A study to find a suitable dose of ASP5834 in adults with solid tumorsTrial ID 5834-CL-1001

Resumen del estudio

The main aims (primary objectives) of this trial are:

To check if ASP5834 given by itself or given with panitumumab, can control people’s tumors
To find a suitable dose of ASP5834 given by itself or given with panitumumab.

Other aims (secondary objectives) are:

To check how ASP5834 given by itself or given with panitumumab is processed by the body (pharmacokinetics, or PK).
To check how ASP5834 given by itself or given with panitumumab is processed by the body (pharmacokinetics, or PK).
To check how ASP5834 acts upon the body and KRAS protein levels (pharmacodynamics, or PD).

Más información del estudio

Fase

Fase 1

Producto

N/A

Producto

ASP5834

panitumumab

Tipo

Interventional

Enmascaramiento

None (Open Label)

Número de inscripción

364

Mostrar más información del estudio

Who May Participate

People in this study will be adults with locally advanced, unresectable, or metastatic solid tumors with certain KRAS gene mutations. Locally advanced means the cancer has spread to nearby tissue. El término “irresecable” significa que el cáncer no se puede extirpar mediante cirugía. El término “metastásico” significa que el cáncer se ha diseminado a otras partes del cuerpo. The key reasons people cannot take part are if they have specific uncontrollable cancers such as symptomatic or untreated cancers in nervous system, or have a specific heart condition, or infections.

What to expect

In this study, ASP5834 is being given to humans for the first time. Este es un estudio abierto. This means that people in this study and clinic staff will know that they will receive ASP5834 by itself or ASP5834 with panitumumab.

Este estudio se realizará en 2 partes.

Part 1 is called Dose Escalation. Different small groups of people will receive lower to higher doses of either: ASP5834 by itself or ASP5834 together with panitumumab. Only people who have colorectal cancer will receive ASP5834 together with panitumumab. People with any type of solid tumor will receive ASP5834 by itself. For each dose, all medical problems will be recorded. A medical expert panel will check the results and decide if the next group can receive a higher dose of ASP5834. The panel will do this until the planned maximum number of people are treated or until suitable doses have been selected for Part 2.

Part 2 is called Dose Expansion. Other different small groups of people will receive ASP5834 or ASP5834 together with panitumumab. They will receive the most suitable doses worked out from Part 1.

In both parts of the study, the study treatments ASP5834 and panitumumab will be given through a vein. Este procedimiento se llama “infusión”. Cada ciclo de tratamiento dura 21 o 28 días. People will continue study treatment until:

they have medical problems from the study treatment they can’t tolerate;
their cancer gets worse;
they start other cancer treatment;
or they ask to stop study treatment.

People will visit the clinic on certain days during their study treatment, with extra visits during the first 2 cycles of study treatment. The study doctors will check for any medical problems from ASP5834. Also, people in the study will have a health check. On some visits they will also have scans to check for any changes in their cancer. Tumor samples will be taken at certain visits during study treatment with the option of a tumor sample being taken if people’s cancer gets worse or the cancer comes back.

People will visit the clinic shortly after stopping treatment for a health check. After this, people will have health checks every couple of months to check the condition of their cancer. The number of visits and checks done will depend on the health of each person and whether they completed their study treatment or not. It is expected that people will be in this study for about 1 year.

Length of study treatment

Approximately 12 months

Number of study visits

Varies by participant

Trial purpose

Genes contain genetic code which tell the body which proteins to make. Many types of cancer are caused by changes, or mutations, in a gene called KRAS. Researchers are looking for ways to stop the actions of abnormal proteins made from the mutated KRAS gene.

ASP5834 is a potential new treatment for solid tumors in people who have certain KRAS gene mutations. Some people with solid tumors of the colon or rectum (colorectal cancer), will be given ASP5834 with panitumumab. Panitumumab is a treatment for colorectal cancer. In this study, the researchers will learn how ASP5834 is processed by and acts upon the body. This information will help find a suitable dose of ASP5834 and check for potential medical problems from the treatment

Obtenga más información

¿Le gustaría obtener más información sobre los centros del estudio clínico que están reclutando a participantes para el estudio A study to find a suitable dose of ASP5834 in adults with solid tumors? Comuníquese con nosotros completando sus datos a la derecha y le responderemos.

