Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A Phase 1 Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of STRO-002, an Anti-Folate Receptor alpha (FolRα) Antibody Drug Conjugate (ADC), in Combination with Bevacizumab in Patients with Advanced Epithelial Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers)

This study, called "Human Pharmacology (Phase I)", is looking at a new medicine for advanced ovarian cancer, including cancers of the fallopian tube or the lining of the abdomen (primary peritoneal cancer). The new medicine is called STRO-002, and it’s given together with bevacizumab, a medicine already used for some cancers. The main goals are to check if this new combination is safe for people, how it moves through and leaves the body, and to get an early idea if it might help treat the cancer. This is one of the very first times this combination is being given to people, so researchers will be carefully monitoring participants. It's for adult women aged 18 and over.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Sutro Biopharma Inc.

Enrolment target

Start

04 Nov 2024

Advanced Epithelial Ovarian Cancer (including Fallopian Tube or Primary Peritoneal cancers)

What is this study about?

This study is a Phase 1 clinical trial, which means it's one of the first times a new treatment is being given to people. The main purpose of this phase is to check the safety of the new medicine and see how it behaves in the human body. Researchers also want to get an early idea of whether it might be effective against cancer. This particular study is looking at a new drug called STRO-002, which works by targeting a specific protein often found on ovarian cancer cells. It's given alongside another medicine called bevacizumab, which is already used to treat certain cancers.

The study is for women who have advanced ovarian cancer, which includes cancers that start in the fallopian tubes or the lining of the abdomen (primary peritoneal cancers). Advanced cancer means it has spread from where it started. Doctors are always looking for better ways to treat these cancers, and this study is a step towards finding new options.

By taking part, you would be helping doctors learn more about this new medicine combination. Your safety and well-being would be carefully monitored throughout the study. The information gathered will be vital for deciding if this treatment should be tested in more people in the future.

Key takeaways

It's an early-stage (Phase 1) study for advanced ovarian, fallopian tube, or primary peritoneal cancers.
It's testing a new medicine (STRO-002) with an existing one (bevacizumab).
The main goals are to check safety and how the medicines work in the body.
It's for women aged 18 and over.
Participation involves regular clinic visits and close monitoring.
You can stop participating at any time.

Who may be eligible?

This study is designed for specific patients. To be considered, you must be a woman aged 18 years or older. There is no upper age limit, meaning older adults can also participate if they meet all other criteria.

You must have been diagnosed with advanced epithelial ovarian cancer. This includes similar cancers that start in the fallopian tube or the lining of your abdomen, known as primary peritoneal cancer.

Beyond these basic requirements, the research team will check other health details to make sure the study is a safe and suitable option for you. They will look at things like your general health, any other medical conditions you might have, and previous treatments you've received. These checks are important to ensure your safety during the 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 18 years old or older?
Are you female?
Have you been diagnosed with advanced epithelial ovarian cancer (or fallopian tube/primary peritoneal cancer)?
Are you able to attend regular clinic appointments as required by the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the investigational new medicine, STRO-002, along with bevacizumab, as directed by the study doctors. You would have regular appointments at the study clinic where the medical team will closely monitor your health, check for any side effects, and see how the treatment is affecting your cancer.

These appointments will involve various health checks, which might include blood tests, physical examinations, and scans to assess your cancer. The frequency and type of these visits will be explained to you in detail. The total duration of your participation will vary depending on how you respond to the treatment and what the doctors recommend, but you would be fully informed about the expected commitment. After the treatment period, there will be follow-up appointments to continue monitoring your health.

Potential risks and benefits

Taking part in a clinical trial might offer the potential benefit of accessing a new treatment that isn't widely available yet, which could help your condition. However, there are also potential risks; medicines can have side effects, and in a Phase 1 study, the full range of side effects of a new combination might not be completely known. The study team will explain all known risks and monitor you closely for any unwanted effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
France
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Unverified
Italy
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Unverified
Spain

Common questions

What does 'Phase 1' mean for this study?

Phase 1 means this is one of the first times this new treatment combination is being given to people. The main focus is to check its safety and how it works in the body.

What kind of cancer is this study for?

This study is specifically for advanced epithelial ovarian cancer. This also includes similar cancers that start in the fallopian tube or the lining of the abdomen (primary peritoneal cancer).

What are the medicines being tested?

The study is testing a new medicine called STRO-002, given together with another medicine called bevacizumab. Bevacizumab is already used for some cancers.

Will this new treatment cure my cancer?

While the aim is to find effective new treatments, this is a very early study (Phase 1). It's focused on learning about safety and how the drug works, rather than a guarantee of a cure. Any potential benefits will be discussed by your doctor.

What if I decide I don't want to continue in the study?

You are free to leave the study at any time, for any reason, without it affecting your future medical care. You just need to inform the study team.