A Study of Inlexisertib (DCC-3116) in Combination With Anticancer Therapies in Participants With Advanced Malignancies

June 1, 2026 updated by: Deciphera Pharmaceuticals, LLC

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

94

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Recruiting
        • Aarhus University Hospital
        • Contact:
        • Principal Investigator:
          • Ninna Aggerholm Pedersen, MD
  • France
      • Lille, France, 59020
        • Recruiting
        • Centre Oscar Lambret
        • Principal Investigator:
          • Loic Lebellec, MD
        • Contact:
      • Paris, France, 75015
        • Recruiting
        • Hopital Europeen Georges Pompidou
        • Contact:
          • Phone Number: +33156092802
        • Principal Investigator:
          • Widad Lahlou, MD
  • Germany
      • Frankfurt, Germany, 60590
        • Recruiting
        • Universitatsklinikum Franfurt
        • Contact:
        • Principal Investigator:
          • Marit Ahrens, MD
      • Hamburg, Germany, 20246
        • Recruiting
        • Universitätsklinikum Eppendorf
        • Contact:
        • Principal Investigator:
          • Jana Striefler, MD
  • Italy
      • Florence, Italy, 50134
        • Recruiting
        • AOU Careggi - Padiglione 16 - Piano Terra - Ambulatori Oncologici - Ufficio Trial
        • Principal Investigator:
          • Lorenzo Antonuzzo, MD
        • Contact:
      • Genova, Italy, 16132
        • Recruiting
        • IRCCS Azienda Ospedaliera Metropolitana
        • Contact:
        • Principal Investigator:
          • Danila Comandini, MD
      • Milan, Italy, 20141
        • Recruiting
        • Istituto Europeo di Oncologia
        • Principal Investigator:
          • Elisabetta Setola, MD
        • Contact:
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Recruiting
        • Antonie Van Leeuwenhoek Hospital
        • Principal Investigator:
          • Neeltje Steeghs, MD
        • Contact:
          • Phone Number: +31205122103
      • Nijmegen, Netherlands, 6525GA
        • Recruiting
        • Radboudumc
        • Principal Investigator:
          • Ingrid Desar, MD
        • Contact:
          • Phone Number: +31 (0)6 3113 6977
  • Portugal
      • Porto, Portugal, 4200-072
        • Recruiting
        • Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E.
        • Contact:
        • Principal Investigator:
          • Miguel Abreu, MD
  • Spain
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramón y Cajal
        • Principal Investigator:
          • Maria Angeles Vaz Salgado, MD
        • Contact:
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario Clínico San Carlos
        • Contact:
        • Principal Investigator:
          • Gloria Marquina Ospina, MD
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio
        • Contact:
        • Principal Investigator:
          • Maria Pilar Sancho Marquez, MD
  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • Inselspital Universitätsklinikum Bern
        • Principal Investigator:
          • Attila Kollar, MD
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • University of Southern California - Norris Comprehensive Cancer Center
        • Principal Investigator:
          • Syma Iqbal, MD
        • Contact:
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA Department of Medicine-Hematology/Oncology
        • Contact:
        • Principal Investigator:
          • Arun Singh, MD
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • Sylvester Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Jonathan C Trent, MD, PhD
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Recruiting
        • START Midwest
        • Contact:
        • Principal Investigator:
          • Sreenivasa Chandana, M.D., Ph.D.
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine - Siteman Cancer Center
        • Principal Investigator:
          • Mia Weiss, MD
        • Contact:
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center - Main Campus
        • Principal Investigator:
          • Ping Chi, MD, PhD
        • Contact:
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Taussig Cancer Center
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Contact:
          • Knight Cancer Institute Clinical Trials
          • Phone Number: 503-494-1080
          • Email: trials@ohsu.edu
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Recruiting
        • Fox Chase Cancer Center
        • Principal Investigator:
          • Margaret von Mehren, MD
        • Contact:
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Virginia Cancer Specialist, PC
        • Contact:
        • Principal Investigator:
          • Chao Yin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 (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:

  • Must not have received the following within the specified time periods prior to the first dose of study drug:

    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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation (Part 1, Module A)
Escalation Module A Part 1 inlexisertib combination closed on January 8, 2024, with no participants enrolled.
Drug: Inlexisertib
Oral Tablet Formulation
Other Names:
  • DCC-3116
Experimental: Expansion (Part 2, Module A)
Expansion Module A Part 2 inlexisertib combination closed on January 8, 2024, with no participants enrolled.
Drug: Inlexisertib
Oral Tablet Formulation
Other Names:
  • DCC-3116
Experimental: 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).
Drug: Ripretinib
Oral Tablet Formulation
Other Names:
  • QINLOCK, DCC-2618
Drug: Inlexisertib
Oral Tablet Formulation
Other Names:
  • DCC-3116
Experimental: 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).
Drug: Ripretinib
Oral Tablet Formulation
Other Names:
  • QINLOCK, DCC-2618
Drug: Inlexisertib
Oral Tablet Formulation
Other Names:
  • DCC-3116

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Approximately 24 months
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.
Approximately 24 months
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.
Approximately 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Approximately 48 months
OS is defined as the time from initiation of treatment until death.
Approximately 48 months
Duration of response (DoR)
Time Frame: Approximately 24 months
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.
Approximately 24 months
Disease Control Rate (DCR)
Time Frame: Approximately 24 months
The DCR is defined as the proportion of participants who achieve CR, PR, or stable disease (SD) per histology-specific consensus response criteria.
Approximately 24 months
Time to response
Time Frame: Approximately 24 months
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.
Approximately 24 months
Progression-free survival (PFS)
Time Frame: Approximately 24 months
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.
Approximately 24 months
Maximum observed concentration (Cmax)
Time Frame: Predose and up to 12 hours postdose
Measure the maximum observed concentration of inlexisertib combinations.
Predose and up to 12 hours postdose
Time to maximum observed concentration (Tmax)
Time Frame: Predose and up to 12 hours postdose
Measure the time to maximum plasma concentration of inlexisertib combinations.
Predose and up to 12 hours postdose
Minimum observed concentration (Cmin)
Time Frame: Predose and up to 12 hours postdose
Measure the minimum observed concentration of inlexisertib combinations.
Predose and up to 12 hours postdose
Area under the concentration-time curve (AUC)
Time Frame: Predose and up to 12 hours postdose
Measure the AUC of inlexisertib combinations.
Predose and up to 12 hours postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deciphera Pharmaceuticals, LLC

Collaborators

Pfizer

Investigators

  • Study Director: Clinical Team, Deciphera Pharmaceuticals, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2023

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

July 14, 2023

First Submitted That Met QC Criteria

July 14, 2023

First Posted (Actual)

July 24, 2023

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCC-3116-01-002
  • 2024-516476-15-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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