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

Al hacer clic en [“Continuar/Enviar”], usted acepta que Astellas se comunique con usted por correo electrónico con información que lo ayude a conectarse con los centros de estudios clínicos. Si bien podemos conectarlo con los centros de estudios clínicos, no podemos responder preguntas sobre ningún tratamiento en investigación por correo electrónico. Su consentimiento para recibir correos electrónicos no es un requisito para participar en un estudio o estudio clínico. Para obtener más información, incluida la forma de cancelar la suscripción en cualquier momento, consulte nuestro Aviso de privacidad y política de cookies.

Doy mi consentimiento para el procesamiento de mis datos personales mencionados anteriormente de acuerdo con el Aviso de privacidad y la política de cookies de Astellas.

Ubicaciones

No se encontraron ubicaciones.

Información del estudio

Estudio de seguimiento

Edad

18 años de edad en adelante

Afección

Cáncer avanzado/metastásico

Cáncer de pulmón no microcítico

Cáncer de páncreas

Colorectal Cancer

Sexo

Mujer y hombre

Fechas del estudio

Jul 2025 - Nov 2028

Compartir con

Más información del estudio

Criterios de inclusión

Participant has histologically confirmed locally advanced (unresectable) or metastatic solid tumor malignancy with a documented Kirsten rat sarcoma viral oncogene homolog (KRAS) G12V, G12D, G12C, G12R, G12A or G13D mutation or KRAS amplification (copy number >/= 4) determined by local testing.
- For a participant with a documented KRAS amplification, only those with no other co-occurring KRAS mutation or those with a co-occurring KRAS G12V, G12D, G12C, G12R, G12A or G13D mutation are eligible.
- Unique to Europe (EU): Only participants who have pre-existing local results can be enrolled.
For the ASP5834 monotherapy dose escalation part, participant with any histologically confirmed locally advanced (unresectable) or metastatic solid tumor malignancy is eligible. Participant must have received prior standard therapy in the advanced setting, and the investigator does not see any further clinical benefit from continuing such therapy or the participant is ineligible to receive or has refused standard approved therapies.
For the ASP5834 monotherapy dose expansion part, the following criteria apply:
- [pancreatic ductal adenocarcinoma (PDAC) Expansion Cohort(s)] Participant has histologically confirmed locally advanced (unresectable) or metastatic PDAC.
- [PDAC Expansion Cohort(s)] Participant has a documented KRAS G12V, G12D, G12C, G12R, G12A or G13D mutation determined by local testing.
- [PDAC Expansion Cohort(s)] Participant must have received standard therapy in the advanced setting, including prior therapy with a gemcitabine-based or fluoropyrimidine-based regimen or have declined or is ineligible for these therapies.
- [PDAC Expansion Cohort(s)] No more than 2 prior lines of systemic therapy are allowed in the advanced setting (note: maintenance therapy does not count as a separate line of therapy).
- [PDAC Expansion Cohort(s)] For a participant who received prior neoadjuvant or adjuvant chemotherapy and had recurrence on or within 6 months of completion of therapy, the neoadjuvant or adjuvant chemotherapy should be counted as a regimen in the advanced setting.
- [non-small cell lung cancer (NSCLC) Expansion Cohort(s)] Participant has histologically confirmed locally advanced (unresectable) or metastatic NSCLC.
- [NSCLC Expansion Cohort(s)] Participant has a documented KRAS G12V, G12D, G12R, G12A or G13D mutation determined by local testing.
- [NSCLC Expansion Cohort(s)] Participant must have received standard therapy in the advanced setting, including prior platinum-based chemotherapy and checkpoint inhibitor therapy or have declined or is ineligible for these therapies.
- [NSCLC Expansion Cohort(s)] For a participant who has received prior neoadjuvant or adjuvant therapy and had recurrence during or within 6 months of completion of therapy, the neoadjuvant or adjuvant therapy should be counted as a regimen in the advanced setting (for those who received perioperative therapy, the entire course should be counted as therapy in the advanced setting).
- [NSCLC Expansion Cohort(s)] For a participant with a history of unresectable Stage III disease who received prior multi-modal therapy and had recurrence on or within 6 months of completion of therapy, the multi-modal therapy should be counted as a therapy in the advanced setting. If chemoradiation was followed by treatment with checkpoint inhibitor therapy without documented progression between chemoradiation and checkpoint inhibitor therapy, the entire treatment course should be counted as therapy in the advanced setting.
