Table of contents
Trial overview
The available trial is CATALINA-2, a Phase 2 study of HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST CLDN6 CONJUGATED TO MONOMETHYL AURISTATIN E VIA A CATHEPSIN HYDROLYSABLE DIPEPTIDE VC LINKER in advanced ovarian cancer.[1]
The study is authorised and is listed as an interventional trial, which means researchers are giving a treatment and measuring the results.[1]
Who can participate
This trial is for women with advanced ovarian cancer, fallopian tube cancer, or peritoneal cancer.[1]
The brief summary says the study is for women with advanced disease that expresses CLDN6, which is a marker found on some cancer cells.[1]
Study design and phase
This is a Phase 2 trial, so it is designed to look more closely at how well the treatment works in this patient group.[1]
The enrollment target is 235 participants.[1]
The trial includes PEGFILGRASTIM and TORL-1-23 as listed interventions.[1]
What is being measured
The main outcome is Objective Response Rate (ORR), which means the share of patients whose tumors have a partial or complete response.[1]
Responses are measured using RECIST version 1.1, a standard system for checking tumor size on scans.[1]
The response is also checked by blinded independent central review (BICR), meaning experts review the scans without knowing which treatment the patient received.[1]
Trial summary
In simple terms, this study is testing whether HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST CLDN6 CONJUGATED TO MONOMETHYL AURISTATIN E VIA A CATHEPSIN HYDROLYSABLE DIPEPTIDE VC LINKER can help women with advanced CLDN6-positive ovarian, fallopian tube, or peritoneal cancer.[1]
The trial focuses on tumor response and is still in a mid-stage research phase.[1]
