A Study of an Intratumoral Oncolytic Virus in Patients with Advanced Metastatic Solid Tumors, Trial ID 9801-CL-0101

Resumen del estudio

The purpose of this study is to assess the safety and tolerability of ASP9801 and to determine the recommended phase 2 dose (RP2D). The study will also evaluate antitumor activity, objective response rate, pharmacokinetics and virus shedding of ASP9801.

Más información del estudio

Fase

Fase 1

Producto

ASP9801

Producto

N/A

Tipo

Interventional

Enmascaramiento

None (Open Label)

Número de inscripción

105

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Información del solicitante [Soy...]

A caregiver
A healthcare provider
A parent
A patient
A patient advocate

Nombre

Apellido

Correo

País/región

Alemania
Anteriormente Serbia y Montenegro
Arabia Saudita
Argelia
Argentina
Armenia
Australia
Austria
Bélgica
Bielorrusia
Bosnia y Herzegovina
Brasil
Bulgaria
Canadá
Chile
China
Colombia
Croacia
Dinamarca
Egipto
Eslovaquia
Eslovenia
España
Estados Unidos
Estonia
Federación de Rusia
Filipinas
Finlandia
Francia
Georgia
Grecia
Guatemala
Hong Kong
Hungría
India
Indonesia
Irlanda
Islandia
Israel
Italia
Japón
Jordania
Kazajistán
Letonia
Líbano
Lituania
Macedonia
Malasia
Marruecos
México
Montenegro
Noruega
Nueva Zelanda
Países Bajos
Panamá
Perú
Polonia
Portugal
Puerto Rico
Reino Unido
República Checa
República de Corea
República de Moldavia
República Dominicana
Rumania
Serbia
Singapur
Sudáfrica
Suecia
Suiza
Tailandia
Taiwán, provincia de China
Turquía
Ucrania
Vietnam

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Ubicaciones

Contáctenos

Reclutamiento

UNC Healthcare

Chapel Hill, North Carolina, Estados Unidos, 27514

Contáctenos

Reclutamiento

Mary Crowley Cancer Research Center

Dallas, TX, Estados Unidos, 75251

Contáctenos

Withdrawn

University of Toledo Medical Center

Toledo, OH, Estados Unidos, 43614

Contáctenos

Reclutamiento

The Angeles Clinic and Research Institute

Los Angeles, CA, Estados Unidos, 90025

Contáctenos

Reclutamiento

Nebraska Methodist Hospital

Omaha, NE, Estados Unidos, 68130

Contáctenos

Reclutamiento

Seattle Cancer Care Alliance

Seattle, WA, Estados Unidos, 98109

Contáctenos

Reclutamiento

University of Arizona – Arizona Cancer Center

Tucson, Arizona, Estados Unidos, 85719

Contáctenos

Reclutamiento

Greenville Health System Cancer Institute

Greenville, SC, Estados Unidos, 27605

Contáctenos

Reclutamiento

University of Pittsburgh Medical Center

Pittsburgh, PA, Estados Unidos, 15260

Contáctenos

Reclutamiento

The University of Texas - MD Anderson Cancer Center

Houston, TX, Estados Unidos, 77030

Contáctenos

Reclutamiento

Henry Ford Hospital

Detroit, MI, Estados Unidos, 48202

Contáctenos

Reclutamiento

UVA Cancer Center

Charlottesville, Virginia, Estados Unidos, 22903

Contáctenos

Reclutamiento

Ochsner Clinic Foundation

New Orleans, Louisiana, Estados Unidos, 70121

Contáctenos

Información del estudio

Estudio de seguimiento

Edad

18 años de edad en adelante

Afección

Cáncer avanzado/metastásico

Sexo

Mujer y hombre

Fechas del estudio

Aug 2019 - Oct 2024

Compartir con

Más información del estudio

Criterios de inclusión

Subject must have histologically- or cytologically-confirmed diagnosis of advanced or metastatic

solid tumor(s).

Subject has measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. At least 1 lesion must be suitable for intratumoral (IT) injection. Lesions for injection must be ≥ 10 mm and ≤ 60 mm in longest diameter.
Subject has progressed on or is not eligible for available standard therapy.
Subject has a predicted life expectancy ≥ 12 weeks.
Subject has at least 2 sites of disease suitable for biopsy and is willing and able to undergo required tumor biopsies according to the treating institution’s guidelines at screening and during study treatment.
Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
A female subject is eligible to participate if she is not pregnant and at least 1 of the following conditions applies:
- No es una mujer en edad fértil (MEF).

WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 180 days after the final study investigational product (IP) administration.
Female subject must agree not to breastfeed starting at screening, and throughout the study period and 180 days after the final study IP administration.
Female subject must not donate ova starting at screening, and throughout the study period and for 180 days after the final study IP administration.
Male subject must agree to remain abstinent or use a condom throughout the study period and for 180 days after the final study IP administration.
Male subject with female partner(s) of childbearing potential must agree to use contraception during the treatment period and for at least 180 days after the final study IP administration.
Male subject must not donate sperm during the treatment period and for at least 180 days after the final study IP administration.
Subject must be willing and able to comply with the study requirements including prohibited concomitant medication restrictions.
Subject agrees not to participate in another interventional study while receiving study IP.
Subject has the ability to understand and the willingness to sign a written informed consent document.

