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Estudio de [212Pb]Pb-DOTAM-MAM279 en pacientes con cáncer de pulmón de células pequeñas y otros tumores sólidos que expresan DLL3

20 de octubre de 2026 actualizado por: Molecular Partners AG

Un Estudio de Fase 1/2a para Evaluar la Seguridad, Tolerabilidad y Eficacia de [212Pb]Pb-DOTAM-MAM279 en Pacientes con Cáncer de Pulmón de Células Pequeñas y Otros Tumores Sólidos que Expresan DLL3

The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of [212Pb]Pb-MP0712, in patients aged ≥18 years with Small Cell Lung Cancer and other locally advanced or metastatic DLL3 positive tumors.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

This is a phase I/IIa, open-label, multi-center study to evaluate the safety, tolerability, dosimetry, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of [212Pb]Pb-MP0712 in patients with SCLC and other advanced DLL3-expressing solid tumors. The study consists of a dose escalation part, followed by a dose expansion part. Once the recommended radioactive dose(s) [212Pb]Pb-MP0712 for further clinical evaluation are determined, the dose expansion part will further characterize the safety, tolerability, and preliminary anti-tumor activity of [212Pb]Pb-MP0712. The study will enable evaluation of the safety, dosimetry, PK, and imaging properties of [203Pb]Pb-MP0712.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

138

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

  • Estados Unidos
    • Florida
      • Tampa, Florida, Estados Unidos, 33612
        • Reclutamiento
        • Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30322
        • Reclutamiento
        • Emory University Hospital
        • Contacto:
          • Ryan Hanula
          • Número de teléfono: 404-778-5141
          • Correo electrónico: rhanula@emory.edu
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60637
        • Reclutamiento
        • University of Chicago
    • Maryland
      • Glen Burnie, Maryland, Estados Unidos, 21061
        • Reclutamiento
        • United Theranostics
        • Contacto:
    • Nebraska
      • Omaha, Nebraska, Estados Unidos, 68130
    • New Jersey
      • Princeton, New Jersey, Estados Unidos, 08540
        • Reclutamiento
        • United Theranostics
        • Contacto:
    • Ohio
      • Cleveland, Ohio, Estados Unidos, 44106
        • Reclutamiento
        • University Hospitals Cleveland Medical Center
        • Contacto:
    • Texas
      • Houston, Texas, Estados Unidos, 77030
        • Reclutamiento
        • The University of Texas MD Anderson Cancer Center

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

Key Inclusion Criteria:

  • Age ≥ 18 years old

  • Histologically or cytologically confirmed: I. advanced extensive or limited SCLC or LC NECs of the lung

    • SCLC (extensive stage, or limited stage) patients with progression or recurrence following at least two prior line of systemic platinum based therapy and immunotherapy or are not suitable or tolerating the standard of care treatment as second line of systemic therapy, or
    • LC NEC of the lung patients with progression or recurrence following at least one prior line of systemic therapy, or II. epNECs with progression or recurrence following at least one prior line of systemic therapy:
    • Gastroenteropancreatic NECs (GEPNEC), or
    • Cervical NECs, or
    • Bladder NECs, or
    • other epNECs with previously confirmed DLL3 expression by IHC.
    • Patients with prior DLL3-targeted therapy are allowed.

  • For epNECs in Part 1 and Part 2 and SCLC or LC NECs of the lung in Part 2: DLL3-positivity by [203Pb]Pb-DOTAM-MAM279 SPECT/CT

  • Radiographically documented disease progression or recurrence during or after the last line of systemic treatment therapy

  • At least one measurable disease per RECIST v1.1.

  • Adequate bone marrow reserve and organ function as demonstrated by complete blood count, and biochemistry in blood and urine at Screening

  • Adequate blood counts: Hemoglobin ≥9 g/dL; Absolute neutrophil count (ANC) ≥1.5 × 10^9/L; Platelets ≥100 × 10^9/L; White blood cells (WBC) ≥2.5 x 10^9/L;

  • Adequate hepatic function

  • Adequate renal function: Calculated glomerular filtration rate (GFR) >60mL/min (using Cockroft-Gault formula).

