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Inhibidor selectivo de TrkA VMD-928 para tratar tumores sólidos o linfomas provocados por la sobreexpresión de TrkA

30 de octubre de 2026 actualizado por: VM Oncology, LLC

Un estudio abierto, de dosis múltiples y de aumento de dosis para investigar la seguridad, la farmacocinética y la farmacodinámica de VMD-928 en sujetos con tumores sólidos o linfoma

This is a multicenter, open-label, Phase 1/2 study of orally administered VMD-928 monotherapy and in combination with pembrolizumab in adult subjects with advanced solid tumors or lymphoma that have progressed or are non responsive to available therapies and for which no standard or available curative therapy exists

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

This is an open-label, dose-escalation (Phase 1) and expansion (Phase 2) multi-center study conducted in five parts to identify the safe and pharmacologically active doses (MTD and/orRP2D) and regimen for oral VMD-928 monotherapy and in combination with a PD-1 inhibitor, pembrolizumab in cancer patients. An immunohistochemistry (IHC) assay specific for detecting TrkA protein in tumor tissue samples has been validated and is being used to detect TrkA protein expressions in patient tumor tissue samples at Pre-screening. The study is currently focusing on the top 5 solid tumor with the highest TrkA protein overexpression are: Head and Neck Cancers (HNC), Esophageal cancer, Lung cancers, Mesothelioma, and Pancreatic Cancer.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

242

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

  • Nombre: Jay Wu, PhD
  • Número de teléfono: 101 1-510-270-2790
  • Correo electrónico: OM@VMOncology.com

Ubicaciones de estudio

  • Estados Unidos
    • California
      • Santa Rosa, California, Estados Unidos, 95403
        • Reclutamiento
        • Providence Medical Foundation (site 209)
        • Investigador principal:
          • Ian C Anderson, MD
        • Contacto:
        • Contacto:
    • Connecticut
      • Hartford, Connecticut, Estados Unidos, 06102
        • Reclutamiento
        • Hartford Hospital (site 210)
        • Contacto:
        • Investigador principal:
          • Jaykumar Thumar, MD
        • Contacto:
    • District of Columbia
      • Washington D.C., District of Columbia, Estados Unidos, 20037
        • Reclutamiento
        • The George Washington University Cancer Center (site 212)
        • Contacto:
        • Investigador principal:
          • Pavani Chalasani, MD, MPH
        • Contacto:
          • Abby Lucas
          • Número de teléfono: 1-202-994-3647
          • Correo electrónico: allucas@gwu.edu
    • Florida
      • Fort Lauderdale, Florida, Estados Unidos, 33308
        • Reclutamiento
        • Holy Cross Hospital (site 213)
        • Contacto:
        • Contacto:
        • Investigador principal:
          • Georges Azzi, MD
      • Pembroke Pines, Florida, Estados Unidos, 33028
        • Reclutamiento
        • Memorial Cancer Institute at Memorial Healthcare Systems (site 132)
        • Investigador principal:
          • Luis E Raez, MD
        • Contacto:
        • Contacto:
    • New Jersey
      • Englewood, New Jersey, Estados Unidos, 07631
        • Reclutamiento
        • Englewood Hospital and Medical Center (site 202)
        • Contacto:
        • Investigador principal:
          • Minaxi Jhawer, MD
        • Contacto:
      • Florham Park, New Jersey, Estados Unidos, 07932
        • Reclutamiento
        • Summit Medical Group (site 205)
        • Contacto:
        • Investigador principal:
          • Steven Papish, MD, FACP
      • Morristown, New Jersey, Estados Unidos, 07962
        • Reclutamiento
        • Atlantic Health System, Morristown Medical Center (site 124)
        • Investigador principal:
          • Angela Alistar, MD
        • Contacto:
        • Contacto:
    • New Mexico
      • Albuquerque, New Mexico, Estados Unidos, 87110
        • Reclutamiento
        • Presbyterian Kaseman Hospital (site 208)
        • Contacto:
          • Matthew Widdows, CCRC
          • Número de teléfono: 505-559-6089
          • Correo electrónico: mwiddows2@phs.org
        • Investigador principal:
          • Ethan Binder, MD
        • Contacto:
          • Kristina Garcia
          • Número de teléfono: 505-253-1718
          • Correo electrónico: kgarcia70@phs.org
    • New York
      • New York, New York, Estados Unidos, 10065
        • Reclutamiento
        • Weill Cornell Medicine, Cornell University (site 126)
        • Contacto:
        • Contacto:
        • Investigador principal:
          • Ashish Saxena, M.D., Ph.D.
    • Pennsylvania
      • York, Pennsylvania, Estados Unidos, 17403
        • Reclutamiento
        • Cancer Care Associates of York (site 206)
        • Investigador principal:
          • Chanh Huynh, MD
        • Contacto:
        • Contacto:
    • Texas
      • Houston, Texas, Estados Unidos, 77030
        • Reclutamiento
        • The University of Texas MD Anderson Cancer Center (site 127)
        • Investigador principal:
          • David S Hong, MD
        • Contacto:
        • Contacto:
  • Puerto Rico
      • San Juan, Puerto Rico, 00935
        • Reclutamiento
        • PanOncology Trials, Hospital Oncologico - Puerto Rico Medical Center, Río Piedras (site 200)
        • Contacto:
        • Contacto:
        • Investigador principal:
          • Marcia Cruz-Correa, MD, PhD

