ReclutandoNCT06581432Registro de ClinicalTrials.gov

Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations

Solid Tumours

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LO ESENCIAL

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio: De intervención
Fase: Fase 2
Rango de edad: 18 años - No especificado
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 588 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

This is a study for people with advanced cancer for whom previous treatment was not successful. Adults aged 18 and over with advanced cancer with HER2 alterations can join the study. The purpose of this study is to find out whether a medicine called zongertinib helps people with advanced cancers with HER2 alterations. HER2 alterations can cause cancer. Zongertinib inhibits HER2.

Participants are put into groups based on the type of advanced cancer they have, the type of HER2 alterations they have, and the dose of zongertinib they receive. Depending on the group they are in, participants take 1 of 2 different doses of zongertinib each day. Participants can continue the treatment as long as they benefit from it and can tolerate it.

Participants visit the study site regularly. During many of the visits, the doctors check the size of the tumour and whether it has spread to other parts of the body. During all the visits, the doctors check participants' health and take note of any unwanted effects.

¿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:

Patients aged ≥18 years
Documented Human epidermal growth factor receptor 2 (HER2)-positive status or known activating HER2 mutations (by local testing)
Histologically or cytologically confirmed locally advanced, unresectable, or metastatic solid tumours
Disease progression following prior treatment in the metastatic setting (including treatment with antibody-drug conjugates (ADCs)) and no suitable standard of care treatment options
Availability of archival tumour tissue sample to confirm HER2 status
Presence of ≥1 measurable lesion outside the central nervous system (CNS) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (investigator assessed)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Further inclusion criteria apply.

Exclusion criteria:

Diagnosis of HER2-positive (overexpressed/amplified) metastatic breast cancer
Diagnosis of HER2-mutant non-small cell lung cancer (NSCLC)
Previous treatment with any HER2 tyrosine kinase inhibitors (TKIs)
Previous or concomitant malignancies other than the one treated in this trial within the previous 3 years except the following effectively treated cancers: nonmelanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, localized prostate cancer on watchful waiting or active surveillance, and other effectively treated malignancies that are considered cured by local treatment
Uncontrolled or symptomatic brain or subdural metastases during screening
Known diagnosis of leptomeningeal disease
Intake of restricted medications or any drug considered likely to interfere with the trial being conducted in a safe mannerFurther exclusion criteria apply.

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: No aplica
Enmascaramiento: Sin enmascaramiento

Zongertinib treatment

No informado en este registro.

Drug: Zongertinib

Zongertinib DRUG

Zongertinib

Prepara tus preguntas

Qué evalúan los investigadores

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

Medidas principales

Proportion of patients with objective response (OR)

Plazo: Up to 51 months

according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 by central independent review, and it will be summarised descriptively as absolute and relative frequencies

Medidas secundarias

Duration of objective response (DOR)

Plazo: Up to 51 months

Duration of objective response (DOR) is defined as the time from first documented Objective response (OR) according to RECIST 1.1 until the earliest date of disease progression or death among patients with confirmed OR, assessed by central independent review.

Progression-Free Survival (PFS)

Plazo: Up to 51 months

PFS is defined as the time from treatment start until the earliest date of tumour progression according to RECIST 1.1 assessed by central independent review, or death from any cause, whichever occurs first.

Disease control (DC)

Plazo: Up to 51 months

Disease control (DC) is defined as best overall response (BOR) of complete response (CR) or partial response (PR) or stable disease (SD) where BOR is defined according to RECIST 1.1 from first treatment administration until the earliest of disease progression, death, or last evaluable tumour assessment before the start of subsequent anti-cancer therapy, or treatment discontinuation, as assessed by central independent review.

Occurrence of treatment-emergent Adverse Events (AEs)

Plazo: Up to 51 months

No informado en este registro.

Change from baseline to Week 48 or progressive disease (PD) by central independent review, if earlier, of the EORTC QLQ-C30, which includes IL-19, the physical functioning scale

Plazo: At baseline and up to 48 weeks

QLQ-C30 incorporates both multi-items scales and single-item measures. These include 1 global health status/QoL scale, 5 functional scales, 3 symptoms scales and 6 single items to assess dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. European Organisation for Research and Treatment of Cancer, quality-of-life questionnaire (EORTC QLQ-C30) does not produce a single overall summary score by default. Scores can be reported via domain-specific scores or summary score (since 2016) ranging from 0 to 100 with higher scores representing a better QoL.

Overall survival (OS)

Plazo: Up to 51 months

OR is defined as the time from start of treatment to death from any cause

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

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Centros de investigación (93)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

Buscar un centro en este estudio

93 centros

Alaska Oncology and Hematology, LLCAnchorage, Alaska, United StatesReclutando

Boehringer IngelheimCONTACTunitedstates@bitrialsupport.com 833-602-2368

De qué trata este estudio

Acerca de la investigación

¿Quién podría participar?

Tratamiento, grupos y participación

Qué evalúan los investigadores

Medidas principales

Medidas secundarias

Centros de investigación (93)

Equipo y fechas

Contactos oficiales del estudio

Consulta a Wellness Clinical Research