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En masterprotokol til evaluering af DCC-3009 i gastrointestinal stromal tumor (GIST)

9. november 2026 opdateret af: Deciphera Pharmaceuticals, LLC

En masterprotokol for multikohort, åbent, fase 1/2-studie af DCC-3009 i deltagere med gastrointestinal stromal tumor (GIST)

The purpose of this Phase 1/2 master protocol study is to evaluate if DCC-3009 is safe, tolerable and works effectively in the treatment of GIST. The study will use a modular approach with each module being defined according to therapy: DCC-3009 alone or DCC-3009 in combination with other anticancer therapies. Each module will be conducted in 3 parts: Part 1 (Dose Escalation), Part 2 (Dose Expansion), and Part 3 (Food Effect [FE] and Drug-Drug Interaction [DDI]). Participants will be treated in 28-day treatment cycles with an estimated duration of up to 2 years.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

155

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Arizona
    • California
      • La Jolla, California, Forenede Stater, 92093
        • Rekruttering
        • UC San Diego Moores Cancer Center
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • Rekruttering
        • University of Colorado Anschutz Medical Campus
        • Kontakt:
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32224
        • Rekruttering
        • Mayo Clinic Florida
        • Kontakt:
      • Miami, Florida, Forenede Stater, 33136
        • Rekruttering
        • University of Miami - Sylvester Comprehensive Cancer Center
        • Kontakt:
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Rekruttering
        • Dana Farber Cancer Institute
        • Kontakt:
          • Research Nurse
          • Telefonnummer: 617-632-5204
    • Michigan
    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
        • Rekruttering
        • Mayo Clinic Rochester
        • Kontakt:
    • New York
      • New York, New York, Forenede Stater, 10065
        • Rekruttering
        • Memorial Sloan Kettering Cancer Center
        • Kontakt:
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37232
        • Rekruttering
        • Vanderbilt University-Ingram Cancer Center
        • Kontakt:
          • Vanderbilt-Ingram Cancer Center Clinical Trials Office (CTO)
          • Telefonnummer: 800-811-8480
          • E-mail: CTIP@VUMC.ORG

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Key Inclusion Criteria:

Module A:

  • Have at least 1 measurable lesion as defined by mRECIST, v1.1
  • Have Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
  • Adequate organ function, bone marrow function, and electrolytes
  • All participants agree to comply with the contraception requirements
  • Have a life expectancy of more than 3 months

Module A Part 1 (Escalation) and Part 3 (FE and DDI):

-Any participant with histologically or cytologically confirmed advanced/unresectable or metastatic GIST with documented KIT or platelet-derived growth factor receptor alpha (PDGFRA) mutation, who has progressed on or was intolerant to at least 1 approved tyrosine kinase inhibitor (TKI) regimen in the advanced/metastatic setting

Module A Part 2 (Expansion):

-Any participant with histologically or cytologically confirmed advanced or metastatic GIST with documented KIT or PDGFRA mutation

Module A Part 3 (FE and DDI):

-Able to consume a high-fat meal

Key Exclusion Criteria:

  • Received systemic anticancer therapy or radiotherapy within 14 days prior to first dose of study drug
  • Prior or concurrent malignancy that requires treatment or is expected to require treatment for active cancer
  • Has known active central nervous system (CNS) metastases or an active primary CNS cancer
  • History or presence of clinically relevant cardiovascular abnormalities
  • Major surgery within 28 days of the first dose of study drug
  • Had systemic arterial thrombotic or embolic events within 6 months prior to the first dose of study drug
  • Had venous thrombotic events (e.g., deep vein thrombosis) or venous thrombotic embolic events (e.g., pulmonary embolism) within 1 month prior to the first dose of study drug
  • Known allergy or hypersensitivity to any component of the study drug
  • Malabsorption syndrome or other illness that could affect oral absorption
  • Any other clinically significant comorbidities

Module A Part 3 (FE and DDI):

  • Allergy or hypersensitivity to rabeprazole or any of its excipients
  • Unable or unwilling to adhere to overnight fasting of 10 hours

Other protocol-specified inclusion and exclusion criteria apply.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: DCC-3009 Module A

Participants will receive DCC-3009 in 28 day cycles in Module A Part 1 dose escalation, Part 2 dose expansion, and Part 3 FE and DDI. Participants in Part 3 will also receive rabeprazole.
Medicin: DCC-3009

Administered orally

Medicin: Rabeprazole

Administered orally (Part 3 only)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants with Dose-Limiting Toxicities (DLT) (Part 1 Escalation)
Tidsramme: Cycle 1 (28 Days)