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 a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Key Inclusion Criteria:

#. Histologically or cytologically confirmed diagnosis of any type of solid tumor malignancy or lymphoma:

Phase 1 Dose Escalation only: Subjects with

(A) any advanced solid tumors of

  1. Head and Neck Cancers ("HNC") (of any types),
  2. Esophageal cancer,
  3. Lung cancers (of any types),
  4. Mesothelioma,
  5. Pancreatic cancers,

Or,

(B) any NTRK1 gene fusion positive ("NTRK1+") solid tumors or lymphomas, that is relapsed, refractory or intolerant (R/R/I) to standard of care (SOC) and for which there is no approved or curative therapy. Additionally, patients must not be candidates for or have exhausted regimens known to provide clinical benefit, including hematopoietic stem cell transplantation in lymphoma patients if they are deemed transplant eligible.

Phase 2 Monotherapy and Combination with Pembrolizumab only:

Subjects must have

  1. TrkA-driven HNC, Esophageal, Lung, Mesothelioma, Pancreatic cancers; or,
  2. any NTRK1+ solid tumors or lymphoma*, that is R/R/I to SOC.

Key Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) Performance Status: 0 or 1.

  • Able to swallow and retain oral medication.

  • Subjects must either have available archival tumor tissue samples, or consent to tumor tissue sampling prior to the first dose.

  • Adequate organ system function as defined as follows:

    1. Absolute neutrophil count ≥1.5x10^9/L
    2. Hemoglobin ≥9g/dL
    3. Platelets ≥100x10^9/L
    4. PT/INR, PTT ≤1.5xULN
    5. Total bilirubin ≤1.5x ULN
    6. AST, ALT ≤2.5xULN
    7. Creatinine ≤1.2xULN for age, weight
    8. Calculated creatinine clearance or 24h urine creatinine clearance ≥60mL/min

Key Exclusion Criteria:

  • Received chemotherapy having delayed toxicity within the last 14 days (six weeks for prior nitrosourea or mitomycin C).

  • Received anticancer therapy with radiation, immunotherapy, and a biologic, surgery and/or tumor embolization within the past 2 weeks.

  • Received an investigational anticancer drug within 14 days or 5 half-lives of the investigational agent, whichever is longer, prior to the first dose of VMD-928. Any exceptions to the above must be approved by the Sponsor Medical Monitor.

  • Unresolved toxicity from previous anticancer therapy > CTCAE Grade 1 (except alopecia or anemia) unless agreed to by both the Sponsor Medical Monitor and the Investigator.

  • Known active infections including HIV disease.

  • Currently pregnant, nursing, or planning to become pregnant during the course of the study.

  • QTcF interval ≥ 480 msec.

  • Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.

  • Acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the past 24 weeks.

  • Unstable or uncompensated respiratory, hepatic, renal, or cardiac disease that would compromise the patient's safety or interfere with assessment of the drug.

  • Psychological, familial, sociological, geographical, or other concurrent conditions that would interfere with safety evaluation, limit the patient's ability to follow the procedures in the protocol or otherwise jeopardize compliance with the protocol. Patients with uncontrolled major depression, bipolar disorder, or severe anxiety disorder are excluded.

  • Patient has had or is currently having other malignant tumors within 3 years.

  • Patients have multiple factors that affect their oral medication.

  • Patients have long-term unhealed wounds or fractures.