  • Patients with known central nervous system (CNS) metastasis will be eligible if they are clinically stable.

Key Exclusion Criteria:

  • Uncontrolled intercurrent illness
  • Patients who have not had resolution of all clinically significant toxic effects of prior systemic cancer therapy, surgery, or radiotherapy to Grade ≤1 (except for grade ≤2 alopecia, or stable grade 2 sensory neuropathy, according to the last CTCAE version).
  • Active clinically significant cardiac disease
  • Evidence of interstitial lung disease or active, non-infectious pneumonitis.
  • History of other malignancy within the past 2 years with exceptions.

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: N / A
  • Modelo Intervencionista: Asignación Secuencial
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: [203Pb]Pb-DOTAM-MAM279/[212Pb]Pb-DOTAM-MAM279

Patients will receive [203Pb]Pb-DOTAM-MAM279 for Imaging/Dosimetry followed by [212Pb]Pb-DOTAM-MAM279 for treatment
Droga: [212Pb]Pb-MP0712

Radioligand Therapy

Otros nombres:
  • [212Pb]Pb-DOTAM-MAM279
Otro: [203Pb]Pb-MP0712

Radioligand Imaging Agent

Otros nombres:
  • [203Pb]Pb-DOTAM-MAM279

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
To assess incidence and severity of safety events following administration of [212Pb]Pb-DOTAM-MAM279
Periodo de tiempo: until 5 years after last dose

Type, frequency and severity of adverse events (AEs), and serious adverse events (SAEs), Adverse events of special interest (AESI) and Dose Limiting Toxicities (DLT) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
until 5 years after last dose
To assess dose modifications of [212Pb]Pb-DOTAM-MAM279
Periodo de tiempo: until 5 years after last dose

Frequency and duration of dose changes
until 5 years after last dose
To estimate the maximum tolerated dose (MTD) and/or to define the recommended phase 2 dose (RP2D) for SCLC/LCNEC of the lung and epNECs
Periodo de tiempo: Phase 1, from start of treatment to end of first cycle (day 1 - 28)

Incidence of dose limiting toxicities
Phase 1, from start of treatment to end of first cycle (day 1 - 28)
To evaluate the preliminary anti-tumor activity of [212Pb]Pb-DOTAM-MAM279 in the dose expansion part
Periodo de tiempo: Phase 2a only; 12 months

Objective Response Rate (ORR) in the expansion phase

ORR is defined as the percentage of patients with partial response (PR) or complete response (CR) as per RECIST v1.1
Phase 2a only; 12 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
To assess maximum concentration (Cmax) of [203Pb]Pb-DOTAM-MAM279 / [212Pb]Pb-DOTAM-MAM279
Periodo de tiempo: up to 7 days following [203Pb]Pb-DOTAM-MAM279 administration; up to 14 days following [212Pb]Pb-DOTAM-MAM279 administration]

Blood and serum samples will be drawn to determine maximum concentration (Cmax) of [203Pb]Pb-DOTAM-MAM279 / [212Pb]Pb-DOTAM-MAM279
up to 7 days following [203Pb]Pb-DOTAM-MAM279 administration; up to 14 days following [212Pb]Pb-DOTAM-MAM279 administration]
To assess the area under the curve (AUC) from time 0 to the time of the last quantifiable concentration of [203Pb]Pb-DOTAM-MAM279
Periodo de tiempo: up to 7 days following [203Pb]Pb-DOTAM-MAM279 administration; up to 14 days following [212Pb]Pb-DOTAM-MAM279 administration]

Blood and serum samples will be drawn to determine AUC of [203Pb]Pb-DOTAM-MAM279 / [212Pb]Pb-DOTAM-MAM279
up to 7 days following [203Pb]Pb-DOTAM-MAM279 administration; up to 14 days following [212Pb]Pb-DOTAM-MAM279 administration]
To assess half-live(s) (t½) of [203Pb]Pb-DOTAM-MAM279 / [212Pb]Pb-DOTAM-MAM279
Periodo de tiempo: up to 7 days following [203Pb]Pb-DOTAM-MAM279 administration; up to 14 days following [212Pb]Pb-DOTAM-MAM279 administration]

