Study of Inlexisertib (DCC-3116) in Participants With RAS/MAPK Pathway Mutant Solid Tumors

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Deciphera Pharmaceuticals, LLC
Study ID
NCT04892017
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Inlexisertib — DRUG
    Oral Tablet Formulation
  • Trametinib — DRUG
    Oral Tablet Formulation
  • Binimetinib — DRUG
    Oral Tablet Formulation
  • Sotorasib — DRUG
    Oral Tablet Formulation

Study Details

This is a multicenter, open label, first in human (FIH) study of inlexisertib as monotherapy, and in combination with trametinib, binimetinib, or sotorasib in participants with advanced or metastatic solid tumors with RAS/MAPK pathway mutation. The study consists of 2 parts, a dose-escalation phase, and an expansion phase.

Key Dates

Start date
Jun 15, 2021
Status verified
Apr 2026
Primary completion
Mar 30, 2026
Completion
Mar 30, 2026

Study Design

Enrollment
91 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation (Part 1, Cohort A Monotherapy)
    Inlexisertib tablets in escalating dose cohorts given orally twice daily (BID) in 28-day cycles as monotherapy (single agent). If no DLT in 3 participants or 1 DLT/6 participants is observed, dose escalation may continue to the next planned dose cohort.
  • Experimental: Dose Escalation (Part 1, Cohort B Combination)
    Upon determination of the RP2D/MTD single agent, inlexisertib will be dosed in combination with trametinib. Escalation Cohort B combination closed on January 8, 2024.
  • Experimental: Dose Escalation (Part 1, Cohort C Combination)
    Upon determination of the RP2D/MTD single agent, inlexisertib will be dosed in combination with binimetinib. Escalation Cohort C combination closed on January 8, 2024.
  • Experimental: Dose Escalation (Part 1, Cohort D Combination)
    Upon determination of the RP2D/MTD single agent, inlexisertib will be dosed in combination with sotorasib.
  • Experimental: Expansion Cohorts 1, 2, 3 and 4 (Part 2)
    Expansion Cohorts 1, 2, 3 and 4 inlexisertib combinations will not open for enrollment.
  • Experimental: Expansion Cohort 5 (Part 2)
    Inlexisertib tablets orally given in combination with sotorasib in 28-day cycles to evaluate safety and preliminary efficacy of participants with NSCLC (with a documented mutation in KRAS G12C). Trial terminated prior to start of Part 2.

Primary Outcome Measure

Incidence of Adverse Events [ Time Frame: Approximately 24 months ]

Locations (10)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-
Washington University Siteman Cancer CenterSt LouisMissouri63108-
Rutgers Cancer InstituteNew BrunswickNew Jersey08901-
Laura & Isaac Perlmutter Cancer Center at NYU Langone HealthNew YorkNew York10016-
Oregon Health and Science UniversityPortlandOregon97239-
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104-
NEXT OncologyAustinTexas78758-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
NEXT OncologySan AntonioTexas78229-
University of Wisconsin Clinical Science CenterMadisonWisconsin53792-

Find similar trials in Boston, MA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Massachusetts General Hospital· Boston, MAWashington University Siteman Cancer Center· St Louis, MORutgers Cancer Institute· New Brunswick, NJLaura & Isaac Perlmutter Cancer Center at NYU Langone Health· New York, NYOregon Health and Science University· Portland, ORHospital of the University of Pennsylvania· Philadelphia, PA

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