Study of RP-6306 With FOLFIRI in Advanced Solid Tumors

Overview

Información sobre este estudio

The primary purpose of this study is to assess the safety and tolerability of RP-6306 with FOLFIRI in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD), identify a recommended phase 2 dose (RP2D) and preferred schedule, and assess preliminary anti-tumor activity.

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:

- Male or female and ≥18 years-of-age at the time of signature of the informed consent

- Confirmed advanced solid tumors resistant or refractory to standard treatment

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

- All patients must have locally advanced or metastatic CRC, GI, or esophageal cancer(s)
and radiographic evidence of progressing disease.

- Measurable disease as per RECIST v1.1

- Submission of available tumor tissue or willingness to have a biopsy performed if safe
and feasible

- Acceptable hematologic and organ function at screening

- Negative pregnancy test for women of childbearing potential at Screening and prior to
first study drug.

Exclusion Criteria:

- Inability to swallow and retain oral medications.

- Chemotherapy or small molecule antineoplastic agent given within 21 days or <5 half-
lives, whichever is shorter, prior to first dose of study treatment.

- History or current condition, therapy, or laboratory abnormality that might confound
the study results, or interfere with the patient's participation for the full duration
of the study treatment.

- Patients who are pregnant or breastfeeding

- Life-threatening illness, medical condition, active uncontrolled infection, or organ
system dysfunction or other reasons which, in the investigator's opinion, could
compromise the participating patient's safety.

- Major surgery within 4 weeks prior to first study treatment dose.

- Uncontrolled, symptomatic brain metastases.

- Uncontrolled high blood pressure

- Active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B
virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV), or
acquired immunodeficiency syndrome (AIDS) related illness.

- Moderate or severe hepatic impairment

- Cardiac diseases currently or within the last 6 months as defined by New York Heart
Association (NYHA) ≥Class 2

- Psychological, familial, sociological, or geographical conditions that do not permit
compliance with the protocol and/or follow-up procedures outlined in the protocol.

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

Zhaohui Jin, M.D.

Comunícate con nosotros para obtener el estatus más reciente

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Tanios Bekaii-Saab, M.D.

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