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Un estudio de Fase 1/2 de TRI-611 en NSCLC ALK-positivo

4 de noviembre de 2026 actualizado por: TRIANA Biomedicines, Inc.

Un estudio de fase 1/2 de escalada de dosis y expansión de TRI-611, un degradador molecular oral de ALK, en participantes con NSCLC avanzado ALK-positivo

The goal of this clinical trial is to learn about the safety and recommended dose of TRI-611 when administered to adults with ALK-positive non-small cell lung cancer (NSCLC). The trial will also evaluate the antitumor activity of TRI-611 in adults with ALK-positive NSCLC.

The study will be conducted in two parts. The first part will examine different doses of TRI-611. The second part will look at how well TRI-611 works on ALK-positive NSCLC when administered to three groups of participants that differ based on what type of prior therapy they have received.

In this study participants will:

  • Take TRI-611 on a continued basis, provided it is well-tolerated, for as long as their disease is not progressing
  • Visit the clinic approximately seven times in the first 3 months and then just once at the start of each 28-day cycle thereafter
  • Keep a diary of each time they take the study medication

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

This is a Phase 1/2 dose escalation and dose expansion study designed to evaluate the safety and tolerability of TRI-611, identify the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in participants with ALK-positive NSCLC.

Part 1 of the study consists of a dose escalation to determine the MTD and/or recommended dose(s) of TRI-611 for further exploration in two backfill cohorts.

Following completion of Part 1 of the study, Part 2 of the study will be initiated. The second part of the study is comprised of three cohorts (M1, M2, M3) of participants differentiated based on their previous treatment with ALK TKIs (tyrosine kinase inhibitors). During this part of the study the antitumor activity of TRI-611 will be further explored. See eligibility criteria for more details.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

160

Fase

  • Fase 2
  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2000
        • Reclutamiento
        • Royal North Shore Hospital
        • Investigador principal:
          • Malinda Itchins, MD
      • Westmead, New South Wales, Australia, 2145
        • Reclutamiento
        • Westmead Hospital
        • Investigador principal:
          • Adnan Nagrial, MD
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Reclutamiento
        • Peter MacCallum Cancer Centre
        • Investigador principal:
          • Ben Solomon, MD
  • Estados Unidos
    • California
      • San Francisco, California, Estados Unidos, 94158
        • Reclutamiento
        • UCSF
        • Investigador principal:
          • Collin Blakely, MD
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
        • Reclutamiento
        • University of Colorado Cancer Center
        • Investigador principal:
          • Kyle Concannon, MD
        • Contacto:
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02114
        • Reclutamiento
        • Massachusetts General Hospital
        • Investigador principal:
          • Jessica Lin, MD
        • Contacto:
          • Jessica Lin, MD
          • Número de teléfono: 617-724-4000
          • Correo electrónico: jjlin1@mgb.org
      • Boston, Massachusetts, Estados Unidos, 02215
        • Reclutamiento
        • Dana Farber Cancer Center
        • Investigador principal:
          • Alice Shaw, MD
        • Contacto:
    • Missouri
      • St Louis, Missouri, Estados Unidos, 63130
        • Reclutamiento
        • Washington University Medical Center
        • Investigador principal:
          • Saiama Waqar, MD
        • Contacto:
    • New York
      • New York, New York, Estados Unidos, 10065
        • Reclutamiento
        • Memorial Sloan-Kettering Cancer Center
        • Investigador principal:
          • Alexander Drilon, MD
        • Contacto:
          • Memorial Sloan Kettering Cancer Center
          • Número de teléfono: 646-608-3758
    • North Carolina
      • Durham, North Carolina, Estados Unidos, 27710-2000
        • Reclutamiento
        • Duke University
        • Investigador principal:
          • Thomas Stinchcombe, MD
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45221
        • Reclutamiento
        • University of Cincinnati Cancer Center
        • Investigador principal:
          • Jennifer Leddon, MD
      • Maumee, Ohio, Estados Unidos, 43537
        • Reclutamiento
        • Taylor Cancer Research Center
        • Investigador principal:
          • John Nemunaitis, MD
        • Contacto:
          • Stephanie Ambrose
          • Número de teléfono: 567-402-4500
          • Correo electrónico: sambrose@tcrcpt.org
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Estados Unidos, 15213
        • Reclutamiento
        • UPMC Hillman Cancer Center
        • Investigador principal:
          • Lisa Villaruz, MD
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37203
        • Reclutamiento
        • SCRI Oncology Partners
        • Investigador principal:
          • Melissa Johnson, MD
        • Contacto:
    • Texas
      • Houston, Texas, Estados Unidos, 77030
        • Reclutamiento
        • Oncology Consultants Research (P1 Trials)
        • Investigador principal:
          • Julio Peguero, MD
        • Contacto:
    • Utah
      • West Valley City, Utah, Estados Unidos, 84119
        • Reclutamiento
        • START-Mountain Region
        • Investigador principal:
          • José Pacheco, MD
        • Contacto:
    • Virginia
      • Fairfax, Virginia, Estados Unidos, 22031
        • Reclutamiento
        • NEXT Virginia
        • Investigador principal:
          • Alexander Spira, MD
  • Francia
      • Lyon, Francia, 69008
        • Reclutamiento
        • Centre Léon Bérard
        • Investigador principal:
          • Aurelie Swalduz, MD
      • Villejuif, Francia, 94800
        • Reclutamiento
        • Gustave Roussy Institute
        • Investigador principal:
          • Anas Gazzah, MD
  • Reino Unido
      • Sutton, Reino Unido, SM2 5PT
        • Reclutamiento
        • The Royal Marsden NHS Foundation
        • Investigador principal:
          • Anna Minchom, MD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Pathologically confirmed diagnosis of ALK-positive non-small cell lung cancer (NSCLC)
  • Measurable disease per RECIST v1.1
  • Adequate bone marrow reserve and organ function
  • Part 1: prior treatment with 2 to 3 ALK TKIs [in US only: '2 or more ALK TKIs'], prior treatment with lorlatinib is required but must not have been in the first line
  • Part 2 Cohort M1: prior treatment with 2 to 3 ALK TKIs, prior treatment with lorlatinib is required but must not have been in the first line, prior treatment with neladalkib is excluded
  • Part 2 Cohort M2: prior treatment with more than 3 ALK TKIs, prior treatment with lorlatinib and neladalkib is required but neither may have been in the first line
  • Part 2 Cohort M3: participants without prior ALK TKI treatment

