RecruitingPHASE3INTERVENTIONAL

A Study to Investigate Mocertatug Rezetecan Compared With Standard of Care in Participants With Platinum-resistant Ovarian Cancer (BEHOLD-Ovarian01)

This study, named BEHOLD-Ovarian01, is exploring a new treatment called Mocertatug Rezetecan, or Mo-Rez for short. It's designed for women who have ovarian cancer that has become resistant to standard platinum-based chemotherapy. The main goal is to compare how well Mo-Rez works against other established treatments, like paclitaxel or pegylated liposomal doxorubicin, that are currently used. Researchers will also be carefully checking for any side effects and how well patients tolerate the new medicine. This is a Phase 3 study, which means it's a large, important step in determining if Mo-Rez could become a new option for patients. Your doctors will explain if this study might be suitable for you.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

GlaxoSmithKline

Enrolment target

450

Start

18 Jun 2026

Estimated completion

22 Jul 2030

Ovarian Neoplasms

What is this study about?

This study is investigating a new treatment for ovarian cancer called Mocertatug Rezetecan (we'll call it Mo-Rez for short). It's designed specifically for women whose ovarian cancer has stopped responding effectively to platinum-based chemotherapy, which is a common type of treatment. In these situations, doctors look for new ways to help patients.

The main aim of this study is to see if Mo-Rez is more effective than the standard treatments currently available for this type of ovarian cancer. Researchers will compare how well patients respond to Mo-Rez versus established medicines. They will also carefully monitor any side effects to understand if Mo-Rez is safe and easy for patients to tolerate. This information is really important because it helps doctors understand if a new medicine can offer a better option for people with specific types of cancer.

This is a 'Phase 3' study, which is usually the last big step before a new medicine might be considered for wider use. It means many patients will be involved, and the results will help show if Mo-Rez could become a valuable new treatment choice for women with platinum-resistant ovarian cancer.

Key takeaways

This study is testing a new medicine, Mo-Rez, for certain ovarian cancers that no longer respond well to platinum treatments.
It aims to see if Mo-Rez is more effective and safer than current standard treatments.
You must have platinum-resistant ovarian cancer of a specific type and have had 1-4 prior treatments.
Participation involves receiving either the new medicine or a standard treatment, with regular medical check-ups.
You'll be closely monitored for treatment effectiveness and any side effects.
You can stop participating at any time without affecting your usual medical care.

Who may be eligible?

To join this study, you need to be at least 18 years old.

The study is for women with a specific type of ovarian cancer, including cancer that started in the fallopian tube or the lining of the tummy (peritoneum). Your cancer must be of a certain type (like high-grade serous, high-grade endometrioid, clear cell carcinoma, or carcinosarcoma) and have become resistant to platinum-based chemotherapy. This means your cancer has started to grow again within a certain time frame after receiving platinum-based treatment, showing that the treatment is no longer as effective. Also, your cancer cells need to show a particular marker called 'folate receptor alpha' to be considered.

You should have already received at least one, but no more than four, previous lines of cancer treatment. Your doctor will carefully check your full treatment history to see if it matches the study requirements, including if you've had specific prior treatments like mirvetuximab soravtansine.

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 18 years old or older?
Do you have ovarian cancer (including fallopian tube or peritoneal) that is resistant to platinum chemotherapy?
Have you had at least 1, but no more than 4, previous cancer treatments?
Does your cancer have a marker called 'folate receptor alpha'?
Have you had specific prior treatments like Mirvetuximab soravtansine, or is there a medical reason you couldn't have them?

Answer every question to see your result.

What does participation involve?

If you join this study, you will either receive the new medicine, Mocertatug Rezetecan, or one of the standard treatments currently used for your condition. You won't get to choose which treatment you receive; this is decided randomly, like flipping a coin, to ensure the comparison is fair. The treatment will be given on a regular schedule, likely through infusions (drips) in a hospital or clinic.

You'll have regular hospital visits for check-ups, blood tests, scans (like CT or MRI), and to discuss any side effects you might be experiencing. The medical team will closely monitor your health and how well the treatment is working. The study involves a treatment period, and then a follow-up period to continue checking on your health and how you're doing. The exact number of visits, tests, and the total duration will vary depending on your treatment plan and how you respond, but the study team will explain everything in detail.

Potential risks and benefits

Taking part in a clinical trial might offer benefits such as access to a new treatment before it's widely available, and you'll receive very close medical monitoring. The information gathered also helps other patients in the future. However, there are potential risks, as new medicines can have side effects that aren't fully known, and the treatment might not work for everyone. Standard treatments also have known side effects. All possible side effects will be carefully explained to you by the study team. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (22)

GSK Investigational Site
Verified postcode
Randwick, Australia· Recruiting
GSK Investigational Site
Verified postcode
Auchenflower, Australia· Recruiting
GSK Investigational Site
Verified postcode
Toronto, Canada· Recruiting
GSK Investigational Site
Verified postcode
Montreal, Canada· Recruiting
GSK Investigational Site
Verified postcode
Montreal, Canada· Recruiting
GSK Investigational Site
Verified postcode
Fukuoka, Japan· Recruiting
GSK Investigational Site
Verified postcode
Fukuoka, Japan· Recruiting
GSK Investigational Site
Unverified
Hokkaido, Japan· Recruiting
GSK Investigational Site
Verified postcode
Hyōgo, Japan· Recruiting
GSK Investigational Site
Verified postcode
Kanagawa, Japan· Recruiting
GSK Investigational Site
Verified postcode
Kanagawa, Japan· Recruiting
GSK Investigational Site
Verified postcode
Mie, Japan· Recruiting

Common questions

What is Mocertatug Rezetecan (Mo-Rez)?

Mo-Rez is a new medicine being studied to treat certain types of ovarian cancer. It's not yet widely available, which is why it's being tested in this clinical trial.

What does 'platinum-resistant' ovarian cancer mean?

It means your ovarian cancer has started to grow again within a certain time after you finished platinum-based chemotherapy. This shows the cancer is no longer responding well to that type of treatment.

Why can't I choose which treatment I get?

To fairly compare the new medicine with standard treatments, it's decided randomly (like by chance) who gets which treatment. This helps researchers understand if the new medicine is truly better.

Will I still receive my usual care if I join?

Yes, you will continue to receive excellent medical care throughout the study. Your health and wellbeing are the top priority for the study team.

What happens if I change my mind about participating?

You are free to withdraw from the study at any time, for any reason. Your decision will not affect your ongoing medical care or relationship with your doctors.

How to find out more

US GSK Clinical Trials Call Center

gskclinicalsupporthd@gsk.com 877-379-3718 Official trial record

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