OncoMatch/Clinical Trials/NCT05957367
A Study of Inlexisertib (DCC-3116) in Combination With Anticancer Therapies in Participants With Advanced Malignancies
Is NCT05957367 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Inlexisertib and Ripretinib for gist.
Treatment: Inlexisertib · Ripretinib — This is a Phase 1/2, multicenter, open-label (unless otherwise specified in a combination-specific module) study of inlexisertib in combination with anticancer therapies. Modules within the master protocol are defined according to different combinations of inlexisertib with other anticancer agents.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastrointestinal Stromal Tumor
Biomarker criteria
Required: KIT mutation
GIST with a KIT or platelet-derived growth factor receptor alpha (PDGFRA) mutation
Required: PDGFRA mutation
GIST with a KIT or platelet-derived growth factor receptor alpha (PDGFRA) mutation
Required: KIT exon 11 mutation
GIST with documented mutation in KIT exon 11
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy — locally advanced or metastatic
Must have progressed on at least one approved systemic regimen given in the locally advanced or metastatic setting or have documented intolerance to it
Must have received: tyrosine kinase inhibitor (imatinib) — locally advanced or metastatic
Must have progressed on imatinib given in the locally advanced or metastatic setting or have been intolerant to imatinib
Cannot have received: tyrosine kinase inhibitor (ripretinib)
Must not have received prior ripretinib treatment
Cannot have received: systemic therapy
Exception: May not have received additional systemic therapy for GIST after imatinib
may not have received additional systemic therapy for GIST
Lab requirements
Blood counts
Adequate bone marrow reserve based on laboratory assessments performed at Screening
Kidney function
Adequate organ function based on laboratory assessments performed at Screening
Liver function
Adequate organ function based on laboratory assessments performed at Screening
Cardiac function
No New York Heart Association Class III or IV heart disease, active ischemia, or any other uncontrolled cardiac condition, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension, congestive heart failure, or myocardial infarction within 6 months prior to the first dose of study drug
Adequate organ function and bone marrow reserve based on laboratory assessments performed at Screening; New York Heart Association Class III or IV heart disease, active ischemia, or any other uncontrolled cardiac condition, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension, congestive heart failure, or myocardial infarction within 6 months prior to the first dose of study drug [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Southern California - Norris Comprehensive Cancer Center · Los Angeles, California
- UCLA Department of Medicine-Hematology/Oncology · Los Angeles, California
- Sylvester Comprehensive Cancer Center · Miami, Florida
- University of Massachusetts Worcester · Worcester, Massachusetts
- START Midwest · Grand Rapids, Michigan
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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