A Study to Evaluate Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy for HER2+ Gastrointestinal Cancers

Overview

Información sobre este estudio

The purpose of this study is to determine the recommended dose of tucatinib when combined with trastuzumab and modified FOLFOX7 (mFOLFOX7) or CAPOX in subjects with human epidermal growth factor receptor 2 (HER2)+ gastrointestinal cancers.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

- Participants must have an unresectable or metastatic solid malignancy that is
histologically or cytologically confirmed to be one of the tumor types listed below:

- Cohorts 1A, 1B, 1C, and 1D

- CRC

- Gastric adenocarcinoma

- GEJ adenocarcinoma

- Esophageal adenocarcinoma

- Cholangiocarcinoma

- Gallbladder carcinoma

- Cohorts 1E, 1F, 1G, and 2A

- Gastric adenocarcinoma

- GEJ adenocarcinoma

- Esophageal adenocarcinoma

- Cohort 2B

- CRC

- Participants must be candidates to receive an oxaliplatin-based regimen as part of
their standard-of-care treatment for all cohorts, except Cohort 1G.

- HER2+ disease, as determined by historic or local laboratory testing

- Phase 1b cohorts: measurable or non-measurable disease according to RECIST v1.1 as
determined by the investigator

- Phase 2 cohorts: measurable disease according to RECIST v1.1 as determined by the
investigator

- Eastern Cooperative Oncology Group Performance Status score of 0 or 1.

Exclusion Criteria:

- History of known hypersensitivity to planned study treatment

- Known to be positive for Hepatitis B or C

- For Cohorts 2A and 2B: prior anti-HER2 therapies

- For Cohorts 1E, 1F, 1G, 2A: Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2
agent or with an agent directed to another stimulatory or co-inhibitory T-cell
receptor (eg, CTLA-4, OX 40, CD137), and was discontinued from that treatment due to a
Grade 3 or higher immune-related adverse event (irAE)

There are additional inclusion criteria. The study center will determine if criteria for participations are met.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Tanios Bekaii-Saab, M.D.

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publicaciones

Publications are currently not available
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CLS-20487854

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