AuthorisedPhase I and Phase II (Integrated)- First administration to humansInterventional

REGENOVAR: A Phase I/II Study of Ubamatamab Plus Carboplatin, Paclitaxel, and Bevacizumab as Salvage Therapy in Ovarian Cancer with Poor Response to First-Line Chemotherapy.

This research study, called REGENOVAR, is investigating a new treatment approach for women with ovarian cancer. It's for those whose cancer hasn't responded as expected to their first round of chemotherapy, or when surgery couldn't remove all the cancer. The study combines a new drug called Ubamatamab with existing treatments (Carboplatin, Paclitaxel, and Bevacizumab). Researchers are carefully monitoring for any side effects and trying to find the safest and most effective dose of Ubamatamab when given with these other medicines. They will also be measuring how much the cancer shrinks or stops growing with this new combination. This is a Phase I/II study, which means it's an early stage of testing in humans, focusing on safety and initial effectiveness.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Asso De Recherche Cancers Gynecologiques

Enrolment target

Start

04 Jun 2026

Patients with poor prognostic ovarian cancers based on the tumor primary chemonsensitivity and incomplete debulking surgery.

What is this study about?

This study is called REGENOVAR and it's looking into a new way to treat ovarian cancer that hasn't responded well to earlier treatments. This might be because the first chemotherapy didn't work as hoped, or if during surgery, not all of the cancer could be removed.

The research combines a new medicine, Ubamatamab, with some standard treatments you might already know: Carboplatin, Paclitaxel, and Bevacizumab. The main goals are to make sure this new combination is safe, to find the best dose of Ubamatamab to use, and to see if it helps shrink the cancer or stop it from growing. Researchers will carefully watch for any side effects and how patients respond to the treatment.

This is an early-stage study, meaning it's among the first times this specific combination is being tested in people. The hope is that this new approach could offer a valuable new treatment option for women with ovarian cancer who have limited choices after their initial therapy.

Key takeaways

This study evaluates a new treatment combination for ovarian cancer that hasn't responded well to initial therapies.
It combines a new drug (Ubamatamab) with existing chemotherapy and anti-cancer medicines.
The main goals are to find a safe dose and see how well it shrinks cancer.
The study is for adult women whose ovarian cancer is challenging to treat.
Participation involves regular appointments, treatments, and close monitoring for side effects and effectiveness.
It's an early-stage study, meaning the treatment is still under investigation.

Who may be eligible?

This study is specifically designed for adult women, aged 18 or older, who have ovarian cancer. It's for those whose cancer has been particularly challenging to treat.

Specifically, you might be eligible if your ovarian cancer didn't respond well to your first chemotherapy treatment. This means the cancer continued to grow or return quickly after your initial treatment. It also includes women who had surgery for their ovarian cancer, but the surgeons weren't able to remove all of the visible cancer at that time.

The medical team will need to review your full health history and specific details about your cancer to confirm if this study is suitable for you. They will explain all the requirements clearly.

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 an adult woman, aged 18 or over?
Do you have ovarian cancer?
Has your ovarian cancer not responded well to your past initial chemotherapy?
Or, was your surgery for ovarian cancer unable to remove all visible cancer?
Are you able to attend regular appointments for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve receiving a combination of medicines: Ubamatamab, Carboplatin, Paclitaxel, and Bevacizumab, along with another medicine called Filgrastim which helps with blood counts. These treatments would be given in cycles. During the study, you'll have regular appointments for check-ups, blood tests, and scans to see how you're responding to the treatment and to monitor for any side effects. Researchers will be especially interested in monitoring your health during the first four weeks of treatment. The exact number of visits and the total duration would be explained by the study team, but it will involve continued follow-up to track your progress and condition.

Potential risks and benefits

Like all medical treatments, there are potential benefits and potential risks to consider. The potential benefit is that this new combination of medicines might help to shrink your cancer or slow its growth, especially if other treatments haven't worked well. However, because Ubamatamab is a new drug in this combination, there's always a chance of side effects, some of which could be serious or unexpected. The research team will explain all known potential side effects. Throughout the study, you have the right to withdraw at any time for any reason, without it affecting your future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
France

Common questions

What is Ubamatamab?

Ubamatamab is a new medicine being tested. It's given alongside other standard chemotherapy drugs to see if it can improve treatment for ovarian cancer.

What does 'poor response to first-line chemotherapy' mean?

It means your ovarian cancer didn't respond as well as doctors hoped to your initial chemotherapy treatment, or it came back quickly after that treatment.

What are 'Phase I' and 'Phase II' studies?

These are early stages of testing new treatments. Phase I focuses on finding a safe dose and understanding side effects, while Phase II starts to look at how well the treatment works.

Will this treatment cure my cancer?

This study aims to find a new, effective treatment for challenging ovarian cancer. While it may help control the cancer, a cure is not guaranteed and success varies for each person.

What if I experience side effects?

The study team will closely monitor you for any side effects and will explain what to do if you feel unwell. Your safety is their top priority.