TORL123-002 / CATALINA-2 (Gynecologic Cancers) - Clinical Trial

¿Cuál es el Propósito de este estudio?

We are doing this study to find out if an experimental drug called TORL-1-23 (the study drug) is a safe and effective option for women who have advanced ovarian cancer, primary peritoneal, or fallopian tube cancer.

¿Cuál es la Condición que se está estudiando?

Cáncer de ovario, primario peritoneal o de trompas de Falopio

¿Quién puede participar en el Estudio?

Who ages 18+ who:

Are diagnosed with one of the following types of cancer: high grade serous or endometrioid ovarian, primary peritoneal (of primary origin), or fallopian tube cancer
Have disease that is advanced (cannot be removed surgically) or metastatic (has spread)
Have a tumor that is positive for CLDN6 expression
Have received at least 1 but not more than 3 previous lines of therapy
Are resistant to platinum-based chemotherapy

For more information, contact the study team at william.s.andrews@duke.edu.

Grupo etario

Adultos

¿Qué Implica?

If you choose to join this study, you will get a random assignment (by chance) to 1 of 3 different groups. Depending on your assignment, you will either:

Arm 1: If you are in this group, you will get a lower dose (2.4 mg/kg) of the study drug + another drug called pegfilgrastim (a medication that helps your body produce a type of white blood cell); OR
Arm 2: If you are in this group, you will get a medium dose (3.0 mg/kg) of the study drug + pegfilgrastim; OR
Arm 3: If you are in this group, you will get a higher dose (3.4 mg/kg) of the study drug + pegfilgrastim

Detalles del Estudio

Título Completo

CATALINA-2: A Phase 2 Study Evaluating the Efficacy and Safety of TORL-1-23 in Women With Advanced Platinum-Resistant Epithelial Ovarian Cancer (Including Primary Peritoneal and Fallopian Tube Cancers) Expressing Claudin 6

Investigador Principal