GISTPhase 1/2NCT05957367
A Study of Inlexisertib (DCC-3116) in Combination With Anticancer Therapies in Participants With Advanced Malignancies
A Phase 1/2 study testing Inlexisertib and Ripretinib in people with GIST, run by Deciphera Pharmaceuticals, LLC at 28 sites in 9 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GIST
- What is being tested?
- Inlexisertib and Ripretinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 28 sitesin 9 countries
- Study dates
- 28 Sep 2023to Mar 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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 half-life of the medication (whichever is longer)
- 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, the Sponsor's Medical Monitor may approve a shorter washout of 14 days
- Grapefruit or grapefruit juice: 14 days
- Have not recovered from all clinically relevant toxicities from prior therapy
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- 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
Trial locations and contacts
28 sites in 9 countries.
28 sites in 9 countries
United States11 sites
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Virginia Cancer Specialist, PC
Fairfax, Virginia, 22031
START Midwest
Grand Rapids, Michigan, 49546
University of Southern California - Norris Comprehensive Cancer Center
Los Angeles, California, 90033
UCLA Department of Medicine-Hematology/Oncology
Los Angeles, California, 90095
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, 10065
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Oregon Health & Science University
Portland, Oregon, 97239
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, 63110
University of Massachusetts Worcester
Worcester, Massachusetts, 01655
Spain4 sites
ICO Hospitalet
Barcelona, 08908
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Universitario Clinico San Carlos
Madrid, 28040
Hospital Universitario Virgen Del Rocio
Seville, 41013
France3 sites
Centre Oscar Lambret
Lille, 59020
Institut Curie, Service d'Oncologie Médicale
Paris, 75005
Hôpital Européen Georges Pompidou
Paris, 75015
Italy3 sites
AOU Careggi - Padiglione 16 - Piano Terra - Ambulatori Oncologici - Ufficio Trial
Florence, 50134
IRCCS Azienda Ospedaliera Metropolitana
Genova, 16132
Istituto Europeo di Oncologia
Milan, 20141
Germany2 sites
Universitatsklinikum Franfurt
Frankfurt, 60590
Universitätsklinikum Eppendorf
Hamburg, 20246
Netherlands2 sites
Antonie Van Leeuwenhoek Hospital
Amsterdam, 1066 CX
Radboudumc
Nijmegen, 6525GA
Portugal1 site
Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E.
Porto, 4200-072
About this study
Official title: A Master Protocol for the Multi-Cohort, Phase 1/2 Study of DCC-3116 in Combination With Anticancer Therapies in Participants With Advanced Malignancies
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
- GIST
- Being tested
- Inlexisertib, Ripretinib
- Keywords
- Advanced gastrointestinal stromal tumors, gastrointestinal stromal tumors, ripretinib
- Medical subject headings
- Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InlexisertibDrug
Also called DCC-3116
Oral Tablet Formulation
RipretinibDrug
Also called QINLOCK, DCC-2618
Oral Tablet Formulation
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation (Part 1, Module A) | Experimental | Escalation Module A Part 1 inlexisertib combination closed on January 8, 2024, with no participants enrolled. Receives: Drug: Inlexisertib |
| Expansion (Part 2, Module A) | Experimental | Expansion Module A Part 2 inlexisertib combination closed on January 8, 2024, with no participants enrolled. Receives: Drug: Inlexisertib |
| Dose Escalation (Part 1, Module B) | Experimental | Inlexisertib tablets in escalating dose cohorts in 28-day cycles will be administered in combination with ripretinib once daily (QD). Receives: Drug: Inlexisertib; Drug: Ripretinib |
| Expansion (Part 2, Module B) | Experimental | 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). Receives: Drug: Inlexisertib; Drug: Ripretinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (Escalation Phase)
Identify the observed adverse events and serious adverse events associated with inlexisertib in combination with other anticancer therapies.
Measured: Approximately 24 months
Recommended Phase 2 Doses (RP2D) (Escalation Phase)
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.
Measured: Approximately 18 months
Objective response rate (ORR) (Expansion Phase)
Proportion of participants who achieve CR or PR per histology-specific consensus response criteria.
Measured: Approximately 24 months
Secondary outcomes (9)
Duration of response (DoR)
DoR is defined as the time interval from the time that the measurement criteria are first met for CR or PR (whichever is first recorded) per histology-specific consensus response criteria until the first date that the progressive disease is objectively documented or death, whichever occurs first.
