RecruitingPHASE1INTERVENTIONAL

First-in-human Trial of PhOx430, a First-in-class Acetylglucosaminyltransferase V Inhibitor, in Advanced Solid Tumours

This early-stage study, called the PhAST Trial, is investigating a new drug named PhOx430 for people with advanced solid tumours, which are cancers that have spread or are difficult to treat. These are patients for whom standard treatments are no longer working. The main goals are to find a safe dose of PhOx430 and understand any side effects. It also looks at how the body processes the drug and if it shows any signs of shrinking tumours. The study begins by testing different doses in various tumour types, then focuses on specific cancers like glioblastoma (a type of brain tumour) and triple-negative breast cancer. It's hoped this research will lead to new treatment options for people with these challenging cancers.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Phost'In Therapeutics

Enrolment target

149

Start

18 Jul 2022

Estimated completion

31 Jul 2027

Malignant Tumor Advanced Solid Tumor Glioblastoma Multiforme Metastatic Cancer

What is this study about?

This research study, known as the PhAST Trial, is a very early-stage look at a new drug called PhOx430. Its main purpose is to see if PhOx430 is safe and can be tolerated by people with advanced solid tumours. "Advanced solid tumours" means cancers that have grown or spread in the body, and for which standard treatments are no longer effective or available. This study is funded partly by the Gianni Bonadonna Foundation, a non-profit group dedicated to finding new cancer treatments.

The study has two main parts. The first part, called "dose escalation," involves a small number of patients with various types of solid tumours. The researchers will start with a very low dose of PhOx430 and gradually increase it in different groups of patients. This helps them find the highest dose that is still safe and tolerable, which they'll call the "Maximally Tolerated Dose." They will also keep a close eye on any side effects.

The second part, called "cohort expansion," will use the safe dose found in the first part. This part will enrol more patients but will focus on specific types of advanced cancers, such as glioblastoma (a type of brain tumour) and triple-negative breast cancer. The main goal here is to get a better understanding of the drug's safety and how effectively it might work in these particular cancers. Researchers will also be looking for clues about who might benefit most from this new treatment.

Key takeaways

This is an early-stage study testing a new cancer drug, PhOx430.
It's for people with advanced solid tumours, especially when other treatments haven't worked.
The main goals are to find a safe dose and look for early signs of effectiveness.
It will specifically investigate glioblastoma and triple-negative breast cancer in later stages.
Participation involves regular check-ups, tests, and closely monitoring any side effects.

Who may be eligible?

To be considered for this study, you must have a confirmed diagnosis of cancer that is advanced or has spread (metastatic). This means your condition has worsened despite previous treatments, and there are currently no other standard effective treatments for your cancer.

You should be between 18 and 80 years old. Your general health and ability to perform daily activities, measured by something called an ECOG performance status, should be 0 or 1 (meaning you are fully active or mostly active but can perform light work). If you have glioblastoma, a different measure called Karnofsky Performance Status will be used.

Also, any side effects you might still be experiencing from previous treatments must have mostly cleared up. The study also requires that certain levels in your blood, such as blood cell counts and liver/kidney function, are within a healthy range.

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.

Do you have a confirmed diagnosis of advanced or metastatic solid cancer?
Has your cancer progressed despite previous treatments?
Are there no other standard effective treatments currently available for your cancer?
Are you between 18 and 80 years old?
Has your general health, measured by your ability to do daily activities, been assessed as good enough for the study?
Are any side effects from your previous treatments mostly gone?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the experimental drug PhOx430. The specific amount you receive will depend on which part of the study you are in. You will have regular appointments and tests, including blood and urine samples, to monitor your health and how your body is reacting to the drug. Some patients may also have tissue samples (biopsies) taken before and during the study to help researchers understand the drug better. You will also have scans to check if your tumour is responding to the treatment. The total duration of your participation will depend on how you respond to the treatment and the study's protocol, but you will be closely monitored throughout.

Potential risks and benefits

As with any clinical trial, there are potential benefits and risks. The potential benefit is that PhOx430 might help control your cancer where other treatments have not been successful. However, because this is an early-stage study, the benefits are not guaranteed. There is also a risk of experiencing side effects from the drug, some of which could be serious. The research team will monitor you closely and explain any potential effects before you decide to participate. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (4)

Institut du Cancer de Montpellier
Verified postcode
Montpellier, France· Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Verified postcode
Milan, Italy· Recruiting
IRCCS Ospedale San Raffaele
Verified postcode
Milan, Italy· Recruiting
Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia
Verified postcode
Reggio Emilia, Italy· Recruiting

Common questions

What kind of drug is PhOx430?

PhOx430 is an investigational drug that targets a specific pathway in cancer cells, aiming to stop their growth. It's a new type of treatment being tested.

Why are they studying different cancer types?

The study first looks at various advanced solid tumours to find a safe dose. Then, it focuses on specific aggressive cancers like glioblastoma and triple-negative breast cancer to see how the drug works in those particular conditions.

What does 'dose escalation' mean?

Dose escalation is the first part of the study where different groups of patients receive increasing doses of the drug. This helps researchers find the highest dose that is safe and tolerable.

Will this drug cure my cancer?

This is an early-stage study, so it's mainly focused on safety and finding the right dose. While there's a hope for benefit, it's not known if PhOx430 will cure cancer. Researchers are looking for signs it can control the disease.

Can I stop participating if I want to?

Yes, you have the right to withdraw from the study at any time, for any reason, without affecting your medical care.

How to find out more

Karine Chorro, Mrs.

phast@phostin.com +33 (0) 4 11 93 77 51 Official trial record

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