Catalina-2 (ENGOT-ov83)

About this trial

Abnormal expression of CLDN6 has been observed in a variety of cancers, whereas little to no CLDN6 is found in normal, healthy
tissues. This high expression of CLDN6 in cancer cells relative to normal tissues makes it an attractive target for the development of drugs that selectively act against cancer cells.

The study drug, TORL-1-23 is a targeted antibody–drug conjugate (ADC) that binds specifically and strongly to CLDN6. Data from ongoing studies of TORL-1-23 in participants with advanced cancers indicate that the drug is generally well-tolerated and may have antitumor activity in tumors expressing CLDN6.

This Phase 2 study has been designed to further evaluate the safety, tolerability, and efficacy of TORL-1-23 in women with platinum-resistant ovarian cancer (PROC) whose tumors express CLDN6.

Patient Profile

* confirmed diagnosis of advanced (unresectable) or metastatic high grade serous ovarian, primary peritoneal (ie, of primary origin), or
fallopian tube cancer that resistant to platinum-containing therapy
* Participant’s tumor must show CLDN6 expression.
* Have measurable tumor at baseline

Where’s this trial being run?

St James’s Hospital and Mater Misericordiae University Hospital

Can I join this study / trial?

The first step we recommend is to talk to your doctor or the cancer trials team at your hospital. You can find contact details for cancer trials research units in Ireland here.

It’s also a good idea to print this page and bring it with you to your appointment. It can help guide the conversation and remind you of what to ask. You may also want to talk to your family or friends about your options, as they can offer support as you make decisions.

For more detailed information

Click Here

Questions?

Here’s a list of questions you may have for your doctor or local cancer research team.

Questions

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Summary Data

Name:	Catalina-2 (ENGOT-ov83)
Number:	24-68
Full Title:	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

Principal Investigator:	Prof Austin Duffy (START, MMUH)
Type:	Industry Sponsored
Sponsor:	TORL BioTherapeutics LLC
Recruitment Started:	Global: Nov 2024 Ireland: Sep 2025

Global Recruitment Target:	230
Ireland Recruitment Target:	17