NCT07618377

Brief Summary

To evaluate the safety of DCC-2618 in patients with unresectable, metastatic, or recurrent gastrointestinal stromal tumor (GIST) who have received three or more prior therapies

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
19mo left

Started Jul 2026

Geographic Reach
1 country

2 active sites

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

May 25, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

June 1, 2026

Status Verified

May 1, 2026

Enrollment Period

1.6 years

First QC Date

May 25, 2026

Last Update Submit

May 25, 2026

Conditions

Gastrointestinal Stromal Tumors

Outcome Measures

Primary Outcomes (1)

  • Adverse event (AE)

    Up to 2 years

Study Arms (1)

DCC-2618

EXPERIMENTAL
Drug: DCC-2618

Interventions

DCC-2618DRUG

DCC-2618 150 mg, administered orally once daily

DCC-2618

Eligibility Criteria

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

You may qualify if:

  • Participants with a histologically confirmed diagnosis of GIST.
  • Participants who are refractory or intolerant to treatment with at least imatinib, sunitinib, and regorafenib.
  • Participants with at least one measurable lesion per the modified Response Evaluation Criteria in Solid Tumors (mRECIST) within 28 days prior to the first administration of the investigational product.
  • Participants with an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.

You may not qualify if:

  • Participants with a concomitant or prior history of severe hypersensitivity reactions to other tyrosine kinase inhibitors.
  • Participants with uncontrolled diabetes mellitus.
  • Participants with a systemic infection requiring treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Location

National Cancer Center Hospital

Tokyo, Chuo-ku, Japan

Location

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal 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 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2026

First Posted

June 1, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

June 1, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

JP(2)