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RecruitingInterventionalPhase 1/Phase 2

A Master Protocol for the Multi-Cohort, Phase 1/2 Study of DCC-3116 in Combination With Anticancer Therapies in Participants With Advanced Malignancies

NCT ID: NCT05957367Sponsor: Deciphera Pharmaceuticals, LLCLast updated: 2026-06-02

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.

Arms & interventions

  • DrugInlexisertib

    Oral Tablet Formulation

  • DrugRipretinib

    Oral Tablet Formulation

Outcome measures

Primary

  • Incidence of Adverse Events (Escalation Phase)

    Identify the observed adverse events and serious adverse events associated with inlexisertib in combination with other anticancer therapies.

    Time frame: 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.

    Time frame: Approximately 18 months

  • Objective response rate (ORR) (Expansion Phase)

    Proportion of participants who achieve CR or PR per histology-specific consensus response criteria.

    Time frame: Approximately 24 months

Secondary

  • 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

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (11)

University of Southern California - Norris Comprehensive Cancer Center

Los Angeles, California, 90033

Recruiting
Syma Iqbal, MD · Principal Investigator

UCLA Department of Medicine-Hematology/Oncology

Los Angeles, California, 90095

Recruiting
Jacqueline Banuelos · Contact
Arun Singh, MD · Principal Investigator

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136

Recruiting
Nailet Bestard · Contact
Jonathan C Trent, MD, PhD · Principal Investigator

University of Massachusetts Worcester

Worcester, Massachusetts, 01655

Recruiting
Syliva Rollins · Contact

START Midwest

Grand Rapids, Michigan, 49546

Recruiting
Sreenivasa Chandana, M.D., Ph.D. · Principal Investigator

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, 63110

Recruiting
Tori Tuma · Contact
Mia Weiss, MD · Principal Investigator

Memorial Sloan Kettering Cancer Center - Main Campus

New York, New York, 10065

Recruiting
Pragya Khadka · Contact
Melessa Hardayal · Contact
Ping Chi, MD, PhD · Principal Investigator

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195

Recruiting
Cancer Answer · Contact

Oregon Health & Science University

Portland, Oregon, 97239

Recruiting
Knight Cancer Institute Clinical Trials · Contact

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

Recruiting
Refiola Memushi · Contact
Margaret von Mehren, MD · Principal Investigator

Virginia Cancer Specialist, PC

Fairfax, Virginia, 22031

Recruiting
Chao Yin, MD · Principal Investigator