A Study of Inlexisertib (DCC-3116) in Combination With Anticancer Therapies in Participants With Advanced Malignancies
NCT ID: NCT05957367
Last Updated: 2026-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
94 participants
INTERVENTIONAL
2023-09-28
2029-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation (Part 1, Module A)
Escalation Module A Part 1 inlexisertib combination closed on January 8, 2024, with no participants enrolled.
Inlexisertib
Oral Tablet Formulation
Expansion (Part 2, Module A)
Expansion Module A Part 2 inlexisertib combination closed on January 8, 2024, with no participants enrolled.
Inlexisertib
Oral Tablet Formulation
Dose Escalation (Part 1, Module B)
Inlexisertib tablets in escalating dose cohorts in 28-day cycles will be administered in combination with ripretinib once daily (QD).
Inlexisertib
Oral Tablet Formulation
Ripretinib
Oral Tablet Formulation
Expansion (Part 2, Module B)
Inlexisertib tablets will be administered in combination with ripretinib in 28-day cycles to evaluate preliminary efficacy in participants with 2nd-line advanced gastrointestinal stromal tumor (GIST).
Inlexisertib
Oral Tablet Formulation
Ripretinib
Oral Tablet Formulation
Interventions
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Inlexisertib
Oral Tablet Formulation
Ripretinib
Oral Tablet Formulation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
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
18 Years
ALL
No
Sponsors
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Deciphera Pharmaceuticals, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Team
Role: STUDY_DIRECTOR
Deciphera Pharmaceuticals, LLC
Locations
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University of Southern California - Norris Comprehensive Cancer Center
Los Angeles, California, United States
UCLA Department of Medicine-Hematology/Oncology
Los Angeles, California, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
University of Massachusetts Worcester
Worcester, Massachusetts, United States
START Midwest
Grand Rapids, Michigan, United States
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Virginia Cancer Specialist, PC
Fairfax, Virginia, United States
Inselspital Universitätsklinikum Bern
Bern, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-516476-15-00
Identifier Type: CTIS
Identifier Source: secondary_id
DCC-3116-01-002
Identifier Type: -
Identifier Source: org_study_id
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