A Study to Learn About the Study Medicine Called PF-08098488 in People With Advanced Solid Tumors.
A PHASE 1, OPEN-LABEL STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTITUMOR ACTIVITY OF PF-08098488 IN ADULT PARTICIPANTS WITH ADVANCED SOLID TUMORS.
The purpose of this clinical study is to learn about the safety and effects of the study medicine (called PF-08098488) in people with advanced solid tumors (cancer that cannot be removed with surgery or has spread to other parts of the body). PF-08098488 is being studied as a possible treatment for certain types of cancer. These include non-small cell lung cancer, pancreatic cancer, stomach or gastroesophageal junction cancer, and esophageal cancer. This study will also help researchers learn how the study medicine moves through and affects the body.
This study is seeking adults who:
- Have advanced non-small cell lung cancer, pancreatic cancer, stomach or gastroesophageal junction cancer, or esophageal cancer.
- Have received at least 1 previous treatment for their cancer.
- Have cancer that has grown, returned, or is no longer responding to available treatments.
All participants in this study will receive PF-08098488 as an IV infusion (given directly into a vein) at the study clinic. Researchers will study different dose levels and dosing schedules to find the dose that is safe and may work best. Participants will be monitored closely during treatment, especially after their first infusion. They may continue receiving the study medicine as long as their cancer is not getting worse and they are tolerating treatment.
The study includes a screening period of up to 28 days. Participants will have regular visits to the study clinic for treatment and health assessments. These assessments include scans to monitor the cancer and blood sample collection. Tumor tissue samples will also be collected when available or medically feasible. After treatment ends, participants will have a follow-up visit about 1 month later. They will then be contacted about every 12 weeks to check on their health.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Pfizer CT.gov Call Center
- Número de teléfono: 1-800-718-1021
- Correo electrónico: ClinicalTrials.gov_Inquiries@pfizer.com
Ubicaciones de estudio
-
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Michigan
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Grand Rapids, Michigan, Estados Unidos, 49546
- Reclutamiento
- START Midwest, LLC
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37203
- Reclutamiento
- Sarah Cannon Research Institute - Pharmacy
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Nashville, Tennessee, Estados Unidos, 37203
- Reclutamiento
- SCRI Oncology Partners
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Texas
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San Antonio, Texas, Estados Unidos, 78229
- Reclutamiento
- START San Antonio, LLC
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 18 years of age or older
- Advanced non-small cell lung cancer, pancreatic ductal adenocarcinoma, gastric cancer (including gastroesophageal junction carcinoma), or esophageal cancer.
- Eastern Cooperative Oncology Group (ECOG) Performance status 0-1
- Measurable disease
- Must have received at least 1 prior approved systemic therapy:
- Part 1: progression or relapse following standard treatments and have no other appropriate standard of care option.
- Part 2: maximum of 2 prior lines of systemic therapy in the advanced setting.
- Resolution of acute effects of prior anticancer therapy to baseline or Grade 1
- Consent to submit required pre-treatment tumor tissue as medically feasible
Exclusion Criteria:
- Received prior treatment with an antibody drug conjugate with an auristatin or microtubule inhibitor payload.
- Unacceptable renal, hepatic, hematologic, cardiologic, pulmonary, or abnormalities as defined by the protocol.
- Pre-existing sensory or motor neuropathy.
- Uncontrolled diabetes mellitus.
- Clinically significant and/ or symptomatic eye disease meeting protocol exclusion criteria.
- Pulmonary (lung) disease meeting protocol exclusion criteria.
