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

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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07618377
Enrollment
10
Registered
2026-06-01
Start date
2026-07-07
Completion date
2028-02-01
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Stromal Tumors

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

Interventions

DRUGDCC-2618

DCC-2618 150 mg, administered orally once daily

Sponsors

Ono Pharmaceutical Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Participants with a histologically confirmed diagnosis of GIST. 2. Participants who are refractory or intolerant to treatment with at least imatinib, sunitinib, and regorafenib. 3. 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. 4. Participants with an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.

Exclusion criteria

1. Participants with a concomitant or prior history of severe hypersensitivity reactions to other tyrosine kinase inhibitors. 2. Participants with uncontrolled diabetes mellitus. 3. Participants with a systemic infection requiring treatment.

Design outcomes

Primary

MeasureTime frame
Adverse event (AE)Up to 2 years

Countries

Japan

Contacts

CONTACTNorth America Clinical Trial Support Desk
clinical_trial@ono-pharma.com+18665877745 (Toll-Free)
CONTACTInternational Clinical Trial Support Desk
clinical_trial@ono-pharma.com+17162141777 (Standard)
STUDY_DIRECTORProject Leader

Ono Pharmaceutical Co., Ltd.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 21, 2026