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
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Japan
National Cancer Center Hospital East
RECRUITING
Kashiwa
National Cancer Center Hospital
RECRUITING
Tokyo
Contact Information
Primary
North America Clinical Trial Support Desk
clinical_trial@ono-pharma.com
+18665877745 (Toll-Free)
Backup
International Clinical Trial Support Desk
clinical_trial@ono-pharma.com
+17162141777 (Standard)
Time Frame
Start Date: 2026-07-07
Estimated Completion Date: 2028-02
Participants
Target number of participants: 10
Treatments
Experimental: DCC-2618
Related Therapeutic Areas
Sponsors
Leads: Ono Pharmaceutical Co., Ltd.