DLTs assessed for each dose level.
Cycle 1 (28 Days)
Number of Participants with Treatment-emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs) (Part 1 Escalation)
Tidsramme: Cycle 1 (28 Days)
Cycle 1 (28 Days)
Number of Participants with Dose Reduction, Interruption, or Discontinuation of Study Drug Due to TEAEs (Part 1 Escalation)
Tidsramme: Cycle 1 (28 Days)
Cycle 1 (28 Days)
Objective Response Rate (ORR) (Part 2 Expansion)
Tidsramme: Baseline to Progressive Disease (PD), Death due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months)

ORR is the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) based on Modified Response Evaluation Criteria in Solid Tumors (mRECIST), v1.1.
Baseline to Progressive Disease (PD), Death due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months)
Pharmacokinetics (PK): Time to Maximum Observed Plasma Concentration (Tmax) (Part 3 FE and DDI)
Tidsramme: Estimated up to 24 months
Estimated up to 24 months
PK: Maximum Observed Plasma Drug Concentration (Cmax) (Part 3 FE and DDI)
Tidsramme: Estimated up to 24 months
Estimated up to 24 months
PK: Trough Plasma Concentration (Ctrough) (Part 3 FE and DDI)
Tidsramme: Estimated up to 24 months
Estimated up to 24 months
PK: Area Under the Plasma Concentration-time Curve (AUC) (Part 3 FE and DDI)
Tidsramme: Estimated up to 24 months
Estimated up to 24 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective Response Rate (ORR) (Part 1 Escalation and Part 3 FE and DDI)
Tidsramme: Baseline to Progressive Disease (PD), Death due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months)

ORR is the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) based on mRECIST, v1.1.
Baseline to Progressive Disease (PD), Death due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months)
Disease Control Rate (DCR)
Tidsramme: Weeks 16, 24, 32

DCR is the proportion of participants who achieve CR, PR, or stable disease at the specified time point per mRECIST, v1.1.
Weeks 16, 24, 32
Duration of Response (DOR)
Tidsramme: First Recorded CR or PR until PD or Death (Estimated up to 24 months)

DOR for participants with confirmed CR or confirmed PR based on mRECIST, v1.1, defined as the time interval from the time that the measurement criteria are first met for CR or PR (whichever is first recorded) until the first date that the disease progression is objectively documented or death, whichever occurs first.
First Recorded CR or PR until PD or Death (Estimated up to 24 months)
Time to Response (TTR)
Tidsramme: Baseline to First Recorded CR or PR (Estimated up to 24 months)

TTR for participants with confirmed CR or confirmed PR based on mRECIST, v1.1, defined as the time from initiation of treatment until the first assessment demonstrating CR or PR per mRECIST, v1.1.
Baseline to First Recorded CR or PR (Estimated up to 24 months)
Progression-Free Survival (PFS)
Tidsramme: Initiation of Treatment to PD or Death (Estimated up to 24 months)

PFS is the time from initiation of treatment until documented disease progression per mRECIST, v1.1, or death, whichever occurs first.
Initiation of Treatment to PD or Death (Estimated up to 24 months)
Overall Survival (OS)
Tidsramme: Initiation of Treatment to Death from Any Cause (Estimated up to 24 months)

OS is the time from initiation of treatment to the date of death from any cause.
Initiation of Treatment to Death from Any Cause (Estimated up to 24 months)
PK: Tmax (Part 1 Escalation and Part 2 Expansion)
Tidsramme: Estimated up to 24 months
Estimated up to 24 months
PK: Cmax (Part 1 Escalation and Part 2 Expansion)
Tidsramme: Estimated up to 24 months
Estimated up to 24 months
PK: Ctrough (Part 1 Escalation and Part 2 Expansion)
Tidsramme: Estimated up to 24 months
Estimated up to 24 months
PK: AUC (Part 1 Escalation and Part 2 Expansion)
Tidsramme: Estimated up to 24 months
Estimated up to 24 months
Number of Participants with TEAEs or SAEs (Part 2 Expansion and Part 3 FE and DDI)
Tidsramme: Estimated up to 24 months
Estimated up to 24 months
Number of Participants with Dose Reduction, Interruption, or Discontinuation of Study Drug Due to TEAEs (Part 2 Expansion and Part 3 FE and DDI)
Tidsramme: Estimated up to 24 months
Estimated up to 24 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Deciphera Pharmaceuticals, LLC

Efterforskere

  • Studieleder: Clinical Team, Deciphera Pharmaceuticals, LLC

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. december 2024

Primær færdiggørelse (Anslået)

1. maj 2028

Studieafslutning (Anslået)

1. maj 2028

Datoer for studieregistrering

Først indsendt

4. oktober 2024

Først indsendt, der opfyldte QC-kriterier

4. oktober 2024

Først opslået (Faktiske)

8. oktober 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DCC-3009-01-001
  • 2026-525379-20-00 (Ctis)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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