IRB #

STUDY00021229

Title

Phase 1, Multicenter, Open-Label, First-in-Human Study of DS-6157a in Patients with Advanced Gastrointestinal Stromal Tumor

Principal Investigator

Michael Heinrich

Study Purpose

The purpose of this study is the test the safety and tolerability of a study drug called DS-6157a as a single agent in participants with Gastrointestinal Stromal Tumors (GIST). The study drug has been tested in animals, but not people.

Medical Condition(s)

PDGFRa D842V mutant GIST

Eligibility Criteria

1. >18 years old
2. Dose Expansion Cohort 1: subjects with GIST who have progressed on or are intolerant to IM and at least one post-imatinib treatment
3. Dose Expansion Cohort 2: subjects with GIST who have progressed on IM and have not received a post-IM treatment (2nd line)
4. Tests, procedures and a complete review of medical history will be done to confirm eligibility.

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

You will receive the study drug as long as you are tolerating the drug well and benefiting from the treatment based on the assessments of the study doctor. After you finish study treatment your doctor will continue to watch you for side effects and follow your condition for at least 30 days after last dose of study treatment. Afterwards, you will be followed every 6 weeks for the first 9 months and then every 9 weeks until your disease worsens, you start a new anti-cancer therapy or death.

Minors Included

No

Contact

Knight Clinical Trials Information Line
Phone: 503-494-1080
Email: trials@ohsu.edu

Sponsor

Daiichi Sankyo Inc.

Recruitment End

03/31/2025

Compensation Provided

No


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