In short
Clinical trials are investigating HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST CLDN6 CONJUGATED TO MONOMETHYL AURISTATIN E VIA A CATHEPSIN HYDROLYSABLE DIPEPTIDE VC LINKER in advanced cancers that express CLDN6. The main goal is to see how well it works and to measure safety and response in women with advanced ovarian, fallopian tube, or peritoneal cancer.
Key points
- Clinical trials are studying HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST CLDN6 CONJUGATED TO MONOMETHYL AURISTATIN E VIA A CATHEPSIN HYDROLYSABLE DIPEPTIDE VC LINKER in advanced cancers that express CLDN6. The available trial is a Phase 2 study in women with advanced ovarian, fallopian tube, or peritoneal cancer. The study is authorised and plans to enroll 235 people. Its main goal is to measure Objective Response Rate, which shows how many tumors shrink or disappear. The trial uses RECIST 1.1 and blinded independent central review to judge response.
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.
The study is authorised and is listed as an interventional trial, which means researchers are giving a treatment and measuring the results.
Who can participate
This trial is for women with advanced ovarian cancer, fallopian tube cancer, or peritoneal cancer.
The brief summary says the study is for women with advanced disease that expresses CLDN6, which is a marker found on some cancer cells.
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.
The enrollment target is 235 participants.
The trial includes PEGFILGRASTIM and TORL-1-23 as listed interventions.
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.
Responses are measured using RECIST version 1.1, a standard system for checking tumor size on scans.
The response is also checked by blinded independent central review (BICR), meaning experts review the scans without knowing which treatment the patient received.
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.
The trial focuses on tumor response and is still in a mid-stage research phase.