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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Kura Oncology, Inc.
Study ID
NCT06655246
Phase
PHASE1
Status
Recruiting
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Conditions

  • Gastrointestinal Stromal Cancer
  • Gastrointestinal Stromal Cell Tumors
  • Gastrointestinal Stromal Neoplasm
  • Gastrointestinal Stromal Tumor (GIST)
  • Gastrointestinal Stromal Tumor, Malignant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ziftomenib — DRUG
    menin inhibitor
  • imatinib mesylate — DRUG
    kinase inhibitor

Study Details

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.

Key Dates

Start date
Mar 27, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
157 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    Ziftomenib plus imatinib
  • Experimental: Recommended Phase 2 Dose Determination
    Ziftomenib plus imatinib
  • Experimental: Dose Expansion
    Ziftomenib plus imatinib

Primary Outcome Measure

Dose Escalation: Dose Limiting Toxicity (DLT) [ Time Frame: Cycle 1 (first 28 day cycle) ]

Central Contacts

Locations (32)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233-
Mayo Clinic Cancer CenterPhoenixArizona85054-
University of California, San DiegoLa JollaCalifornia92093-
University of Southern CaliforniaLos AngelesCalifornia90033-
University Of California, IrvineOrangeCalifornia92868-
Stanford Cancer InstitutePalo AltoCalifornia94304-
UCLA Santa Monica Medical CenterSanta MonicaCalifornia90404-
University of Colorado Cancer CenterAuroraColorado80045-
Sarah Cannon Research InstituteDenverColorado80220-
Yale University School of MedicineNew HavenConnecticut06511-
Mayo Clinic Cancer CenterJacksonvilleFlorida32224-
University of MiamiMiamiFlorida33136-
Northwestern UniversityChicagoIllinois60611-
University of IowaIowa CityIowa52242-
Johns Hopkins UniversityBaltimoreMaryland21287-
Harvard UniversityBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
University of MichiganAnn ArborMichigan48109-
Mayo Clinic Cancer CenterRochesterMinnesota55905-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
Duke University Medical CenterDurhamNorth Carolina27710-
Ohio State UniversityColumbusOhio43210-
Oregon Health & Science UniversityPortlandOregon97239-
Temple University Health SystemPhiladelphiaPennsylvania19111-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
Sarah Cannon Research InstituteNashvilleTennessee37203-
Vanderbilt University Medical CenterNashvilleTennessee37232-
Sarah Cannon Research InstituteDallasTexas75230-
University of TexasHoustonTexas77030-
University of Texas Health Science CenterSan AntonioTexas78229-
University of UtahSalt Lake CityUtah84112-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALMayo Clinic Cancer Center· Phoenix, AZUniversity of California, San Diego· La Jolla, CAUniversity of Southern California· Los Angeles, CAUniversity Of California, Irvine· Orange, CAStanford Cancer Institute· Palo Alto, CA

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