Exclusion Criteria:

  • Participant's cancer has any additional driver alterations known to be a mechanism of resistance to ALK TKIs
  • For participants with central nervous system (CNS) metastases or spinal cord compression, they must not be associated with progressive neurological symptoms or require increasing doses of corticosteroids to control the CNS disease
  • Ongoing treatment with another anticancer treatment or investigational agent
  • Known allergy/hypersensitivity to TRI-611 or any of its ingredients
  • Major surgery within 4 weeks of receiving the first dose of TRI-611

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación Secuencial
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Part 1: Dose Escalation and Backfill

Prior treatment with 2 to 3 ALK TKIs, prior treatment with lorlatinib is required but must not have been in the first line
Droga: TRI-611

oral ALK molecular glue degrader
Experimental: Part 2: Cohort M1

Prior treatment with ALK TKIs, including lorlatinib. Prior treatment with neladalkib is excluded
Droga: TRI-611

oral ALK molecular glue degrader
Experimental: Part 2: Cohort M2

Prior treatment with ALK TKIs, including lorlatinib. Prior treatment with neladalkib is required
Droga: TRI-611

oral ALK molecular glue degrader
Experimental: Part 2: Cohort M3

Participants without prior ALK TKI treatment
Droga: TRI-611

oral ALK molecular glue degrader

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Part 1: Treatment emergent adverse events
Periodo de tiempo: Within 28 days of the first TRI-611 dose

Treatment emergent adverse events (TEAEs)
Within 28 days of the first TRI-611 dose
Part 2: Objective response rate (ORR)
Periodo de tiempo: Approximately 16 weeks after the last participant dosed in Part 2

Determine the objective response rate (ORR) based on RECIST v1.1
Approximately 16 weeks after the last participant dosed in Part 2
Part 2: Depth of response (DofR)
Periodo de tiempo: Approximately 16 weeks after the last participant dosed in Part 2

Defined as the greatest percentage reduction in the sum of diameters of target lesions from baseline
Approximately 16 weeks after the last participant dosed in Part 2

