NCT07618377 Study of DCC-2618 in Patients With GIST After at Least 3 Prior Treatments
| NCT ID | NCT07618377 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Ono Pharmaceutical Co., Ltd. |
| Condition | Gastrointestinal Stromal Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2026-07-07 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2026-07-07 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility 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: 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.
Contact & Investigator
North America Clinical Trial Support Desk
✉ clinical_trial@ono-pharma.com📞 +18665877745 (Toll-Free)
Project Leader
STUDY DIRECTOR
Ono Pharmaceutical Co., Ltd.
Frequently Asked Questions
Who can join the NCT07618377 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastrointestinal Stromal Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07618377 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07618377 currently recruiting?
Yes, NCT07618377 is actively recruiting participants. Contact the research team at clinical_trial@ono-pharma.com for enrollment information.
Where is the NCT07618377 trial being conducted?
This trial is being conducted at Kashiwa, Japan, Tokyo, Japan.
Who is sponsoring the NCT07618377 clinical trial?
NCT07618377 is sponsored by Ono Pharmaceutical Co., Ltd.. The principal investigator is Project Leader at Ono Pharmaceutical Co., Ltd.. The trial plans to enroll 10 participants.