- [Other Solid Tumor Expansion Cohort] Participant has a histologically confirmed locally advanced (unresectable) or metastatic solid tumor type other than PDAC, colorectal cancer (CRC) or NSCLC.
- [Other Solid Tumor Expansion Cohort] Participant has a documented KRAS G12V, G12D, G12C, G12R, G12A or G13D mutation or KRAS amplification (copy number >/=4) determined by local testing.
- [Other Solid Tumor Expansion Cohort] Participant must have received prior standard therapy in the advanced setting, and the investigator does not see any further clinical benefit from continuing such therapy or is ineligible to receive or has refused standard approved therapies.
For ASP5834 combination therapy dose escalation and dose expansion parts, the following criteria apply:
- [CRC Dose Escalation and Dose Expansion Parts] Participant has histologically confirmed locally advanced (unresectable) or metastatic adenocarcinoma of the colon or rectum.
- [CRC Dose Escalation and Dose Expansion Parts] Participant has a documented KRAS G12V, G12D, G12C, G12R, G12A or G13D mutation determined by local testing.
- [CRC Dose Escalation and Dose Expansion Parts] Participant must have received standard therapy in the advanced setting, including prior therapy with fluoropyrimidine, oxaliplatin and irinotecan or have declined or is ineligible for these therapies.
- [CRC Dose Escalation and Dose Expansion Parts] For a participant who has received neoadjuvant or adjuvant chemotherapy and had recurrence during or within 6 months of completion of therapy, the neoadjuvant or adjuvant chemotherapy should be counted as a regimen in the advanced setting.
- [CRC Dose Escalation and Dose Expansion Parts] Participant with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) must have also received prior treatment with immune checkpoint inhibitors or have declined or is ineligible for these therapies.
Participant consents to provide tumor specimen in a tissue block or unstained serial slides or a baseline tumor biopsy obtained after the last interventional treatment, but not more than 90 days prior to the start of study intervention. Participant also consents to provide a tumor biopsy during the treatment period as indicated in the schedules of assessments. If a participant cannot provide a tumor specimen or undergo a baseline tumor biopsy procedure no more than 90 days prior to the start of study intervention, contact the medical monitor. Submission of an archival tumor tissue specimen to the central laboratory in addition to the baseline specimen is highly encouraged.
El participante tiene por lo menos 1 lesión medible de acuerdo con los Criterios de evaluación de la respuesta en tumores sólidos (Response Evaluation Criteria in Solid Tumors, RECIST), versión 1.1. Las lesiones situadas en un área previamente irradiada se consideran medibles si se ha demostrado progresión en dichas lesiones.
Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Participant’s adverse event (AEs) (excluding alopecia) from prior anti-cancer therapy have improved to Grade 1 or baseline at least 14 days prior to the start of study intervention. Persistent Grade 2 or higher toxicities from prior anti-cancer therapy that are considered clinically irreversible, may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and sponsor.
Participant has adequate organ function as indicated by laboratory values (if a participant has received a recent blood transfusion, the laboratory tests must be obtained >/= 14 days after any blood transfusion).
Female participant is not pregnant confirmed by pregnancy test and medical evaluation by interview, and at least 1 of the following conditions apply:
- No es una mujer en edad fértil (MEF).
- WOCBP who has a negative urine or serum pregnancy test within 7 days prior to day 1 and agrees to follow the contraceptive guidance from the time of informed consent through at least 6 months after final investigational study intervention administration.
Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 6 months after final investigational study intervention administration.
Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period and for 6 months after final investigational study intervention administration.
Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 3 months after final investigational study intervention administration.
Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 3 months after final investigational study intervention administration.
Male participant must not donate sperm during the treatment period and for 3 months after final investigational study intervention administration.
Participant agrees not to participate in another interventional study while receiving study intervention in the present study/participating in the present study.