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Part 1: Half-life (t1/2) of TRI-611
Periodo de tiempo: Pre-dose and up to 24 hours post-dose

Determine the t1/2 of TRI-611
Pre-dose and up to 24 hours post-dose
Part 1: Area under the curve (AUC) of TRI-611
Periodo de tiempo: Pre-dose and up to 24 hours post-dose

Determine the AUC of TRI-611
Pre-dose and up to 24 hours post-dose
Part 1: Maximum plasma concentration (Cmax) of TRI-611
Periodo de tiempo: Pre-dose and up to 24 hours post-dose

Determine the Cmax of TRI-611
Pre-dose and up to 24 hours post-dose
Part 1: Minimum plasma concentration (Cmin) of TRI-611
Periodo de tiempo: Pre-dose and up to 24 hours post-dose

Determine the Cmin of TRI-611
Pre-dose and up to 24 hours post-dose
Part 1: ORR
Periodo de tiempo: Approximately 16 weeks after the last participant dosed in Part 1

Determine the ORR based on RECIST v1.1
Approximately 16 weeks after the last participant dosed in Part 1
Part 1: DofR
Periodo de tiempo: Approximately 16 weeks after the last participant dosed in Part 1

Defined as the greatest percentage reduction in the sum of diameters of target lesions from baseline
Approximately 16 weeks after the last participant dosed in Part 1
Parts 1&2: Duration of response (DOR)
Periodo de tiempo: Approximately 5 years after the last participant is dosed with TRI-611

Determine the DOR based on RECIST v1.1
Approximately 5 years after the last participant is dosed with TRI-611
Parts 1&2: Disease control rate (DCR)
Periodo de tiempo: Approximately 16 weeks after the last participant dosed

Defined as the number and percentage of participants who have achieved a response or stable disease based on RECIST v1.1
Approximately 16 weeks after the last participant dosed
Parts 1&2: Clinical Benefit Rate (CBR)
Periodo de tiempo: Approximately 9 months after the last participant is dosed

Defined as the number and percentage of participants who have achieved a response or stable disease based on RECIST v1.1 maintained for a minimum of 6 months
Approximately 9 months after the last participant is dosed
Parts 1&2: Progression-free survival (PFS)
Periodo de tiempo: Approximately 5 years after the last participant is dosed with TRI-611

Determine PFS based on RECIST v1.1
Approximately 5 years after the last participant is dosed with TRI-611
Parts 1&2: Overall survival (OS)
Periodo de tiempo: Approximately 5 years after the last participant is dosed with TRI-611

Determine OS based on RECIST v1.1
Approximately 5 years after the last participant is dosed with TRI-611
Parts 1&2: Central Nervous System (CNS) objective response rate (ORR)
Periodo de tiempo: Approximately 16 weeks after the last participant dosed

Determine CNS ORR based on modified RECIST (mRECIST v1.1) in participants with CNS metastasis at baseline
Approximately 16 weeks after the last participant dosed
Parts 1&2: CNS duration of response (DOR)
Periodo de tiempo: Approximately 5 years after the last participant is dosed with TRI-611

Determine CNS DOR based on mRECIST v1.1 in participants with CNS metastasis at baseline
Approximately 5 years after the last participant is dosed with TRI-611
Parts 1&2: Time to intracranial progression (TTP)
Periodo de tiempo: Approximately 5 years after the last participant is dosed with TRI-611

Defined as the time to the date of the first documentation of objective progression of intracranial disease
Approximately 5 years after the last participant is dosed with TRI-611
Part 1: Profile changes in tumor ALK-fusion protein levels
Periodo de tiempo: Approximately 14 days after the last dose of participants in Part 1 that have consented to on-treatment biopsies

Assessing treatment-induced modulation of ALK expression only in participants consenting to on-treatment biopsies
Approximately 14 days after the last dose of participants in Part 1 that have consented to on-treatment biopsies

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

TRIANA Biomedicines, Inc.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

11 de marzo de 2026

Finalización primaria (Estimado)

31 de mayo de 2029

Finalización del estudio (Estimado)

30 de enero de 2034

Fechas de registro del estudio

Enviado por primera vez

11 de marzo de 2026

Primero enviado que cumplió con los criterios de control de calidad

19 de marzo de 2026

Publicado por primera vez (Actual)

24 de marzo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

4 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • TRI-611-101

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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