A domestic Phase I study of DCC-2618 in patients with gastrointestinal stromal tumor (GIST) who are refractory or intolerant to three or more prior therapies

A domestic Phase I 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 three or more prior therapies

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031260153

Enrollment

Registered

2026-05-25

Start date

2026-07-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Gastrointestinal stromal tumor that progressed after anticancer chemotherapy

Interventions

DCC-2618 150 mg, administered orally once daily.

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Measure	Time frame
Safety	—

Contacts

Public ContactSupport Desk JP

Ono Pharmaceutical Co.,LTD.

clinical_trial@ono-pharma.com+81-120278120

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026