RecruitingPHASE2INTERVENTIONAL

A Study of Lorigerlimab in Participants With Advanced Solid Tumors

This study is looking at a new drug called lorigerlimab for women with certain types of advanced ovarian cancer, or other gynaecological cancers like womb, fallopian tube, cervical, or vaginal cancers, especially if they haven't responded to previous platinum-based chemotherapy. If you have clear cell gynaecological cancer, this study might also be an option. The main goals are to find out if lorigerlimab is safe to use and if it can help stop the cancer from growing or even shrink it. Participants will receive the medicine directly into their bloodstream every three weeks, and doctors will carefully monitor them for side effects and how their cancer responds.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

MacroGenics

Enrolment target

Start

01 May 2025

Estimated completion

01 Dec 2027

Platinum-resistant Ovarian Cancer Platinum-Resistant Fallopian Tube Carcinoma Platinum-Resistant Primary Peritoneal Carcinoma Clear Cell Adenocarcinoma of Ovary Clear Cell Adenocarcinoma of Vulva Clear Cell Adenocarcinoma of Vagina Clear Cell Adenocarcinoma of Cervix Clear Cell Adenocarcinoma of Uterus Clear Cell Adenocarcinoma of Fallopian Tube Clear Cell Adenocarcinoma of Peritoneum Endometrial Cancer

What is this study about?

This study is called "A Study of Lorigerlimab in Participants With Advanced Solid Tumors." It's designed for women who have certain types of advanced cancer affecting the ovaries, fallopian tubes, or the lining of the belly (peritoneum). It also includes women with specific clear cell cancers in areas like the ovary, womb, vagina, vulva, or cervix. The key here is that these cancers have either come back or not responded well to platinum-based chemotherapy, a common treatment.

Researchers want to see if a new medicine, lorigerlimab, can help in these situations. Lorigerlimab is given directly into a vein. The medical team will carefully watch how participants' bodies react to the treatment, looking for any side effects and regularly checking to see how the cancer is responding. This is a "Phase 2" study, which means it's one of the earlier stages where doctors are still learning about the drug's effectiveness and safety in a larger group of people.

The ultimate goal of this research is to find new and more effective ways to treat these challenging cancers. By taking part, you could help doctors understand more about lorigerlimab, which might lead to better treatment options for other patients in the future.

Key takeaways

This study is testing a new medicine, lorigerlimab, for specific advanced gynaecological cancers.
It's for women whose cancers haven't responded well to previous 'platinum-based' treatments, or those with clear cell gynaecological cancer.
Treatment is given as an intravenous drip every three weeks.
Doctors will closely monitor participants for side effects and how their cancer responds.
The aim is to find out if the drug is safe and effective in shrinking or controlling the cancer.
Participation could help develop future treatments for other patients.

Who may be eligible?

To join this study, you would need to be a woman aged 18 or over. You would also need to have certain advanced gynaecological cancers that have either struggled with, or come back after, previous platinum-based chemotherapy. This includes specific types of ovarian, fallopian tube, or peritoneal cancer, or clear cell cancers in the ovary, womb, vagina, vulva, or cervix.

You would also need to have received a certain number of previous treatments for your cancer (between one and three lines for platinum-resistant ovarian cancer, or at least one line for clear cell gynaecological cancer). If you have a specific BRCA gene change, you would generally need to have tried a PARP inhibitor medicine already, if it was available to you. Your doctors would need to be able to measure your cancer, and you'd need to provide a tissue sample from your cancer, either an old one or a new one taken during the study.

There are also some reasons why you might not be able to join. For example, if your cancer didn't respond to your very first platinum-based chemotherapy, or if you've already had certain types of immunotherapy treatment in the past. You also can't be pregnant, planning a pregnancy, or breastfeeding. Your overall health needs to be good enough to take part.

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 older?
Do you have advanced ovarian, fallopian tube, peritoneal, or clear cell gynaecological cancer?
Has your cancer progressed after or not responded well to certain previous treatments?
Do you have at least one measurable area of cancer?
Are you able to provide a tissue sample of your cancer?
Are you not pregnant, planning to be pregnant, or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicine, lorigerlimab, as a drip directly into your vein. This treatment would happen on the first day of every three-week cycle. You would continue to receive treatment for as long as it's helping and not causing too many side effects, or until the study finishes.

Throughout the study, the medical team will keep a close eye on you. This includes regular physical check-ups and blood tests every three weeks to monitor your health and any side effects. Your cancer will be checked with scans roughly every nine weeks for the first year, and then every 12 weeks after that, to see how it's responding to the treatment. If you stop the treatment for any reason, you'll have a follow-up safety check within 30 days. If you stop because your cancer has progressed, you'll be followed for six months to check on your survival.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. A potential benefit of this study is that lorigerlimab might help slow down or shrink your cancer, especially if other treatments haven't worked well. However, because it's a new medicine, there might be side effects that doctors don't fully understand yet. Like all medicines given through a drip, there's a risk of feeling unwell, having allergic reactions, or other side effects. You will be closely monitored for any unwanted effects throughout the study. It's important to remember that you can stop taking part in the study at any time, for any reason, without it affecting your usual medical care.

Locations (16)

UCLA
Verified postcode
Los Angeles, United States· Recruiting
Ochsner MD Anderson Cancer Center
Verified postcode
New Orleans, United States· Recruiting
START Midwest
Verified postcode
Grand Rapids, United States· Recruiting
West Penn Allegheny Health
Verified postcode
Pittsburgh, United States· Recruiting
The University of Texas MD Anderson Cancer Center, Gynecologic Oncology Center
Verified postcode
Houston, United States· Recruiting
START San Antonio
Verified postcode
San Antonio, United States· Recruiting
Wisconsin Institute Medical Research- UW Cancer Connect
Verified postcode
Madison, United States· Recruiting
Princess Margaret Cancer Center
Verified postcode
Toronto, Canada· Recruiting
McGill University
Verified postcode
Montreal, Canada· Recruiting
National Cancer Center
Verified postcode
Goyang-si, South Korea· Recruiting
Seoul National University Hospital Bundang Hospital
Verified postcode
Seongnam-si, South Korea· Recruiting
Yonsei University Health System Severance Hospital
Verified postcode
Seoul, South Korea· Recruiting

Common questions

What is lorigerlimab?

Lorigerlimab is a new investigational medicine being tested in this study to see if it can help treat advanced cancers.

What does 'platinum-resistant' mean?

It means your cancer has either come back or gotten worse after being treated with medicines that contain platinum, which are common cancer drugs.

How will I receive the treatment?

The medicine will be given directly into a vein through a drip on the first day of every three-week cycle.

Will I still get my usual cancer care if I join?

Yes, you can leave the study at any time, for any reason, and it won't affect your access to standard care.

How long will the study last for me?

You will continue treatment as long as it's helping and you're not having bad side effects, or until the study finishes. Your follow-up will continue after treatment stops.

How to find out more

Global Trial Manager

info@macrogenics.com 301-251-5172 Official trial record

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