NCT05957367 · Deciphera Pharmaceuticals, LLC
A Study of Inlexisertib (DCC-3116) in Combination With Anticancer Therapies in Participants With Advanced Malignancies
What this study is about
This is a Phase 1/2, conducted at multiple hospitals, where both patients and doctors know the treatment given (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.
View original scientific description
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.
Interventions
DRUG
Inlexisertib
Oral Tablet Formulation
DRUG
Ripretinib
Oral Tablet Formulation
Primary outcome measures
Incidence of Adverse Events (Escalation Phase)
Time frame: Approximately 24 months
Identify the observed adverse events and serious adverse events associated with inlexisertib in combination with other anticancer therapies.
Recommended Phase 2 Doses (RP2D) (Escalation Phase)
Time frame: Approximately 18 months
Identify the dose-limiting toxicities for each dose level tested and determine the recommended Phase 2 doses of inlexisertib in combination with other anticancer therapies.
Objective response rate (ORR) (Expansion Phase)
Time frame: Approximately 24 months
Proportion of participants who achieve CR or PR per histology-specific consensus response criteria.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 (mRE
Where
- Los Angeles, California
- Miami, Florida
- Worcester, Massachusetts
- Grand Rapids, Michigan
- St Louis, Missouri
- New York, New York
- Cleveland, Ohio
- Portland, Oregon
- Philadelphia, Pennsylvania
- Fairfax, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 13, 2026 · Source of record for eligibility and locations