NCT06655246 · Kura Oncology, Inc.
A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
What this study is about
In this clinical trial, the safety, tolerability, and preliminary antitumor activity of ziftomenib in combination with imatinib will be evaluated in adults with gastrointestinal stromal tumors (GIST) who have been treated previously with imatinib.
View original scientific description
In this clinical trial, the safety, tolerability, and preliminary antitumor activity of ziftomenib in combination with imatinib will be evaluated in adults with gastrointestinal stromal tumors (GIST) who have been treated previously with imatinib.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Documented diagnosis of advanced/metastatic KIT-mutant GIST.
- Documented disease progression on imatinib as current or prior therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 at screening.
- At least 1 measurable lesion per RECIST v1.1 modified for GIST.
- Negative pregnancy test for participants of childbearing potential.
- Adequate organ function per protocol requirements.
- Resolution of all clinically significant toxicities from prior therapy to \<Grade 1 (or participant baseline) within 1 week before the first dose of study intervention.
- Participant, or legally authorized representative, must be able to understand and provide written informed consent before the first screening procedure. Key
Exclusion criteria
- Diagnosis of GIST without a KIT mutation or with a T670X KIT mutation.
- History of prior or current cancer that has potential to interfere with obtaining study results.
- Received a prohibited medication, including investigational therapy, less than 14 days or within 5 drug half-lives before the first dose of study intervention.
- Active central nervous system metastases.
- Uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease.
- Mean corrected QT interval (QTcF) greater than 470ms.
- Left ventricular ejection fraction (LVEF) \<50%.
- Major surgery within 2 weeks before the first dose of study intervention.
- Is pregnant or breastfeeding.
- Gastrointestinal abnormalities that may impact taking study intervention by mouth.
- Actively bleeding, excluding hemorrhoidal or gum bleeding.
Where
- Birmingham, Alabama
- Phoenix, Arizona
- La Jolla, California
- Los Angeles, California
- Orange, California
- Palo Alto, California
- Santa Monica, California
- Aurora, Colorado
- Denver, Colorado
- New Haven, Connecticut
- Jacksonville, Florida
- Miami, Florida
And 17 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 5, 2026 · Source of record for eligibility and locations