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Combining inlexisertib with cancer therapies for advanced GIST

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

Phase1; Phase2 Interventional Deciphera Pharmaceuticals, LLC · NCT05957367

This study is testing a new drug called inlexisertib combined with other cancer treatments to see if it can help people with advanced gastrointestinal stromal tumors who haven't responded well to standard therapies.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment94 (estimated)
Ages18 Years and up
SexAll
SponsorDeciphera Pharmaceuticals, LLC Industry-sponsored
Drugs / interventionsripretinib, imatinib, Radiation
Locations25 sites (Los Angeles, California and 24 other locations)
Trial IDNCT05957367 on ClinicalTrials.gov

What this trial studies

This Phase 1/2 clinical trial evaluates the safety and efficacy of inlexisertib in combination with other anticancer therapies for patients with advanced gastrointestinal stromal tumors (GIST). The study is structured into modules that explore different combinations of inlexisertib with other treatments, focusing on patients who have progressed on or are intolerant to standard therapies. Participants will be monitored for their response to treatment and any adverse effects, with the goal of identifying effective combinations for this challenging cancer.

Who should consider this trial

Good fit: Ideal candidates include adults with pathologically confirmed GIST who have specific mutations and have progressed on or are intolerant to prior therapies.

Not a fit: Patients who have not been diagnosed with GIST or those who have received prior treatment with ripretinib may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new treatment options for patients with advanced GIST who have limited alternatives.

How similar studies have performed: Other studies have shown promise in combining targeted therapies for GIST, but this specific combination approach is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Male or female ≥18 years of age
* Module A: Part 1 and Part 2:

Module A Part 1 and Part 2 inlexisertib combination closed on January 8, 2024, with no participants enrolled.

* 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 Criteria:

* Must not have received the following within the specified time periods prior to the first dose of study drug:

  1. Medications, including anticancer therapies, that are known strong or moderate inhibitors or inducers of CYP3A4 or P-glycoprotein (P-gp) including certain herbal medications (eg, St. John's wort): 14 days or 5×the half-life of the medication (whichever is longer)
  2. Other anticancer therapies and any investigational therapies with a known safety and PK profile: 14 days or 5×the half-life of the medication (whichever is shorter)
  3. Investigational therapies with unknown safety and PK profile: 28 days. If there is enough data on the investigational therapy to assess the risk for drug-drug interactions and late toxicities of prior therapy as low, the Sponsor's Medical Monitor may approve a shorter washout of 14 days
  4. Grapefruit or grapefruit juice: 14 days
* 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

Where this trial is running

Los Angeles, California and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions GISTAdvanced gastrointestinal stromal tumorsgastrointestinal stromal tumorsripretinib
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.