CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 94 target
Drug / intervention
Inlexisertib +1 moredrug
Likely dose
Not stated in record
Key inclusion· 12
  • ✓Male or female ≥18 years of age
  • ✓Module B Part 1: Pathologically confirmed GIST with KIT or PDGFRA mutation
  • ✓Module B Part 1: Progressed on at least one approved systemic regimen in locally advanced/metastatic setting or documented intolerance
  • ✓Module B Part 1: No prior ripretinib treatment
Key exclusion· 13
  • ✕CYP3A4/P-gp inhibitors or inducers within 14 days or 5× half-life (whichever longer)
  • ✕Other anticancer/investigational therapies (known PK) within 14 days or 5× half-life (whichever shorter)
  • ✕Investigational therapies (unknown PK) within 28 days (or 14 days if approved)
  • ✕Grapefruit/grapefruit juice within 14 days

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05957367
NCT05957367Phase 2RecruitingHigh Momentum
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A Master Protocol for the Multi-Cohort, Phase 1/2 Study of DCC-3116 in Combination With Anticancer Therapies in Participants With Advanced Malignancies

Deciphera Pharmaceuticals, LLC·interventional·Posted Jul 24, 2023·Updated Jun 2, 2026

In Brief

A Phase 2 clinical trial evaluating Inlexisertib and Ripretinib for GIST. Currently recruiting, targeting 94 participants across 26 sites in 9 countries.

Signals

Enrolling ahead of pace

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGIST
CountriesDenmark, France, Germany, Italy, Netherlands, Portugal, Spain, Switzerland, United States
Collaborators--

Timeline

Phase 2Recruiting
202420252026202720282029
First PostedJul 24, 2023
Enrollment StartSep 28, 2023
Primary CompletionMar 1, 2027
Study CompletionMar 1, 2029
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 2.9 years agoPrimary completion in 8 months

Interventions

Inlexisertibdrug

Oral Tablet Formulation

Ripretinibdrug

Oral Tablet Formulation