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Trial NCT06655246

A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)

Phase
Phase 1
Sponsor
Kura Oncology, Inc.
Conditions
Gastrointestinal Stromal Tumor (GIST); Gastrointestinal Stromal Cancer; Gastrointestinal Stromal Neoplasm; Gastrointestinal Stromal Tumor, Malignant; Gastrointestinal Stromal Cell Tumors
Ages
18+ years
View on ClinicalTrials.gov ↗

Eligibility criteria

Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).

Key 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.Performance status * 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.Prior malignancy * 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.Brain metastases * Uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease. * Mean corrected QT interval (QTcF) greater than 470ms.Cardiac * Left ventricular ejection fraction (LVEF) <50%. * Major surgery within 2 weeks before the first dose of study intervention. * Is pregnant or breastfeeding.Pregnancy * Gastrointestinal abnormalities that may impact taking study intervention by mouth. * Actively bleeding, excluding hemorrhoidal or gum bleeding.

Restrictions found (5)

Recruiting in Massachusetts

  • Massachusetts General Hospital · Boston, Suffolk County
  • Harvard University · Boston, Suffolk County