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.
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.
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.
Single group
ziftomenib
Drugmenin inhibitor
imatinib mesylate
Drugkinase inhibitor
Dose Escalation: Dose Limiting Toxicity (DLT)
Rate of DLTs per dose level
Descriptive statistics of Adverse Events (AEs)
Per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
Dose Expansion: Clinical benefit rate (CBR)
CBR is the rate of participants achieving complete response (CR), partial response (PR), or stable disease (SD), assessed per Response Criteria in Solid Tumors (RECIST) v1.1 modified for GIST
Recommended Phase 2 Dose Determination and Dose Expansion: CBR
CBR is CR + PR + SD assessed per RECIST v1.1 modified for GIST
Overall Response Rate (ORR)
ORR is CR + PR assessed per RECIST v1.1 modified for GIST
Progression Free Survival (PFS)
Assessed per RECIST v1.1 modified for GIST
Duration of Response (DoR)
Defined as the time from the first response (CR or PR assessed per RECIST v1.1 modified for GIST) to disease progression or death from any cause
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