  • Patients have uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage.

  • Patients are taking the following drugs and can't stop them during the study:

    • Tylenol or medicine containing acetaminophen (paracetamol).
    • Antacids (e.g. TUMS, calcium carbonate, or magnesium hydroxide), proton pump inhibitors (e.g. omeprazole), H2 blockers (e.g. famotidine), or buffered vitamins.

  • Epstein-Barr virus (EBV) negative nasopharyngeal carcinoma.

For Phase 2 only:

  • Negative result on TrkA immunohistochemistry (IHC) assay.
  • Have visceral crisis, defined as severe organ dysfunction and rapid progression of the cancer. (It is not about presence of visceral metastasis.)

For combination therapy with Pembrolizumab only:

  • Serious adverse immune related adverse events (grade 3 or 4) with previous PD-1(L1) inhibitor therapy, that were symptomatic and required prolong immunosuppression (>6 weeks).
  • Any grade Pneumonitis and Myocarditis related to prior PD-1(L1) inhibitor therapy.
  • For subjects that received PD-1(L1) inhibitors before, there should be a washout period of at least 21 days between the last day of PD-1(L1) inhibitor and first day of study medications.
  • Subjects who relapsed after prior treatment with PD-1(L1) inhibitors. Relapsed is defined as patients having best overall response of CR or PR after treatment with a PD-1(L1) inhibitor.

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: VMD-928 monotherapy

VMD-928 tablet monotherapy
Droga: VMD-928 100 mg Tablet

Taken orally once daily for 21 days per 21-day cycle

Otros nombres:
  • Monoterapia
Experimental: Combination Therapy

VMD-928 tablet in combination with fixed dose of pembrolizumab 200 mg once-very-21-day (per cycle)
Droga: VMD-928 Tablet and Pembrolizumab (200 mg)

VMD-928 tablet (oral) starting at 300 mg daily for 21 days of 21-day cycle. Pemprolizumab at fixed intravenous dose of 200 mg once-every-21 days (per cycle) for max. 6 cycles.

Otros nombres:
  • Terapia de combinación

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number and severity of treatment-emergent Adverse Events (Phase 1)
Periodo de tiempo: First cycle (21 days per cycle)

TEAE
First cycle (21 days per cycle)
To determine the recommended Phase 2 dose for VMD-928 (Phase 1)
Periodo de tiempo: First cycle (21 days per cycle)

RP2D of monotherapy
First cycle (21 days per cycle)
To determine the RP2D of VMD-928 in combination with pembrolizumab (Phase 1)
Periodo de tiempo: First cycle (21 days per cycle)

RP2D of combination therapy
First cycle (21 days per cycle)
Antitumor activity of VMD-928 in subjects with TrkA-driven tumors (Phase 2)
Periodo de tiempo: Up to 18 months

Antitumor efficacy signal for monotherapy
Up to 18 months
Antitumor activity of VMD-928 in combination with pembrolizumab in subjects with TrkA-driven tumors (Phase 2)
Periodo de tiempo: Up to 18 months

Antitumor efficacy signal for combination therapy
Up to 18 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Area under the plasma concentration versus time curve (AUC) of VMD-928.
Periodo de tiempo: On Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)

AUC
On Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
Peak plasma concentration (Cmax) of VMD-928.
Periodo de tiempo: On Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)

Cmax
On Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
Incidence of Dose Limiting Toxicities.
Periodo de tiempo: During the Cycle 1 (each cycle is 21 days)

# of DLTs
During the Cycle 1 (each cycle is 21 days)
Correlation between clinical antitumor and TrkA protein expression.
Periodo de tiempo: Up to the end of the Cycle 2 (each cycle is 21 days)

Relationship of TrkA vs. efficacy
Up to the end of the Cycle 2 (each cycle is 21 days)

Colaboradores e Investigadores

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

Patrocinador

VM Oncology, LLC

Investigadores

  • Silla de estudio: Clinical Development, VM Oncology

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)

8 de junio de 2018

Finalización primaria (Estimado)

1 de diciembre de 2027

Finalización del estudio (Estimado)

1 de junio de 2028

Fechas de registro del estudio

Enviado por primera vez

29 de abril de 2018

Primero enviado que cumplió con los criterios de control de calidad

1 de junio de 2018

Publicado por primera vez (Actual)

14 de junio de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de noviembre de 2026

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

30 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • VMO-01C

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

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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