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Study of Inlexisertib with Other Cancer Therapies for Advanced GIST

This study is testing a new drug, inlexisertib, in combination with other anti-cancer treatments like ripretinib, for people with advanced cancers. Specifically, it's looking at people with GIST (Gastrointestinal Stromal Tumor), a type of cancer that starts in the digestive tract, who have certain gene changes (KIT or PDGFRA mutations) and whose cancer has gotten worse on other treatments. The main goals are to see how safe the drug combinations are, find the best dose, and see if they shrink tumors. You must be at least 18 years old to participate. The study is currently open for enrollment for the GIST part.

Study design
This is a Phase 1/2, multi-center, open-label study, meaning you and your doctors will know which treatment you are receiving. It plans to enroll 94 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how well treatments work and any side effects for approximately 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05957367

A Study of Inlexisertib (DCC-3116) in Combination With Anticancer Therapies in Participants With Advanced Malignancies

Recruiting
PHASE1Ages 18+InterventionalTreatment
Deciphera Pharmaceuticals, LLC
~94 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:InlexisertibRipretinib

At a glance

Recruiting sites
28 of 28 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Adverse Events (Escalation Phase)
Measured over Approximately 24 months
+2 more outcomes measured

Conditions

GIST

Explore related trials

Gastrointestinal Stromal TumorKIT GenePDGFRA Gene

Where it's being run

28 sites across 18 states
Spain4
France3
Italy3
California2
Germany2
Netherlands2
Florida1
Massachusetts1

Study leadership

  • Clinical Team · STUDY_DIRECTOR · Deciphera Pharmaceuticals, LLC

Who to contact

Clinical Team
[email protected]
888-724-3274
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male or female ≥18 years of age
Module A: Part 1 and Part 2:
Module B: Only for Part 1 (Safety/Dose-finding):
Pathologically confirmed diagnosis of GIST with a KIT or platelet-derived growth factor receptor alpha (PDGFRA) mutation
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 not have received prior ripretinib treatment
Module B: Only for Part 2 (Expansion)
Pathologically confirmed GIST with documented mutation in KIT exon 11
Must have progressed on imatinib given in the locally advanced or metastatic setting or have been intolerant to imatinib and may not have received additional systemic therapy for GIST
Must have at least 1 measurable lesion according to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
Must have a life expectancy of more than 3 months and an ECOG performance status of 0-1
Adequate organ function and bone marrow reserve based on laboratory assessments performed at Screening
Must provide a fresh tumor biopsy, if able

Exclusion

Must not have received the following within the specified time periods prior to the first dose of study drug:
Have not recovered from all clinically relevant toxicities from prior therapy
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
Symptomatic central nervous system (CNS) metastases or presence of leptomeningeal disease
Malabsorption syndrome
Radiation for indications other than bone disease must have been completed 4 weeks prior to first dose of study drug, unless it consisted of limited field palliative radiation, including whole brain radiation, which must have been completed at least 2 weeks prior to first dose of study drug
Major surgery within 4 weeks of the first dose of study drug
Active HIV, Hepatitis B or Hepatitis C infection

What this trial measures

  • Incidence of Adverse Events (Escalation Phase)Approximately 24 months

    Identify the observed adverse events and serious adverse events associated with inlexisertib in combination with other anticancer therapies.

  • Recommended Phase 2 Doses (RP2D) (Escalation Phase)Approximately 18 months

    Identify the dose-limiting toxicities for each dose level tested and determine the recommended Phase 2 doses of inlexisertib in combination with other anticancer therapies.

  • Objective response rate (ORR) (Expansion Phase)Approximately 24 months

    Proportion of participants who achieve CR or PR per histology-specific consensus response criteria.