Criterios de exclusión

Subject has ongoing toxicity ≥ Common Terminology Criteria for Adverse Events (CTCAE) grade 2 attributable to prior antineoplastic therapies considered clinically significant.
Subject who has had major surgery ≤ 4 weeks of screening.
Subject is concurrently participating in another interventional study or has received an investigational product ≤ 30 days or 5 half-lives whichever is shorter, prior to first IP administration.
Subject with symptomatic or untreated central nervous system metastases or leptomeningeal disease. Subjects with treated symptomatic brain metastases should be neurologically stable (for 4 weeks post-treatment and prior to screening) and off steroids for at least 2 weeks prior to first IP administration.
Subject with active or prior autoimmune or inflammatory disorders requiring systemic therapy within past 2 years (including inflammatory skin conditions or severe eczema, inflammatory bowel disease (e.g., colitis or Crohn’s disease), diverticulitis (with the exception of diverticulosis), celiac disease, systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome (granulomatosis with polyangiitis), Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, etc.

The following are exceptions to this criterion:

Subject with vitiligo or alopecia
Subject with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
Any chronic skin condition that does not require systemic therapy
Subject with another malignancy that currently requires treatment.
Subject with tumors encasing major vascular structures such as the carotid artery, tumors adjacent to vital neurovascular structures or tumors in locations that are at high risk for adverse events (AEs) or otherwise not considered appropriate for IT injection.
Subject with inadequate organ and marrow functions meeting any of the below criteria:
- Leukocytes < 3000/μL
- Absolute neutrophil count < 1500/μL
- Platelets < 100,000/μL
- Hemoglobin (Hgb) < 9 g/dL
- International normalized ratio (INR) > 1.5 × ULN and/or activated partial thromboplastin time (aPTT) > 1.5 × institutional normal limits, except for patients in Group B (Visceral Lesions) escalation and expansion groups where

INR and aPTT must be normal

Total Bilirubin (TBL) > 1.5 × institutional normal limits (subjects with known Gilbert syndrome who are excluded if TBL > 3.0 × institutional normal limits or direct bilirubin > 1.5 × institutional normal limits)
Aspartate aminotransferase (AST) and Alanine transaminase (ALT) > 3.0 × institutional normal limits. Subjects with tumors in the liver AST and ALT > 5 × institutional normal limits.
Albumin < 3.4 g/dL
Creatinine > 1.5 × institutional normal limits
Subject with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of first administration of study IP. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of

active autoimmune disease.

Subject has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, any form of substance abuse or psychiatric illness/social situations that would limit compliance with study visits or requirements or a condition that could invalidate communication with the investigator.
Subject is known to be positive for human immunodeficiency virus, hepatitis B surface antigen, hepatitis B core immunoglobulin or immunoglobulin G (IgG) antibody or hepatitis C (IgG or ribonucleic acid (RNA) test) indicating acute or chronic infection.
Subject has a history of moderate to severe ascites, clinically significant and/or rapidly accumulating ascites, bleeding esophageal varices, hepatic encephalopathy or pericardial and/or pleural effusions related to liver insufficiency within 6 months of screening. Mild ascites that does not preclude safe IT injection of ASP9801 is allowed.
Subject has a clinically significant abnormal electrocardiogram (ECG) at screening.
Subject has symptomatic cardiovascular disease within the preceding 12 months unless cardiology consultation and clearance has been obtained for study participation, including but not limited to the following: significant coronary artery disease (e.g., requiring angioplasty or stenting), acute myocardial infarction or unstable angina pectoris < 3 months prior to screening, uncontrolled hypertension, clinically significant arrhythmia or congestive heart failure (New York Heart Association grade ≥ 2).
Subject has medical conditions that predispose the subject to untoward medical risk in the event of volume loading (e.g., intravenous fluid bolus infusion), tachycardia or hypotension during or following treatment with ASP9801.
Subject has a known or suspected hypersensitivity to ASP9801 or any components of the formulation used, including prior adverse reaction to vaccinia (e.g., as smallpox vaccine).
Subject has had previous exposure with ASP9801.

Preguntas frecuentes

¿Los estudios clínicos son solo para personas con cáncer avanzado?

Si bien algunos estudios clínicos pueden enfocarse en cánceres más avanzados, muchos estudios están abiertos para pacientes con cáncer en diferentes etapas. Cada estudio tiene reglas que establecen quiénes pueden participar. Por ejemplo, quizás solo puedan participar pacientes de un grupo de edad determinado o aquellos que tengan un tipo determinado de tumor.

¿Será necesario que interrumpa mi tratamiento actual para participar en un estudio clínico?

A veces los investigadores quieren que los participantes sigan recibiendo sus tratamientos actuales durante un estudio clínico. En otras ocasiones, es posible que deba interrumpir sus tratamientos actuales durante un tiempo. Si el tratamiento en investigación no funciona, siempre puede volver a su plan de tratamiento original.

¿Debería preocuparme la posibilidad de recibir placebo?

En los estudios clínicos oncológicos, solo se usa placebo si no hay otro tratamiento disponible para ese tipo de cáncer. Esto ayuda a comparar un tratamiento en investigación con el placebo. Los placebos rara vez se usan en estudios oncológicos, porque en su lugar generalmente se administra el mejor tratamiento disponible, que se denomina “estándar de atención”.

¿Necesito una derivación de mi médico para participar en un estudio?

Es posible que su médico no conozca todas las oportunidades de participación en estudios clínicos que usted tiene a su disposición. Hable con su médico o con otro profesional de la salud sobre la información que encuentre en relación con un estudio clínico. Podrán ayudarlo a decidir si el estudio clínico es adecuado para usted. Si no encuentra ninguna opción en este sitio web, le recomendamos que visite un registro público en línea, por ejemplo, clinicaltrials.gov para conocer los diversos estudios clínicos que están disponibles.

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A Study of an Intratumoral Oncolytic Virus in Patients with Advanced Metastatic Solid Tumors

Resumen del estudio

Más información del estudio

Obtenga más información

Ubicaciones

Preguntas frecuentes

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