RecruitingPHASE2INTERVENTIONAL

CATALINA-2: A Clinical Study of TORL-1-23 in Platinum-resistant Ovarian Cancer.

The CATALINA-2 study is looking into a new treatment, TORL-1-23, for women who have advanced ovarian, primary peritoneal, or fallopian tube cancer. Specifically, it's for those whose cancer has returned or progressed after platinum-based chemotherapy, meaning it's considered 'platinum-resistant'. This Phase 2 study aims to find out if TORL-1-23 is a safe and effective option. Researchers will also check if the cancer cells have a specific marker called CLDN6, as the new drug is designed to target this. The study is for women aged 18 and over who have received a limited number of previous cancer treatments.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

TORL Biotherapeutics, LLC

Enrolment target

230

Start

20 Nov 2024

Estimated completion

01 Dec 2027

Epithelial Ovarian Cancer Primary Peritoneal Fallopian Tube Cancer Endometrioid Ovarian Cancer

What is this study about?

The CATALINA-2 study is a research project focusing on a new medicine called TORL-1-23. It's designed for women who have certain types of advanced cancer, specifically ovarian, primary peritoneal, or fallopian tube cancer. These cancers can sometimes become resistant to common chemotherapy drugs that contain platinum. When this happens, it means the cancer has stopped responding to those treatments, which can be very challenging.

The main goal of this study is to see how well TORL-1-23 works and if it's safe for people with these specific cancers. Researchers want to understand if this new drug can help slow down or stop the cancer from growing. They are also checking to see if the cancer cells have a particular feature called CLDN6, because TORL-1-23 is designed to target cells that have this marker.

Taking part in a study like this helps doctors learn more about new treatments. The information gathered from participants can help improve care for future patients. It's an important step in developing new ways to fight cancer, especially when standard treatments are no longer effective.

Key takeaways

This study is for women with advanced ovarian, primary peritoneal, or fallopian tube cancer.
Your cancer must be 'platinum-resistant' (not responding well to platinum chemotherapy).
A new drug called TORL-1-23 is being tested.
Your cancer cells need to have a marker called CLDN6.
You should have had 1 to 3 previous cancer treatments.
The study aims to check the safety and effectiveness of TORL-1-23.

Who may be eligible?

This study is for women aged 18 or older. You must have advanced ovarian, primary peritoneal, or fallopian tube cancer that has been diagnosed by looking at tissue samples under a microscope. This includes a type called high-grade endometrioid ovarian cancer.

Your cancer must be considered 'platinum-resistant'. This means it has either grown again or worsened within 6 months after receiving platinum-based chemotherapy. If you've had only one platinum treatment, it must have progressed between 3 and 6 months after your last dose. Importantly, your cancer cells need to show a specific marker called CLDN6 for you to be eligible.

You should have had at least one, but no more than three, previous courses of systemic cancer treatment (like chemotherapy or targeted therapy). However, if your cancer didn't respond to front-line platinum treatment at all, you would not be able to join this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman aged 18 or over?
Do you have advanced ovarian, primary peritoneal, or fallopian tube cancer?
Has your cancer been confirmed as 'platinum-resistant'?
Has your cancer been tested and shown to have the CLDN6 marker?
Have you had at least 1 but no more than 3 previous lines of cancer treatment?
Are you able to attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new drug TORL-1-23. You might also receive a drug called Pegfilgrastim, which helps support your blood counts during cancer treatment. Before you start, a tissue sample of your tumour will be checked to confirm it has the CLDN6 marker.

The exact schedule of visits and assessments will be explained by the study team, but typically involves regular hospital appointments for receiving the medication, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. There will also be follow-up appointments to track your progress.

The total duration of your participation in the study will depend on how you respond to the treatment and your health, but it could last for a number of months.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as gaining access to a new treatment that isn't widely available yet, which might help control your cancer. However, treatment with any new medicine comes with potential risks and side effects, some of which may be unknown. The study team will explain all known side effects and monitor you very closely. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (66)

Mayo Clinic Hospital
Verified postcode
Phoenix, United States· Recruiting
SCRI - Arizona Oncology Associates, PC-HOPE
Verified postcode
Tucson, United States· Recruiting
City of Hope National Medical Center
Verified postcode
Duarte, United States· Recruiting
Providence St. Jude Medical Center
Verified postcode
Fullerton, United States· Recruiting
UCLA - JCCC Clinical Research Unit
Verified postcode
Los Angeles, United States· Recruiting
Stanford Cancer Center
Verified postcode
Palo Alto, United States· Recruiting
SCRI - Sansum Clinic
Verified postcode
Santa Barbara, United States· Recruiting
Smilow Cancer Hospital at Yale - New Haven
Verified postcode
New Haven, United States· Recruiting
Mayo Clinic Florida
Verified postcode
Jacksonville, United States· Recruiting
Winship Cancer Institute, Emory University
Verified postcode
Atlanta, United States· Recruiting
University of Chicago Medical Center
Verified postcode
Chicago, United States· Recruiting
SCRI - Maryland Oncology Hematology, P.A.
Verified postcode
Annapolis, United States· Recruiting

Common questions

What does 'platinum-resistant ovarian cancer' mean?

It means your ovarian cancer has started to grow again or worsen within 6 months after you finished a chemotherapy that contained platinum medicine.

What is TORL-1-23?

TORL-1-23 is a new investigational drug being tested in this study to see if it can help treat advanced ovarian, primary peritoneal, or fallopian tube cancer.

What is CLDN6?

CLDN6 is a specific marker that needs to be present on your cancer cells for you to be eligible for this study, as the new drug TORL-1-23 is designed to target it.

Will I get side effects from the treatment?

Like all medicines, TORL-1-23 may cause side effects. The study team will discuss potential side effects with you and monitor you closely if you participate.

Can I leave the study at any time?

Yes, you are free to leave the study at any point without it affecting your medical care.

How to find out more

Hatem Dokainish, PhD

catalina-2-study@torlbio.com 310-348-9636 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.