Actively Recruiting
A Study of Inlexisertib (DCC-3116) in Combination With Anticancer Therapies in Participants With Advanced Malignancies
Led by Deciphera Pharmaceuticals, LLC · Updated on 2026-05-01
94
Participants Needed
25
Research Sites
283 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Inlexisertib (DCC-3116) in Combination With Anticancer Therapies in Participants With Advanced Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 18 years of age or older
- For Module B Part 1: Pathologically confirmed GIST with KIT or PDGFRA mutation
- For Module B Part 1: Must have progressed on at least one approved systemic regimen or be intolerant to it
- For Module B Part 1: Must not have received prior ripretinib treatment
- For Module B Part 2: Pathologically confirmed GIST with KIT exon 11 mutation
- For Module B Part 2: Must have progressed on or be intolerant to imatinib and may not have received additional systemic therapy for GIST
- At least one measurable lesion according to mRECIST
- Life expectancy greater than 3 months
- ECOG performance status of 0-1
- Adequate organ function and bone marrow reserve based on screening labs
- Ability to provide a fresh tumor biopsy, if able
You will not qualify if you...
- Use of strong or moderate CYP3A4 or P-glycoprotein inhibitors or inducers within 14 days or 5 times the half-life of the medication
- Use of other anticancer or investigational therapies with known safety profiles within 14 days or 5 times the half-life
- Use of investigational therapies with unknown safety profiles within 28 days unless approved for shorter washout
- Consumption of grapefruit or grapefruit juice within 14 days
- Unresolved toxicities from prior therapy
- New York Heart Association Class III or IV heart disease, active ischemia, or uncontrolled cardiac conditions
- Clinically significant cardiac arrhythmia requiring therapy
- Uncontrolled hypertension, congestive heart failure, or myocardial infarction within 6 months
- Symptomatic central nervous system metastases or leptomeningeal disease
- Malabsorption syndrome
- Radiation therapy (except limited field palliative or whole brain radiation completed at least 2 weeks prior) within 4 weeks
- Major surgery within 4 weeks
- Active HIV, Hepatitis B, or Hepatitis C infection
AI-Screening
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Trial Site Locations
Total: 25 locations
1
University of Southern California - Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
2
UCLA Department of Medicine-Hematology/Oncology
Los Angeles, California, United States, 90095
Actively Recruiting
3
Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
4
University of Massachusetts Worcester
Worcester, Massachusetts, United States, 01655
Actively Recruiting
5
START Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
6
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, United States, 63110
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, United States, 10065
Actively Recruiting
8
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Actively Recruiting
9
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
10
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
11
Virginia Cancer Specialist, PC
Fairfax, Virginia, United States, 22031
Actively Recruiting
12
Aarhus University Hospital
Aarhus, Denmark, 8200
Actively Recruiting
13
Centre Oscar Lambret
Lille, France, 59020
Actively Recruiting
14
Hôpital Européen Georges Pompidou
Paris, France, 75015
Actively Recruiting
15
Universitatsklinikum Franfurt
Frankfurt, Germany, 60590
Actively Recruiting
16
Universitätsklinikum Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
17
AOU Careggi - Padiglione 16 - Piano Terra - Ambulatori Oncologici - Ufficio Trial
Florence, Italy, 50134
Actively Recruiting
18
Istituto Europeo di Oncologia
Milan, Italy, 20141
Actively Recruiting
19
Antonie Van Leeuwenhoek Hospital
Amsterdam, Netherlands, 1066 CX
Actively Recruiting
20
Radboudumc
Nijmegen, Netherlands, 6525GA
Actively Recruiting
21
Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E.
Porto, Portugal, 4200-072
Actively Recruiting
22
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Actively Recruiting
23
Hospital Universitario Clinico San Carlos
Madrid, Spain, 28040
Actively Recruiting
24
Hospital Universitario Virgen Del Rocio
Seville, Spain, 41013
Actively Recruiting
25
Inselspital Universitätsklinikum Bern
Bern, Switzerland, 3010
Actively Recruiting
Research Team
C
Clinical Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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