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Study of [177Lu]Lu-DWJ155 and [68Ga]Ga-DWJ155 in Patients With Solid Tumors

26 de agosto de 2026 actualizado por: Novartis Pharmaceuticals

A Phase I Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-DWJ155 and Safety and Imaging Properties of [68Ga]Ga-DWJ155 in Patients With Solid Tumors

The purpose of this phase I study is to evaluate the safety, tolerability, dosimetry, and preliminary anti-tumor activity of [177Lu]Lu-DWJ155 and the safety and imaging properties of [68Ga]Ga-DWJ155 in patients with histologically or cytologically confirmed advanced HER2+, HR+/HER2-negative, or triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), HER2-3+ or 2+ (ISH positive or negative) gastric/gastroesophageal junction (GEJ) cancer, and bladder cancer.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

The study will be done in two parts. The first part is called "escalation" and the second part is called "expansion". In both parts of the study, patients will initially be imaged with a [68Ga]Ga-DWJ155 positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) scan. In the escalation part, different doses of [177Lu]Lu-DWJ155 will then be tested to identify recommended dose(s) (RD(s)) for further evaluation. The expansion part of the study will examine the safety and preliminary efficacy of [177Lu]Lu-DWJ155 at the RD(s) determined during the escalation part.

In both parts, there will be a safety follow-up period after the last [177Lu]Lu-DWJ155 administration.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

156

Fase

  • 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

Copia de seguridad de contactos de estudio

  • Nombre: Novartis Pharmaceuticals
  • Número de teléfono: +41613241111

Ubicaciones de estudio

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Reclutamiento
        • Novartis Investigative Site
  • Canadá
    • Quebec
      • Montreal, Quebec, Canadá, H4A 3J1
        • Reclutamiento
        • Novartis Investigative Site
      • Montreal, Quebec, Canadá, H2X 0A9
        • Reclutamiento
        • Novartis Investigative Site
  • Estados Unidos
    • Nebraska
      • Omaha, Nebraska, Estados Unidos, 68130
        • Reclutamiento
        • Nebraska Cancer Specialists
        • Investigador principal:
          • Ralph Hauke
        • Contacto:
  • Japón
    • Chiba
      • Kashiwa, Chiba, Japón, 2778577
        • Reclutamiento
        • Novartis Investigative Site

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

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Male or female patients age ≥ 18 years.
  • Patients with one of the following histologically or cytologically confirmed and documented malignancies who have progressed on or been intolerant to standard of care therapy, and are not considered appropriate for any standard therapy with proven benefit, in the investigator's judgment:

  • Dose Escalation:

    • Advanced HER2+ breast cancer with disease progression after at least two prior lines of systemic therapy in the advanced setting
    • Advanced HR+/HER2-low breast cancer with disease progression after prior therapy in the advanced setting
    • Advanced NSCLC without actionable genetic alterations (AGAs) with disease progression after prior therapy in the advanced setting
    • Advanced NSCLC with AGAs who have received prior treatment
    • Measurable disease as determined by RECIST version 1.1.

  • Dose Expansion:

    • Advanced HER2+ breast cancer with disease progression after at least two prior lines of systemic therapy in the advanced setting
    • Advanced HR+/HER2-low breast cancer with disease progression after prior therapy in the advanced setting
    • Advanced HR+/HER2 0 breast cancer with disease progression after prior therapy in the advanced setting
    • Advanced HR-/HER2-low breast cancer with disease progression after prior therapy in the advanced setting
    • Advanced HR-/HER2 0 breast cancer with disease progression after prior therapy in the advanced setting
    • Advanced NSCLC with AGAs, who have received prior treatment
    • Advanced NSCLC without known AGAs who have received prior treatment.
    • Advanced gastric/GEJ cancer with HER2 IHC 3+ or 2+ (ISH + or -), following disease progression after prior therapy in the advanced setting
    • Advanced bladder cancer following disease progression after prior therapy in the advanced setting
    • Measurable disease as determined by RECIST version 1.1.

