Study of DCC-2618 in Patients With GIST After at Least 3... | NCT07618377

Studies
Study of DCC-2618 in Patients With GIST After at Least 3 Prior Treatments

NCT07618377

Sponsor

Ono Pharmaceutical Co., Ltd.

Status

Not yet recruiting

Last Update Posted

Jun 1, 2026Actual

Enrollment

10Estimated

Phase

Phase 1

Conditions

Gastrointestinal Stromal Tumors

Interventions

DCC-2618

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2026Estimated

Primary Completion Date

Feb 2028Estimated

Completion Date

Feb 2028Estimated

First Submitted Date

May 25, 2026

First Submission Date that Met QC Criteria

May 25, 2026

First Posted Date

Jun 1, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2026

Last Update Posted Date

Jun 1, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DCC-2618	Experimental		Drug: DCC-2618

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DCC-2618	Drug	DCC-2618 150 mg, administered orally once daily	DCC-2618

Measure	Description	Time Frame
Adverse event (AE)		Up to 2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
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

Overall Officials

Name	Affiliation	Role
Project Leader	Ono Pharmaceutical Co., Ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cancer Center Hospital East		Kashiwa	Chiba		Japan
National Cancer Center Hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D046152	Gastrointestinal Stromal Tumors

Ancestor Terms

ID	Term
D009372	Neoplasms, Connective Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided