AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

A PHASE I FIRST-IN-HUMAN, OPEN-LABEL, MULTICENTER STUDYTO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PRELIMINARY ANTITUMOR ACTIVITY OF SIM0505 IN ADULT PARTICIPANTS WITH ADVANCED SOLID TUMORS

This clinical trial is testing a new experimental medicine named SIM0505 for the very first time in humans. It is designed for adult women with advanced solid tumours, which are cancers that have grown or spread and are no longer responding well to standard treatments. Because this is an early-stage Phase 1 study, the main goal is safety. Doctors want to see how the human body handles the drug, how it moves through the bloodstream, and what side effects it might cause. They also want to find the best dose to use in future studies. Participants will receive SIM0505 and have regular check-ups, scans, and blood tests so doctors can monitor their health closely. While there is no guarantee the drug will shrink tumours, the study helps researchers learn whether it could become a useful cancer treatment in the future.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Nextcure Inc.

Enrolment target

Start

09 Sep 2026

Advanced solid tumors

What is this study about?

Solid tumours are lumps of cancer cells that can form in various organs of the body, such as the breasts, lungs, or bowels. When a tumour is described as 'advanced', it means the cancer has grown into nearby tissues or spread to other parts of the body. In many cases, standard treatments like chemotherapy or radiotherapy may have stopped working, meaning new options are urgently needed.

This trial is looking at an experimental drug called SIM0505. It is a 'first-in-human' study, which means people have never taken this medicine before. Laboratory tests have shown promising signs, but scientists now need to find out how the drug behaves in real patients. The study is 'open-label', meaning both you and your study doctors will know you are receiving the trial medicine rather than a dummy treatment.

Taking part helps doctors understand what dose of SIM0505 is safe, how the body breaks it down, and whether it can help control cancer growth. Even though early studies focus mainly on safety rather than a cure, they are a vital step toward discovering new and better cancer therapies for the future.

Key takeaways

Tests a new medicine called SIM0505 in humans for the first time.
Open to adult women with advanced solid tumours who have limited treatment options.
The primary goal is to find a safe dose and learn about possible side effects.
All participants receive the study drug; there is no dummy pill (placebo).
Requires frequent hospital visits for blood tests, health checks, and scans.
You can withdraw from the study at any point without losing your usual care.

Who may be eligible?

This trial is open to adult women aged 18 and over who have been diagnosed with an advanced solid tumour. It is generally meant for people whose cancer has spread or returned, and for whom standard NHS treatments are either no longer working or not suitable.

Because safety is the top priority, participants must be well enough to carry out everyday activities and attend frequent hospital appointments. Your heart, liver, and kidneys will need to be working reasonably well to handle the new medicine.

You may not be able to take part if you have certain other medical conditions, severe active infections, or if you are currently taking medications that could interact dangerously with the trial drug. The trial team will review your full medical history and perform tests to make sure joining is safe 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 an advanced solid tumour.
My cancer has grown, spread, or stopped responding to standard treatments.
I am well enough to attend regular hospital appointments.
I am willing to have routine blood tests and hospital scans.

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will first have a screening visit with tests such as blood work, heart checks, and imaging scans to confirm the study is right for you. Once enrolled, you will receive the study drug SIM0505, which is given under the close care of the hospital team. You will have regular visits where doctors take blood samples to measure drug levels and check your overall health.

You will also have routine scans to see how your tumour is responding to the treatment. Because this is a safety study, visits may be quite frequent, especially during the first few weeks. You will continue on the study as long as the treatment is helping you and side effects are manageable. Even after you finish taking the drug, the team will check on you during follow-up visits to see how you are doing.

Potential risks and benefits

Because SIM0505 is being tested in humans for the first time, there is a risk of unexpected side effects, which could range from mild symptoms like tiredness or nausea to more serious health problems. The treatment might also not help shrink your tumour. However, you will be monitored very closely by specialist doctors, and any side effects will be treated quickly. A potential benefit is that the drug might help control your cancer, and taking part helps advance scientific knowledge for others. You are completely free to leave the trial at any time, and doing so will never affect the quality of your normal medical care.

Locations (4)

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

—
Unverified
Italy
—
Unverified
Poland
—
Unverified
France
—
Unverified
Spain

Common questions

What does a 'Phase 1' trial mean?

A Phase 1 trial is the earliest stage of testing a new drug in humans. Its main goal is to find out if the medicine is safe, what the right dose is, and what side effects it might cause.

Will I receive a placebo (dummy drug)?

No. This is an open-label study, which means every person who joins will receive the actual study medicine, SIM0505.

Will taking part cure my cancer?

It is unlikely to cure your cancer. The main aim of this study is safety, although doctors will also watch closely to see if it helps shrink or stabilise your tumour.

Do I have to pay to take part?

No, you do not pay for clinical trial medicines in the UK. In many cases, travel costs to and from hospital visits may also be covered.

Can I leave the study if I change my mind?

Yes, taking part is completely voluntary. You can choose to stop at any time without giving a reason, and your regular NHS care will continue as normal.