Measured: Approximately 24 months
Disease Control Rate (DCR)
The DCR is defined as the proportion of participants who achieve CR, PR, or stable disease (SD) per histology-specific consensus response criteria.
Measured: Approximately 24 months
Time to response
Time to response is defined as the time from initiation of treatment until the first assessment demonstrating CR or PR per histology-specific consensus response criteria.
Measured: Approximately 24 months
Progression-free survival (PFS)
PFS is defined as the time from initiation of treatment until documented disease progression per histology-specific consensus response criteria or death, whichever occurs first.
Measured: Approximately 24 months
Overall Survival (OS)
OS is defined as the time from initiation of treatment until death.
Measured: Approximately 48 months
Maximum observed concentration (Cmax)
Measure the maximum observed concentration of inlexisertib combinations.
Measured: Predose and up to 12 hours postdose
Time to maximum observed concentration (Tmax)
Measure the time to maximum plasma concentration of inlexisertib combinations.
Measured: Predose and up to 12 hours postdose
Minimum observed concentration (Cmin)
Measure the minimum observed concentration of inlexisertib combinations.
Measured: Predose and up to 12 hours postdose
Area under the concentration-time curve (AUC)
Measure the AUC of inlexisertib combinations.
Measured: Predose and up to 12 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start28 Sep 2023
- Primary completionMar 2027 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GISTStudies of the same condition, open and under way.
- More trials run by Deciphera Pharmaceuticals, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deciphera Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Team, Study director, Deciphera Pharmaceuticals, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957367
- Sponsor's protocol ID
- DCC-3116-01-002
- Other IDs
- 2024-516476-15-00
- Status last verified
- Oct 2026
- First submitted
- 14 Jul 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Master Protocol for the Multi-Cohort, Phase 1/2 Study of DCC-3116 in Combination With Anticancer Therapies in Participants With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT05957367
- Acronym / sponsor ID
- DCC-3116-01-002
- Conditions
- GIST
- Keywords
- Advanced gastrointestinal stromal tumors, gastrointestinal stromal tumors, ripretinib
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Deciphera Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation (Part 1, Module A) | Experimental | Drug: InlexisertibEscalation Module A Part 1 inlexisertib combination closed on January 8, 2024, with no participants enrolled. |
| Expansion (Part 2, Module A) | Experimental | Drug: InlexisertibExpansion Module A Part 2 inlexisertib combination closed on January 8, 2024, with no participants enrolled. |
| Dose Escalation (Part 1, Module B) | Experimental | Drug: Inlexisertib, Drug: RipretinibInlexisertib tablets in escalating dose cohorts in 28-day cycles will be administered in combination with ripretinib once daily (QD). |
| Expansion (Part 2, Module B) | Experimental | Drug: Inlexisertib, Drug: RipretinibInlexisertib 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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):
- Module B: Only for Part 2 (Expansion)
Key exclusion criteria (12 listed)
- Must not have received the following within the specified time periods prior to the first dose of study drug:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InlexisertibAlso: DCC-3116Oral Tablet Formulation | Drug | Dose Escalation (Part 1, Module A), Dose Escalation (Part 1, Module B), Expansion (Part 2, Module A), Expansion (Part 2, Module B) |
| RipretinibAlso: QINLOCK, DCC-2618Oral Tablet Formulation | Drug | Dose Escalation (Part 1, Module B), Expansion (Part 2, Module B) |
Primary outcome
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.
9 secondary outcomes
Duration of response (DoR)
Time frame: Approximately 24 months
Disease Control Rate (DCR)
Time frame: Approximately 24 months
Time to response
Time frame: Approximately 24 months
Progression-free survival (PFS)
Time frame: Approximately 24 months
Overall Survival (OS)
Time frame: Approximately 48 months
Maximum observed concentration (Cmax)
Time frame: Predose and up to 12 hours postdose
Time to maximum observed concentration (Tmax)
Time frame: Predose and up to 12 hours postdose
Minimum observed concentration (Cmin)
Time frame: Predose and up to 12 hours postdose
Area under the concentration-time curve (AUC)
Time frame: Predose and up to 12 hours postdose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Team study director
Deciphera Pharmaceuticals, LLC
28 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Inlexisertib and Ripretinib in people with GIST, run by Deciphera Pharmaceuticals, LLC at 28 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Spain, France, Italy, Germany and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (Escalation Phase) (time frame: Approximately 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.