Aún no reclutaNCT07928258Registro de ClinicalTrials.gov

A Study of LY4336619 in Adult Participants With Advanced Solid Tumors

Endometrial Neoplasms · Ovarian Neoplasms · Neoplasms, Germ Cell and Embryonal · Carcinoma, Non-Small-Cell Lung · Stomach Neoplasms · Neoplasms

Pregúntale a WCR sobre este estudio Registro oficial ↗

LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio: De intervención
Fase: Fase 1
Rango de edad: 18 años - No especificado
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 370 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

The main purpose of this study is to evaluate how safe and effective LY4336619 is in adults with advanced cancer. Some participants will receive LY4336619 alone, and some will receive it with another cancer medicine. Participants will be in the study for up to 2 years, depending on how they tolerate and respond to treatment.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

Have histological diagnosis of locally advanced or metastatic solid tumor malignancy.
Have a life expectancy of at least 12 weeks as judged by the investigator.
Must be an appropriate candidate for study treatment. Study treatment is considered appropriate where approved measures are no longer effective or are not considered appropriate or safe in the opinion of the investigator, or the individual refuses the remaining most appropriate standard of care treatment.
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale or Karnofsky performance status of at least 80%.

Exclusion Criteria:

Has a known or suspected history of active central nervous system (CNS) involvement.
Has a history of carcinomatous meningitis.
Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease.
Residual symptoms of neurotoxicity from prior chimeric antigen receptor-modified T cell (CAR-T) or bispecifics.
Has significant cardiovascular disease
Has an active uncontrolled systemic bacterial, viral, fungal, or parasitic infection (except for fungal nail infection), or other clinically significant active disease process which, in the opinion of the investigator and the sponsor, makes it undesirable for the individual to participate in the trial. Screening for chronic conditions is not required.
Has any unresolved toxicities from prior therapy greater than National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0 Grade 1 at the time of starting study treatment except for alopecia, endocrine adverse events (AEs) on replacement therapy, and Grade 2 neuropathy.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: Sin asignación al azar
Enmascaramiento: Sin enmascaramiento

LY4336619 Dose Escalation

Escalating doses of LY4336619 administered intravenously (IV)

Drug: LY4336619

LY4336619 Dose Optimization

Comparing 2 or more doses (evaluated during dose escalation) of LY4336619 administered IV

Drug: LY4336619

LY4336619 and Sofetabart Mipitecan (Sofe-M) Combination

Comparing LY4336619 in combination with Sofe-M administered IV

Drug: LY4336619 · Drug: Sofetabart Mipitecan (Sofe-M)

LY4336619 Dose Expansion

LY4336619 administered IV

Drug: LY4336619

LY4336619 DRUG

Administered IV

Sofetabart Mipitecan (Sofe-M) DRUG

Administered IV

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Number of Participants with Dose-Limiting Toxicities (DLTs)

Plazo: From Cycle 1 Day 1 through Cycle 2 Day 1 (approximately 21 days)

No informado en este registro.

Objective Response Rate (ORR) of LY4336619 in the Dose Expansion Arms