Exclusion Criteria:

  • Out-of-range laboratory values defined as:

    • Creatinine clearance < 60 mL/min (calculated using CKD-EPI 2021 formula, or measured)
    • Total bilirubin > 1.5 x ULN (except for patients with Gilbert's syndrome who are excluded if total bilirubin >3.0 x ULN) or direct bilirubin > 1.5 x ULN
    • Alanine aminotransferase (ALT) > 3 x ULN, except for patients with tumor involvement of the liver who are excluded if ALT > 5 x ULN
    • Aspartate aminotransferase (AST) > 3 x ULN, except for patients with tumor involvement of the liver who are excluded if AST > 5 x ULN
    • Lipase > 1.5 x ULN
    • Absolute neutrophil count (ANC) < 1.5 x 109/L
    • Hemoglobin < 9 g/dL
    • Platelet count < 100 x 109/L
  • Initiation of hematopoietic colony stimulating factors, thrombopoietin mimetics, or erythroid stimulating agents initiated ≤ 2 weeks prior to imaging agent administration.
  • Use of transfusion support ≤4 weeks prior to imaging agent administration.
  • Impaired cardiac function or clinically significant cardiac disease.
  • Unmanageable urinary tract obstruction or urinary incontinence.
  • Any serious uncontrolled infection (acute or chronic).
  • Pregnant or breastfeeding women.

  • Treatment with any of the following anti-cancer therapies prior to imaging agent administration within the stated timeframes:

    • Prior treatment with any therapeutic radiopharmaceutical
    • < 10 half-lives for any imaging radiopharmaceutical
    • ≤ 4 weeks for external beam radiation therapy (EBRT) or brachytherapy
    • ≤ 6 months for lung-directed external beam radiotherapy
  • Patients with non-tumor uptake of [68Ga]Ga-DWJ155 in tissues or organs that, in the opinion of the investigator, increases the risk associated with [177Lu]Lu-DWJ155 treatment.

Other protocol-defined inclusion/exclusion criteria may apply.

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: Dose Escalation
Patients will receive [68Ga]Ga-DWJ155 and, if eligible, [177Lu]Lu-DWJ155. In this part, multiple dose levels of [177Lu]Lu-DWJ155 will be evaluated.
Prueba de diagnóstico: [68Ga]Ga-DWJ155
Radioligand imaging agent
Otros nombres:
  • FKL480
Droga: [177Lu]Lu-DWJ155
Radioligand therapy
Otros nombres:
  • FML539
Experimental: Dose Expansion
Patients will receive [68Ga]Ga-DWJ155 and, if eligible, [177Lu]Lu-DWJ155 at the recommended dose established during the dose escalation part.
Prueba de diagnóstico: [68Ga]Ga-DWJ155
Radioligand imaging agent
Otros nombres:
  • FKL480
Droga: [177Lu]Lu-DWJ155
Radioligand therapy
Otros nombres:
  • FML539

