A Study of Inlexisertib (DCC-3116) in Combination With Anticancer Therapies in Participants With Advanced Malignancies
Recruiting
Phase 1Phase 2Interventional Study
GIST
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
94 (estimated)
Sponsor
Deciphera Pharmaceuticals, LLC · Industry
Who this trial is looking for
This trial is looking for adults with a type of cancer called GIST. Participants will take a drug called inlexisertib along with other cancer treatments to see how well it works.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with GIST with specific mutations.
I have experienced cancer progression with previous treatments.
I have at least one measurable lesion.
I expect to live more than 3 months.
I have good organ function.
I can provide a fresh tumor biopsy, if possible.
You may not be able to join if
I have had major heart issues or uncontrolled high blood pressure.
I have active central nervous system metastases.
I have not fully recovered from side effects of previous treatments.
I have had major surgery in the last 4 weeks.
I currently have active HIV, Hepatitis B or Hepatitis C.
I cannot take certain medications or grapefruit juice before starting the trial.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
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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.
Trial Locations
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Status
Eligibility 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 wit…
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
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