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New treatment option for GIST
Official title A Study of Inlexisertib (DCC-3116) in Combination With Anticancer Therapies in Participants With Advanced Malignancies
ClinicalTrials.gov ID: NCT05957367
What this study is testing
What is Inlexisertib?
Inlexisertib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for gist.
Also referred to as DCC-3116.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- Must not have received the following within the specified time periods prior to the first dose of study drug:
- Medications, including anticancer therapies, that are known strong or moderate inhibitors or inducers of CYP3A4 or P-glycoprotein (P-gp) including...
- Other anticancer therapies and any investigational therapies with a known safety and PK profile: 14 days or 5×the half-life of the medication...
- Investigational therapies with unknown safety and PK profile: 28 days. If there is enough data on the investigational therapy to assess the risk for...
- Grapefruit or grapefruit juice: 14 days
- Have not recovered from all clinically relevant toxicities from prior therapy
See the full eligibility 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
- Must not have received the following within the specified time periods prior to the first dose of study drug:
- 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...
- 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)
- 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...
- 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...
- 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...
- Major surgery within 4 weeks of the first dose of study drug
- Active HIV, Hepatitis B or Hepatitis C infection
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Miami, Florida, United States
- Worcester, Massachusetts, United States
- Grand Rapids, Michigan, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Fairfax, Virginia, United States
- Aarhus, Denmark
- Lille, France
- Paris, France
- Frankfurt, Germany
- Hamburg, Germany
- Florence, Italy
- Genova, Italy
- Milan, Italy
- Amsterdam, Netherlands
- Nijmegen, Netherlands
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Miami, Florida, United States; Worcester, Massachusetts, United States; Grand Rapids, Michigan, United States; St Louis, Missouri, United States; New York, New York, United States and 18 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.