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Clinical Trials in Japan / NCT07618377
Recruiting Phase 1

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

NCT07618377 · tracked via the Priya Life Science Japan tracker
Sponsor
Ono Pharmaceutical Co., Ltd
Phase
Phase 1
Started
2026-07-07
Last updated
2026-07-20

Condition(s) studied

Gastrointestinal Stromal Tumors

Investigational drug(s) / intervention(s)

DCC-2618 →

DCC-2618: DCC-2618 150 mg, administered orally once daily

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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.

Primary outcome measure(s)

  • Adverse event (AE) — Up to 2 years

Trial sites (2)

FacilityCityRegionStatus
National Cancer Center Hospital East Kashiwa Chiba Recruiting
National Cancer Center Hospital Tokyo Chuo-ku Recruiting

More Ono Pharmaceutical Co., Ltd. trials in Japan

A Study of ONO-2020 in Patients With Agitation Associated With Alzheimer's Disease Dementia Recruiting
The Study of ONO-7913, ONO-4538 and the Standard of Care as First-line Treatment in Patients Colorectal Cancer Active, not recruiting
A Phase I Study of ONO-4538HSC in Subjects With Advanced or Metastatic Solid Tumors Active, not recruiting
INTREPID: A Study of Sapablursen Evaluating the Safety and Efficacy in Participants With Polycythemia Vera (PV) Recruiting
Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures Recruiting

Other trials for the same condition

A Study of Pimitespib in Combination With Imatinib in Patients With GIST (CHAPTER-GIST-101) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07618377 on ClinicalTrials.gov ↗ ← All trials in Japan