A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRα)

Overview

Información sobre este estudio

The primary purpose of Part 1 (dose escalation) of this study is to establish the MTD and/or RP2D of ELU001 in subjects who have advanced, recurrent or refractory FRα overexpressing tumors considered to be topoisomerase 1 inhibitor-sensitive.

The primary purpose of Part 2 (Tumor Group Expansion Cohorts) of this study is to evaluate anti-tumor activity of ELU001 in subjects who have moderate or high FRα overexpressing tumors considered to be topoisomerase 1 inhibitor-sensitive.

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:

Patients must meet the following criteria to enroll in this study:

- Documented diagnosis of ovarian cancer, endometrial cancer, colorectal cancer, gastric
cancer, gastroesophageal junction cancer, triple negative breast cancer, non-small
cell lung cancer, or cholangiocarcinoma

- No other meaningful life-prolonging therapy option available

- Must provide archival tumor tissue or a newly obtained tumor biopsy specimen prior to
the first dose of ELU001 for folate receptor alpha (FR?) expression analysis

- Adequate organ function

- Measurable disease, or in the absence of measurable disease, non-measurable disease as
per Response evaluation criteria in solid tumors (RECIST) v1.1

- Part 1: Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2;
Part 2: ECOG performance status of 0 or 1.

- Recovered from previous surgeries

- Agree to highly effective contraception, not to get pregnant, or for men, not father a
child during study participation

Key Exclusion Criteria:

Patients who meet any of the following are not eligible to enroll in this study:

- Active or ongoing eye disorders

- Taken any treatments that use the protein folate receptor alpha or FR? to work

- Taken any other experimental treatments

- History of significant cardiac issues or other cancers within 3 years.

- Significant anemia, significant neutropenia, or significant thrombocytopenia (e.g.,
not enough platelets in your blood - platelets held stop bleeding in your body)

- Detectable viral load for HIV (human immunodeficiency virus), hepatitis B or C.

- If you are pregnant.

- Part 1: Cannot have active autoimmune diseases such as rheumatoid arthritis, SLE
(systemic lupus erythematosus), ulcerative colitis, Crohn's Disease, MS (multiple
sclerosis), ankylosing spondylitis, thyroiditis that require treatments that suppress
your immune system.

- Part 1: if your cancer has spread to your brain.

- Part 2: You can have cancer that has spread to your brain but there are exceptions.
The cancer in your brain cannot be causing any symptoms, it cannot be larger than 3
cm, there can be no evidence on a scan that shows your brain tissue has shifted from
its expected position inside the skull (called "herniation") or be bleeding in the
skull or brain itself (called "hemorrhage").

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 6/27/23. 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

Andrea Wahner Hendrickson, M.D.

Abierto para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Gerardo Colon-Otero, M.D.

Abierto para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

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

Información adicional de contacto

Formulario de contacto para ensayos sobre cáncer

Teléfono: 855-776-0015 (toll-free)

Preguntas de estudios clínicos para pacientes internacionales