Blood and serum samples will be drawn to determine half-live(s) (t½) of [203Pb]Pb-DOTAM-MAM279 / [212Pb]Pb-DOTAM-MAM279
up to 7 days following [203Pb]Pb-DOTAM-MAM279 administration; up to 14 days following [212Pb]Pb-DOTAM-MAM279 administration]
To assess the clearance (CL) of [203Pb]Pb-DOTAM-MAM279 / [212Pb]Pb-DOTAM-MAM279
Periodo de tiempo: up to 7 days following [203Pb]Pb-DOTAM-MAM279 administration; up to 14 days following [212Pb]Pb-DOTAM-MAM279 administration]

Blood and serum samples will be drawn to determine clearance (CL) of [203Pb]Pb-DOTAM-MAM279 / [212Pb]Pb-DOTAM-MAM279
up to 7 days following [203Pb]Pb-DOTAM-MAM279 administration; up to 14 days following [212Pb]Pb-DOTAM-MAM279 administration]
To assess the volume of distribution (Vd) of [203Pb]Pb-DOTAM-MAM279 / [212Pb]Pb-DOTAM-MAM279
Periodo de tiempo: up to 7 days following [203Pb]Pb-DOTAM-MAM279 administration; up to 14 days following [212Pb]Pb-DOTAM-MAM279 administration]

Blood and serum samples will be drawn to determine the volume of distribution (Vd) of [203Pb]Pb-DOTAM-MAM279 / [212Pb]Pb-DOTAM-MAM279
up to 7 days following [203Pb]Pb-DOTAM-MAM279 administration; up to 14 days following [212Pb]Pb-DOTAM-MAM279 administration]
To quantitatively predict radiation absorbed doses for therapeutic [212Pb]Pb-DOTAM-MAM279 from [203Pb]Pb-DOTAM-MAM279
Periodo de tiempo: Phase 1; up to 7 days following [203Pb]Pb-DOTAM-MAM279 administration

Estimation of [212Pb]Pb-DOTAM-MAM279 absorbed dose for healthy organs and tumor lesions based on dosimetry analysis of [203Pb]Pb-DOTAM-MAM279
Phase 1; up to 7 days following [203Pb]Pb-DOTAM-MAM279 administration
To assess incidence and severity of safety events following administration of [203Pb]Pb-DOTAM-MAM279
Periodo de tiempo: up to 10 days following [203Pb]Pb-DOTAM-MAM279 administration

Type, frequency and severity of adverse events (AEs) and serious adverse events (SAEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
up to 10 days following [203Pb]Pb-DOTAM-MAM279 administration
To evaluate PFS
Periodo de tiempo: Phase 2a only; 12 months

Progression-Free Survival (PFS) determined as the time from C1D1 to the date of progression, defined as the first documented progression as per RECIST v1.1 or death for any cause
Phase 2a only; 12 months
To evaluate DoR
Periodo de tiempo: Phase 2a only; 12 months

Duration of response (DoR) in patients with a CR or PR from date of first date of response to the date of RECIST 1.1 progression or death
Phase 2a only; 12 months
To evaluate DCR
Periodo de tiempo: Phase 2a only; 12 months

Disease control rate (DCR) defined as the percentage of patients who have achieved CR, PR, or stable disease (SD)
Phase 2a only; 12 months
To evaluate OS
Periodo de tiempo: Phase 2a only; approx. 5 years

Overall survival (OS) defined as the time from C1D1 to death from any cause
Phase 2a only; approx. 5 years

Colaboradores e Investigadores

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

Patrocinador

Molecular Partners AG

Colaboradores

Orano Med LLC

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)

18 de mayo de 2026

Finalización primaria (Estimado)

1 de septiembre de 2028

Finalización del estudio (Estimado)

1 de septiembre de 2032

Fechas de registro del estudio

Enviado por primera vez

10 de noviembre de 2025

Primero enviado que cumplió con los criterios de control de calidad

2 de diciembre de 2025

Publicado por primera vez (Actual)

12 de diciembre de 2025

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

21 de octubre de 2026

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

20 de octubre de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • MP0712-CP101

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

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

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