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

NCT05957367 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: DCC-3116-01-0022024-516476-15-00
• Study Type: interventional
• Target: 94
• Locations: 9 countries
• Sites: 25

Brief 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.

Conditions

GIST

Keywords

Advanced gastrointestinal stromal tumors; gastrointestinal stromal tumors; ripretinib

Outcome Measures

Primary Outcomes (3)

• Incidence of Adverse Events (Escalation Phase)

  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)

  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

• Objective response rate (ORR) (Expansion Phase)

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

  Approximately 24 months

Secondary Outcomes (9)

• Duration of response (DoR)

  Approximately 24 months

• Disease Control Rate (DCR)

  Approximately 24 months

• Time to response

  Approximately 24 months

• Progression-free survival (PFS)

  Approximately 24 months

• Overall Survival (OS)

  Approximately 48 months

Study Arms (4)

Dose Escalation (Part 1, Module A)

EXPERIMENTAL

Escalation Module A Part 1 inlexisertib combination closed on January 8, 2024, with no participants enrolled.

Drug: Inlexisertib

Expansion (Part 2, Module A)

EXPERIMENTAL

Expansion Module A Part 2 inlexisertib combination closed on January 8, 2024, with no participants enrolled.

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).

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).

Drug: Inlexisertib; Drug: Ripretinib

Interventions

Inlexisertib DRUG

Oral Tablet Formulation

Also known as: DCC-3116

Dose Escalation (Part 1, Module A); Dose Escalation (Part 1, Module B); Expansion (Part 2, Module A); Expansion (Part 2, Module B)

Ripretinib DRUG

Oral Tablet Formulation

Also known as: QINLOCK, DCC-2618

Dose Escalation (Part 1, Module B); Expansion (Part 2, Module B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Deciphera Pharmaceuticals, LLC: lead

Study Sites (25)

University of Southern California - Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

UCLA Department of Medicine-Hematology/Oncology

Los Angeles, California, 90095, United States

RECRUITING

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

RECRUITING

University of Massachusetts Worcester

Worcester, Massachusetts, 01655, United States

RECRUITING

START Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, 63110, United States

RECRUITING

Memorial Sloan Kettering Cancer Center - Main Campus

New York, New York, 10065, United States

RECRUITING

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

Virginia Cancer Specialist, PC

Fairfax, Virginia, 22031, United States

RECRUITING

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

Centre Oscar Lambret

Lille, 59020, France

RECRUITING

Hôpital Européen Georges Pompidou

Paris, 75015, France

RECRUITING

Universitatsklinikum Franfurt

Frankfurt, 60590, Germany

RECRUITING

Universitätsklinikum Eppendorf

Hamburg, 20246, Germany

RECRUITING

AOU Careggi - Padiglione 16 - Piano Terra - Ambulatori Oncologici - Ufficio Trial

Florence, 50134, Italy

RECRUITING

Istituto Europeo di Oncologia

Milan, 20141, Italy

RECRUITING

Antonie Van Leeuwenhoek Hospital

Amsterdam, 1066 CX, Netherlands

RECRUITING

Radboudumc

Nijmegen, 6525GA, Netherlands

RECRUITING

Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E.

Porto, 4200-072, Portugal

RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

RECRUITING

Hospital Universitario Clinico San Carlos

Madrid, 28040, Spain

RECRUITING

Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain

RECRUITING

Inselspital Universitätsklinikum Bern

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

ripretinib

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Clinical Team

  Deciphera Pharmaceuticals, LLC

  STUDY DIRECTOR

Central Study Contacts

Clinical Team

CONTACT

888-724-3274; Clinicaltrials@deciphera.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: July 24, 2023
• Study Start: September 28, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (11); CH (1); IT (2); FR (2); PT (1); ES (3); DK (1); NL (2); DE (2)