Plan de estudios
¿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
Different groups of participants will receive different doses and/or schedules of the study drug |
IV infusion |
|
Experimental: Part 2 Dose Expansion
Participants in tumor-specific groups will receive 1 dosing regimen deemed to be safe in Part 1 |
IV infusion |
|
Experimental: Part 2 Dose Optimization
Participants will be assigned to one of two dosing regimens deemed to be safe in Part 1 |
IV infusion |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence of Adverse Events (AEs)
Periodo de tiempo: Start of study treatment to 30 days after the last dose of study drug administration or start of new anticancer therapy (whichever occurs first)
|
Number of participants with AEs, characterized by type, frequency, severity, seriousness, and relationship to study intervention during the AE evaluation period. |
Start of study treatment to 30 days after the last dose of study drug administration or start of new anticancer therapy (whichever occurs first)
|
|
Part 1: Recommended Monotherapy Dose(s) for Expansion (RDEM)
Periodo de tiempo: From first dose through completion of Part 1, an average of 1 year
|
From first dose through completion of Part 1, an average of 1 year
|
|
|
Part 2: Recommended Monotherapy Dose for Further Development
Periodo de tiempo: From first dose through completion of Part 2, an average of 2 years
|
From first dose through completion of Part 2, an average of 2 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Objective Response Rate (ORR)
Periodo de tiempo: From baseline until first documented disease progression, death, or start of new anticancer therapy, whichever occurs first, up to approximately 3 years
|
Percentage of participants with a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the investigator. |
From baseline until first documented disease progression, death, or start of new anticancer therapy, whichever occurs first, up to approximately 3 years
|
|
Duration of Response (DOR)
Periodo de tiempo: From the date of first objective response until disease progression or death due to any cause, whichever occurs first, up to approximately 3 years
|
Time in weeks/months from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. |
From the date of first objective response until disease progression or death due to any cause, whichever occurs first, up to approximately 3 years
|
|
Progression Free Survival (PFS)
Periodo de tiempo: From first dose until disease progression or death due to any cause, whichever occurs first, up to approximately 3 years
|
PFS as defined per RECIST 1.1. |
From first dose until disease progression or death due to any cause, whichever occurs first, up to approximately 3 years
|
|
Overall Survival (OS)
Periodo de tiempo: From first dose until death due to any cause, up to approximately 3 years
|
Time in weeks from the start of study treatment to date of death due to any cause. |
From first dose until death due to any cause, up to approximately 3 years
|
|
Maximum Observed Serum Concentration (Cmax)
Periodo de tiempo: From first dose through End of Treatment (EOT), up to approximately 3 years
|
From first dose through End of Treatment (EOT), up to approximately 3 years
|
|
|
Area under the concentration-time curve (AUC)
Periodo de tiempo: From first dose through End of Treatment (EOT), up to approximately 3 years
|
From first dose through End of Treatment (EOT), up to approximately 3 years
|
|
|
Time to Maximum Observed Serum Concentration (Tmax)
Periodo de tiempo: From first dose through End of Treatment (EOT), up to approximately 3 years
|
From first dose through End of Treatment (EOT), up to approximately 3 years
|
|
|
Number of Participants With Anti-drug Antibody (ADA) against PF-08098488
Periodo de tiempo: Start of study treatment to 30 days after last dose of study drug administration
|
Start of study treatment to 30 days after last dose of study drug administration
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Pfizer CT.gov Call Center, Pfizer
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Procesos Patológicos
- Neoplasias por sitio
- Neoplasias
- Enfermedades de las vías respiratorias
- Neoplasias por tipo histológico
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Enfermedades del Estómago
- Enfermedades pulmonares
- Neoplasias de glándulas endocrinas
- Neoplasias de Cabeza y Cuello
- Enfermedades pancreáticas
- Neoplasias Glandulares y Epiteliales
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Procesos Neoplásicos
- Enfermedades esofágicas
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Condiciones Patológicas, Signos y Síntomas
- Neoplasias de Estómago
- Carcinoma
- Neoplasias Pulmonares
- Neoplasias Esofágicas
- Metástasis de neoplasias
- Neoplasias pancreáticas
- Carcinoma de pulmón de células no pequeñas
Otros números de identificación del estudio
- C6261001
- CEACAM5 EC4V (Otro identificador: Alias Study Number)
- 2026-527660-32-00 (Identificador de registro: CTIS (EU))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .