A Study to Evaluate the Safety and Tolerability of HMPL-306 to Treat Advanced or Metastatic Solid Tumors with IDH Mutations

Overview

Información sobre este estudio

The purpose of this study is to evaluate the safety, tolerability, and preliminary effectiveness of HMPL-306 in advanced or metastatic solid tumors with IDH mutation.

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.

Key Inclusion Criteria:

Subjects are eligible for enrollment into this study if they meet any of the following
criteria (NOTE: This is not an exhaustive list):

- Subjects aged ≥18 years.

- ECOG performance status 0 or 1

- Subjects must have a documented IDH mutation per immunohistochemistry (IHC),
polymerase chain reaction (PCR), or next generation sequencing (NGS) testing of tumor
tissue.

- Subjects must have histologically or cytologically documented, advanced or metastatic
solid malignancy of any type that has recurred or progressed on available standard
treatment and for which no curative therapy exists.

Key Exclusion Criteria:

Subjects are not eligible for enrollment into this study if they meet any of the following
criteria (NOTE: This is not an exhaustive list):

- Subjects who received an investigational agent <14 days prior to their first day of
study drug administration

- Subjects who are pregnant or breastfeeding

- Subjects with an active severe infection, some treated infections and with an expected
or with an unexplained fever >38.3°C during screening visits or on their first day of
study drug administration.

- Subjects with some current or prior heart conditions

- Subjects taking medications that are known to prolong the QT interval may not be
eligible

- Subjects with immediately life-threatening, severe complications of leukemia such as
uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated
intravascular coagulation

- Some subjects with some current or prior gastrointestinal or liver diseases

- Subjects with inadequate organ function as defined by the protocol

Eligibility last updated 8/17/22. Questions regarding updates should be directed to the study team contact.

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

Rochester, Minn.

Investigador principal de Mayo Clinic

Sani Kizilbash, M.D., M.P.H.

Comunícate con nosotros para obtener el estatus más reciente

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publicaciones

Publications are currently not available

Información adicional de contacto

Formulario de contacto para ensayos sobre cáncer

Teléfono: 855-776-0015 (toll-free)

Preguntas de estudios clínicos para pacientes internacionales