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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Deciphera Pharmaceuticals, LLC
Study ID
NCT05957367
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • GIST

Eligibility Criteria

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

Interventions

  • Inlexisertib — DRUG
    Oral Tablet Formulation
  • Ripretinib — DRUG
    Oral Tablet Formulation

Study Details

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.

Key Dates

Start date
Sep 28, 2023
Status verified
Apr 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2029

Study Design

Enrollment
94 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation (Part 1, Module A)
    Escalation Module A Part 1 inlexisertib combination closed on January 8, 2024, with no participants enrolled.
  • Experimental: Expansion (Part 2, Module A)
    Expansion Module A Part 2 inlexisertib combination closed on January 8, 2024, with no participants enrolled.
  • 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).
  • 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).

Primary Outcome Measure

Incidence of Adverse Events (Escalation Phase) [ Time Frame: Approximately 24 months ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
UCLA Department of Medicine-Hematology/OncologyLos AngelesCalifornia90095
Jacqueline Banuelos
[email protected]
310-869-7014
Arun Singh, MD (PRINCIPAL_INVESTIGATOR)
University of Southern California - Norris Comprehensive Cancer CenterLos AngelesCalifornia90033
Rabia Rehman
[email protected]
323-865-3000
Syma Iqbal, MD (PRINCIPAL_INVESTIGATOR)
Sylvester Comprehensive Cancer CenterMiamiFlorida33136
Nailet Bestard
[email protected]
305-243-8173
Jonathan C Trent, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of Massachusetts WorcesterWorcesterMassachusetts01655
Syliva Rollins
[email protected]
7744554454
START MidwestGrand RapidsMichigan49546
Julie Burns
[email protected]
616-954-5559
Sreenivasa Chandana, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)
Washington University School of Medicine - Siteman Cancer CenterSt LouisMissouri63110
Tori Tuma
[email protected]
314-747-9488
Mia Weiss, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer Center - Main CampusNew YorkNew York10065
Pragya Khadka
[email protected]
Melessa Hardayal
[email protected]
Ping Chi, MD, PhD (PRINCIPAL_INVESTIGATOR)
Cleveland Clinic Taussig Cancer CenterClevelandOhio44195
Cancer Answer
[email protected]
216-444-7923
Oregon Health & Science UniversityPortlandOregon97239
Knight Cancer Institute Clinical Trials
[email protected]
503-494-1080
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111
Refiola Memushi
[email protected]
(215)-728-3564
Margaret von Mehren, MD (PRINCIPAL_INVESTIGATOR)
Virginia Cancer Specialist, PCFairfaxVirginia22031
Anthony Jones
[email protected]
571-512-3202
Chao Yin, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
UCLA Department of Medicine-Hematology/Oncology· Los Angeles, CAUniversity of Southern California - Norris Comprehensive Cancer Center· Los Angeles, CASylvester Comprehensive Cancer Center· Miami, FLUniversity of Massachusetts Worcester· Worcester, MASTART Midwest· Grand Rapids, MIWashington University School of Medicine - Siteman Cancer Center· St Louis, MO

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