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

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

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Key information

Conditions

Gastrointestinal Stromal Tumors Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National Cancer Center Hospital East, Kashiwa, Chiba, Japan

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

DCC-2618

Drug

DCC-2618 150 mg, administered orally once daily

Primary outcomes

Adverse event (AE)

Time frame: Up to 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

International Clinical Trial Support Desk

CONTACT

[email protected]

+17162141777 (Standard)

North America Clinical Trial Support Desk

CONTACT

[email protected]

+18665877745 (Toll-Free)

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase 1 Study to Evaluate the Safety of DCC-2618 in Patients With Unresectable, Metastatic, or Recurrent Gastrointestinal Stromal Tumor (GIST) Who Are Refractory or Intolerant to at Least 3 Prior Therapies

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Jun 1, 2026
Registry last updated: Jul 20, 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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