Criterios de exclusión

El participante tiene metástasis en el sistema nervioso central (SNC) sintomáticas o no tratadas. Participants with stable, asymptomatic and treated CNS metastases are eligible.
El participante tiene una enfermedad leptomeníngea como manifestación de la neoplasia maligna actual.
Participant has another prior malignancy active (i.e., requiring treatment or intervention) within the previous 2 years different from the primary malignancy for this study, except for local malignancies that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast, which are allowed.
Participant with active hepatitis B (including acute hepatitis B virus (HBV) or chronic HBV) or hepatitis C virus (HCV) (Ribonucleic acid (RNA) detected by qualitative assay). No se requiere la prueba del ARN del VHC en los participantes con un resultado negativo en la prueba de anticuerpos contra el VHC.
Participant has a known history of human immunodeficiency virus (HIV) infection with Acquired Immune Deficiency Syndrome (AIDS) related complications. No se requiere ninguna prueba del VIH a menos que lo exija una autoridad de salud local.
Participant has had a myocardial infarction or unstable angina within 6 months prior to the start of study intervention or currently has an uncontrolled illness including, but not limited to symptomatic congestive heart failure, clinically significant cardiac disease, unstable angina pectoris, cardiac arrhythmia, obligate use of a cardiac pacemaker, or long QT syndrome.
El participante se sometió a una cirugía mayor en las 4 semanas anteriores a la primera dosis de la intervención del estudio.
Participant has received any radiotherapy (including stereotactic radiosurgery) within 14 days prior to the first dose of study intervention.
Participant has received prior KRAS targeting agents (including but not limited to KRAS directed inhibitors, degraders, small interfering RNA [siRNA] therapies, vaccines and cellular therapies), with the following exceptions:
- In the dose escalation part, a participant with PDAC or NSCLC who has received prior RMC-6236 or RMC-9805 or a participant with NSCLC who has received prior KRAS G12C inhibitors but no other KRAS targeting agents will be eligible.
El participante tiene una infección activa que requiere antibióticos por vía intravenosa dentro de los 14 días anteriores a la intervención del estudio.
Participant is expected to require another form of anticancer therapy while on study treatment.
Participant requires treatment with concomitant drugs that are strong or moderate inhibitors or inducers of Cytochrome P450 family 3 subfamily A (CYP3A).
La participante ha recibido cualquier terapia de investigación dentro de los 28 días o 5 semividas, el período que sea más largo, antes de la selección.
El participante tiene cualquier afección por la cual es inadecuado para participar en el estudio.
Participant has a known or suspected hypersensitivity to the protocol specified study intervention(s) or any components of the formulation used.
Participant has a corrected QT interval by Fridericia (QTcF) value (single electrocardiogram (ECG)) of > 470 msec during screening.
Participant has a left ventricular ejection fraction (LVEF) < 50% as assessed by echocardiogram (ECHO) (or multigated acquisition (MUGA)) performed at screening.
Participant with a known history of an acquired KRAS G12V, G12D, G12C, G12R, G12A or G13D mutation or KRAS amplification identified as a resistance mechanism to prior systemic therapy (note: if a participant has more than 1 relevant KRAS alteration [KRAS G12V, G12D, G12C, G12R, G12A or G13D mutation or KRAS amplification], only those with a known history of acquired resistance to all relevant KRAS alterations would be excluded). Participant will not be excluded if it is not known whether the KRAS alteration(s) were acquired as a resistance mechanism.
UNIQUE to EU: Participant who is the subject of any legal protection measures under local legislation will not be allowed.
[ASP5834 combination therapy] Participant had prior discontinuation of panitumumab treatment due to toxicity or intolerance of panitumumab.
[ASP5834 combination therapy] Participant has a history of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis.

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.

Seguir leyendo

A study to find a suitable dose of ASP5834 in adults with solid tumors

Resumen del estudio

Más información del estudio

Who May Participate

What to expect

Trial purpose

Obtenga más información

Ubicaciones

Preguntas frecuentes

Seguir leyendo

¿Qué son los estudios clínicos?

¿Por qué son importantes los estudios clínicos?

¿Por qué participar en un estudio clínico?