. EQ-VAS ranges from 0 to 100. Higher scores indicate better perceived health.

  7. Proportion of participants with at least 30% improvement in mean BPI Worst Pain NRS score, without a 30% or greater increase in narcotic analgesic use at Week 24

    Time frame: at Week 24

    BPI(Brief Pain Inventory) Worst Pain NRS ranges from 0 to10, 0 is equivalent to no pain and 10 indicates the worst possible pain.

  8. Best of response per RECIST v1.1

    Time frame: through study completion, an average of 3 year

  9. Best of response per TVS

    Time frame: through study completion, an average of 3 year

  10. Duration of response per RECIST v1.1

    Time frame: through study completion, an average of 3 year

  11. Duration of response per TVS

    Time frame: through study completion, an average of 3 year

  12. Plasma DCC-3014 concentration

    Time frame: from Week 0 to Week 24

  13. Plasma DP-7005 concentration

    Time frame: from Week 0 to Week 24

Interested in participating?

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Trial opening soon.

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Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase 2, Multicenter, Open-label, Non-controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of DCC-3014 in Japanese Subjects With Tenosynovial Giant Cell Tumor (TGCT)

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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