NCT07832747

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
44mo left

Started Oct 2026

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 22, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

October 31, 2026

Expected
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2030

Last Updated

September 22, 2026

Status Verified

September 1, 2026

Enrollment Period

1.8 years

First QC Date

September 8, 2026

Last Update Submit

September 15, 2026

Conditions

Tenosynovial Giant Cell Tumor

Outcome Measures

Primary Outcomes (1)

  • ORR at Week 24

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

    at Week 24

Secondary Outcomes (13)

  • Adverse events

    through study completion, an average of 3 year

  • ORR per TVS (Tumor Volume Score) at Week 24

    at Week 24

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

    at Week 24

  • Change from baseline in PROMIS Physical Function score at Week 24

    at Week 24

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

    at Week 24

  • +8 more secondary outcomes

Study Arms (1)

DCC-3014

EXPERIMENTAL
Drug: DCC-3014

Interventions

DCC-3014DRUG

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

DCC-3014

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Institute Hospital of JFCR

Tokyo, Koto, 135-8550, Japan

Location

MeSH Terms

Conditions

Giant Cell Tumor of Tendon Sheath

Condition Hierarchy (Ancestors)

Giant Cell TumorsNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSynovitisJoint DiseasesMusculoskeletal DiseasesTendinopathyMuscular Diseases

Study Officials

  • Project Leader

    Ono Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Central Study Contacts

North America Clinical Trial Support Desk

CONTACT

+18665877745 (Toll-Free)clinical_trial@ono-pharma.com

International Clinical Trial Support Desk

CONTACT

+17162141777 (Standard)clinical_trial@ono-pharma.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2026

First Posted

September 22, 2026

Study Start (Estimated)

October 31, 2026

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

May 31, 2030

Last Updated

September 22, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)