AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

A PHASE I, OPEN-LABEL, MULTICENTER, DOSE ESCALATION AND COHORT EXPANSION STUDY OF MINT91 IN COMBINATION WITH OTHER ANTI-CANCER DRUGS IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS

This study is an early research trial (Phase I) testing an experimental drug called MINT91 for the first time in people. Doctors want to see how safe the drug is when given together with other cancer treatments. They also want to find the best and safest dose to use. The trial is open to adult women who have advanced solid tumours. This means cancers that form a solid lump, rather than blood cancers, which have spread either to nearby tissues or to other parts of the body. Because this is a dose-finding study, small groups of participants will try different amounts of the drug while doctors watch closely for any side effects. Taking part involves regular hospital visits, health checks, and tests to monitor how the body and tumour respond to the treatment.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Chugai Pharmaceutical Co. Ltd.

Enrolment target

Start

30 Sep 2026

LOCALLY ADVANCED OR METASTATIC SOLID TUMORS

What is this study about?

When cancer treatments stop working or when cancer has spread, doctors look for new ways to treat it. This clinical trial is studying a new, experimental drug called MINT91. It is being tested in combination with other existing anti-cancer medicines. The main goal of this early-stage study is to find out how safe MINT91 is, what side effects it might cause, and how much of it can be given safely to patients.

Because this is a 'Phase I' trial, it is one of the first times this drug is being given to humans. Researchers begin by giving very low doses to a small group of people. If that dose is safe, the next group receives a slightly higher dose. Once the best dose is found, more people may be invited to join to see how well the combination helps shrink or slow down tumour growth.

This study matters because it helps scientists learn whether MINT91 could become a useful new option for treating advanced cancers in the future. While early research cannot promise individual benefit, the information gathered helps improve care and guides future cancer therapies.

Key takeaways

Tests a new medicine called MINT91 alongside other cancer drugs.
Open to women aged 18 and older with advanced solid tumours.
First-in-human trial focused on safety and finding the best dose.
Requires regular clinic visits for scans, blood tests, and close monitoring.
Taking part is voluntary, and you can stop at any time.

Who may be eligible?

This trial is specifically for women who are 18 years of age or older and have been diagnosed with an advanced solid tumour. A solid tumour is an abnormal mass of cells forming a lump in an organ or tissue, such as in the breast, bowel, or lung, rather than a blood cancer like leukaemia.

To be eligible, the cancer must be 'locally advanced' (grown deeply into nearby areas) or 'metastatic' (spread to other parts of the body). Usually, this means standard treatments have already been tried or are no longer controlling the cancer.

The medical team will check other health details, such as how well your liver, kidneys, and heart are working, to make sure it is safe for you to take part. Your doctor or the study team can review your medical history to see if this trial is suitable for you.

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.

I am a woman aged 18 or older.
I have been diagnosed with a solid tumour (not a blood cancer).
My cancer is locally advanced or has spread to other areas (metastatic).
I am well enough to attend regular hospital appointments and tests.
I am open to trying an experimental cancer treatment.

Answer every question to see your result.

What does participation involve?

Taking part in this study means visiting a hospital clinic regularly for treatment and monitoring. You will receive MINT91 along with other cancer medicines, usually given as tablets or through a drip into a vein. During visits, you will have standard health checks, such as blood tests, heart traces (ECGs), and physical exams. You will also have periodic scans (like CT or MRI scans) to see how the cancer is responding. Because this is an early-phase trial, the doctors will monitor you very closely, especially during the first few weeks. The total time you stay on the study depends on how well you tolerate the treatment and whether your cancer stays stable, followed by check-ins to monitor your health.

Potential risks and benefits

Because MINT91 is being tested in humans for the first time, not all of its side effects are known yet. You might experience mild to severe side effects from the study drug or the medicines given with it. The treatment might not shrink your cancer, but it could help slow its growth, and the information gained could help future cancer patients. You will be monitored very closely for any problems, and you have the right to leave the trial at any time without it affecting your standard NHS care.

Locations (1)

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

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Unverified
France

Common questions

What is a Phase I clinical trial?

A Phase I trial is the earliest stage of human testing. It focuses mainly on finding out if a new drug is safe, what side effects it causes, and the best dose to use.

Does taking part cost anything in the UK?

No, the trial treatment and all study-related tests are provided free of charge, and some trials offer support for travel expenses.

Can I leave the study if I change my mind?

Yes, you can leave the study at any point. Deciding to leave will not affect your relationship with your healthcare team or your future care.

Will this drug cure my cancer?

Because this is an early safety study, doctors cannot promise it will cure your cancer. The main aim is to test safety and find the right dose.

How often will I need to go to the hospital?

Visits are usually quite frequent, especially at the start of the study, so doctors can run tests and check carefully for side effects.