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) of [177Lu]Lu-DWJ155
Periodo de tiempo: Up to approximately 53 months
Incidence and severity of AEs and SAEs, including changes in laboratory values, vital signs, echocardiograms (ECGs), and imaging assessments qualifying and reported as AEs.
Up to approximately 53 months
Incidence of dose-limiting toxicities (DLTs) of [177Lu]Lu-DWJ155
Periodo de tiempo: Up to 6 weeks
A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness/injury or concomitant medications that occurs within the first treatment cycle. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
Up to 6 weeks
Frequency of dose interruptions and reductions [177Lu]Lu-DWJ155
Periodo de tiempo: 11 months
Number of participants with dose interruptions and/or reductions to assess the tolerability.
11 months
Dose intensity [177Lu]Lu-DWJ155
Periodo de tiempo: 11 months
Dose intensity defined as the ratio of actual cumulative dose received and actual duration of exposure
11 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Response Rate (ORR) per RECIST v1.1
Periodo de tiempo: Up to approximately 53 months
ORR is defined as the proportion of patients with a best overall response (BOR) of complete response (CR) or partial response (PR) as per local review and according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Up to approximately 53 months
Disease Control Rate (DCR) per RECIST v1.1
Periodo de tiempo: Up to approximately 53 months
DCR is defined as the proportion of patients with a BOR of CR, PR, or stable disease (SD) as per local review and according to RECIST v1.1.
Up to approximately 53 months
Duration of Response (DOR) per RECIST v1.1
Periodo de tiempo: Up to approximately 53 months
DOR is the time between the first documented response (CR or PR) and the date of progression as per local review and according to RECIST v1.1, or death due to any cause.
Up to approximately 53 months
Progression-Free Survival (PFS) per RECIST v1.1
Periodo de tiempo: Up to approximately 53 months
PFS is defined as the time from the date of start of treatment to the date of the first documented progression as per local review and according to RECIST v1.1 or death due to any cause.
Up to approximately 53 months
Area under the concentration-time curve (AUC) of [177Lu]Lu-DWJ155
Periodo de tiempo: From pre-dose up to 168 hours after the end of the infusion on Day 1
The pharmacokinetic (PK) analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. AUC will be determined by non-compartmental methods.
From pre-dose up to 168 hours after the end of the infusion on Day 1
Systemic clearance (CL) of [177Lu]Lu-DWJ155
Periodo de tiempo: From pre-dose up to 168 hours after the end of the infusion on Day 1
The PK analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. CL will be determined by non-compartmental methods.
From pre-dose up to 168 hours after the end of the infusion on Day 1
Maximum observed concentration (Cmax) of [177Lu]Lu-DWJ155
Periodo de tiempo: From pre-dose up to 168 hours after the end of the infusion on Day 1
The PK analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. Cmax will be determined by non-compartmental methods.
From pre-dose up to 168 hours after the end of the infusion on Day 1
Volume of distribution during the terminal phase (Vz) of [177Lu]Lu-DWJ155
Periodo de tiempo: From pre-dose up to 168 hours after the end of the infusion on Day 1
The PK analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. Vz will be determined by non-compartmental methods.
From pre-dose up to 168 hours after the end of the infusion on Day 1
Terminal half-life (T1/2) of [177Lu]Lu-DWJ155
Periodo de tiempo: From pre-dose up to 168 hours after the end of the infusion on Day 1
The PK analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. T1/2 will be determined by non-compartmental methods.
From pre-dose up to 168 hours after the end of the infusion on Day 1
Urinary excretion of [177Lu]Lu-DWJ155
Periodo de tiempo: From pre-dose up to 72 hours after the end of the infusion on Day 1
The PK analysis will be performed based on decay-corrected urine radioactivity concentration data converted to mass units. Urinary excretion will be derived based on the percentage of injected dose excreted in urine in each collection interval and overall.
From pre-dose up to 72 hours after the end of the infusion on Day 1
Renal clearance (CLr) of [177Lu]Lu-DWJ155
Periodo de tiempo: From pre-dose up to 72 hours after the end of the infusion on Day 1
The PK analysis will be performed based on decay-corrected blood and urine radioactivity concentration data converted to mass units. CLr will be determined by non-compartmental methods.
From pre-dose up to 72 hours after the end of the infusion on Day 1
Absorbed radiation dose in selected organs, tumor lesions and total body of [177Lu]Lu-DWJ155
Periodo de tiempo: Up to 168 hours after the end of the infusion on Day 1
Single Photon Emission Computed Tomography/Computed Tomography (SPECT/CT) images will be acquired to assess total body, organ and tumor lesion dosimetry.
Up to 168 hours after the end of the infusion on Day 1
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) of [68Ga]Ga-DWJ155:
Periodo de tiempo: Up to 3 days
Incidence and severity of AEs and SAEs, including changes in laboratory values, vital signs, echocardiograms (ECGs), and cardiac imaging qualifying and reported as AEs.
Up to 3 days
Standard uptake values (SUVs) in normal tissues and selected tumor lesions of [68Ga]Ga-DWJ155
Periodo de tiempo: Up to approximately 1.5 hours after the end of infusion
68Ga-DWJ155 positron emission tomography/computed tomography (PET/CT) or positron emission tomography/magnetic resonance imaging (PET/MRI) imaging assessments will be performed to derive SUVs in normal tissues and selected tumor lesions.
Up to approximately 1.5 hours after the end of infusion

Colaboradores e Investigadores

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

Patrocinador

Novartis Pharmaceuticals

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)

16 de junio de 2026

Finalización primaria (Estimado)

24 de mayo de 2032

Finalización del estudio (Estimado)

24 de mayo de 2032

Fechas de registro del estudio

Enviado por primera vez

15 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

15 de junio de 2026

Publicado por primera vez (Actual)

22 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de agosto de 2026

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

26 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CFML539A12101
  • 2024-518348-19 (Otro identificador: EU CTIS)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

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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