A Study of Ziftomenib, an Oral Menin Inhibitor, in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)

Launched by KURA ONCOLOGY, INC. · Oct 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ziftomenib, which is taken by mouth, to see how well it works when combined with another medication called imatinib for patients with advanced gastrointestinal stromal tumors (GIST). GIST is a type of cancer that affects the digestive system. The trial aims to find out if this combination is safe, tolerable, and if it can help slow down or stop the growth of the tumors in adults who have already been treated with imatinib but saw their cancer get worse.

To be eligible for this study, participants need to have a confirmed diagnosis of advanced GIST with a specific genetic mutation (KIT mutant), and they must have experienced disease progression while on imatinib. Other requirements include being in relatively good health, with a performance status that allows them to carry out daily activities, and having at least one measurable tumor. If someone decides to participate, they will receive the new treatment and be closely monitored for any side effects and how well the treatment is working. It's important to note that certain health conditions, such as uncontrolled illnesses or recent major surgeries, may prevent someone from joining the trial.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Documented diagnosis of advanced or metastatic KIT mutant GIST.
• • Documented disease progression on imatinib therapy as current or prior treatment.
• • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤2 at screening.
• • At least 1 measurable lesion per mRECIST.
• • Negative pregnancy test for female patients of childbearing potential.
• • Adequate organ function per protocol requirements.
• • Resolution of all clinically significant toxicities from prior therapy to ≤Grade 1 (or patient baseline) within 1 week prior to the first dose of study drug.
• • Participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure.
• Key Exclusion Criteria:
• • Diagnosis of non-KIT mutation or a T670X KIT mutation-driven GIST.
• • History of prior or currently has cancer which 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 prior to 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 prior to the first dose of study intervention.
• • Is pregnant or lactating.
• • Gastrointestinal abnormalities that may impact taking study intervention by mouth.
• • Actively bleeding, excluding hemorrhoidal or gum bleeding.