TORL123-004 CATALINA-4 - Clinical Trial

¿Cuál es el Propósito de este estudio?

People in this study may get up to 8 treatment cycles. Each cycle lasts 21 days. Usually, there are 3 to 4 cycles before surgery and 2 to 4 cycles after surgery, depending on how the cancer responds and what the doctor decides. The whole treatment takes about 8 months, and doctors will check on patients for up to 15 more months. This means the study lasts about 24 months in total.

Doctors will place patients into one of three groups (A, B, or C). This is not random. All groups will get a medicine called TORL 123.

Group A: TORL 123 plus paclitaxel

Group B: TORL 123 plus carboplatin

Group C: TORL 123 plus both paclitaxel and carboplatin

Medicine is given through an IV on Day 1 of each cycle. There will also be extra visits and blood tests during the cycle.

¿Cuál es la Condición que se está estudiando?

Women who have just been diagnosed with ovarian cancer can join this study. This includes cancer in the fallopian tubes or the lining of the belly (called primary peritoneal cancer). They must be able to have chemotherapy and surgery as part of their treatment.

¿Quién puede participar en el Estudio?

To join this study, women must have newly diagnosed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. The tumor must test positive for something called Claudin 6 (CLDN6). Doctors can use tissue from an earlier biopsy or may need to do a new one. Patients must have healthy blood counts and organs. Doctors will check blood often, and treatment may be paused if counts are too low.

Grupo etario
Adultos

¿Qué Implica?

This study is trying to find out if adding a new medicine called TORL 123 to regular chemotherapy can help people with newly diagnosed ovarian cancer do better than using chemotherapy alone.

Detalles del Estudio

Título Completo
Catalina-4: Phase 1b/2 Study of Torl-1-23 with Neoadjuvant Chemotherapy and Interval Cytoreductive Surgery in Newly Diagnosed Patients with Advanced Stage Ovarian Cancer
Investigador Principal
Angeles Alvarez Secord, MD, MHSc
Especialista en oncología ginecológica
Número de Protocolo
IRB: PRO00119316
NCT: NCT07322094
Fase
Phase I/II
ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción
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Contribuya a Duke Health