AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

A phase I study of [177Lu]Lu-DWJ155 and [68Ga]Ga-DWJ155 in patients with solid tumors

This Phase I clinical trial is looking at two new experimental drugs called [68Ga]Ga-DWJ155 and [177Lu]Lu-DWJ155. They are designed to work together as a pair. The first drug is used during a special scan to locate cancer cells in the body. The second drug delivers a small dose of radiation directly to those cancer cells to help destroy them, while trying to spare healthy tissues. Because this is a Phase I study, it is one of the first times these drugs are being tested in humans. The main goal is to find out if the treatment is safe, discover any side effects, and determine the best dose to give. The trial is open to adults with certain advanced cancers, including advanced bladder, breast, non-small cell lung, or stomach cancer, whose current treatments may no longer be working.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Novartis Pharma AG

Enrolment target

Start

29 Sep 2026

Advanced bladder cancer, Advanced Breast cancer (HER2+, HR+/HER2-negative or TNBC), Advanced Non-small cell lung cancer (NSCLC), Advanced gastric/Gastroesophageal junction adenocarcinoma (GEJ) cancer

What is this study about?

This clinical trial is testing a new type of treatment called targeted radionuclide therapy. Many standard cancer treatments, like chemotherapy, affect healthy cells as well as cancer cells. This study explores a 'search and destroy' approach that aims to be much more precise. It uses two closely related drugs: one acts like a spotlight to show doctors where the cancer is, and the other acts like a guided missile to deliver radiation directly to those spots.

The first medicine, [68Ga]Ga-DWJ155, is a radioactive tracer. When injected, it travels through the blood and latches onto specific markers on cancer cells. A special scanner (a PET scan) can then take pictures of where the drug has landed. If the scan shows that the drug sticks well to the tumour, doctors give the second drug, [177Lu]Lu-DWJ155. This second medicine carries a stronger form of radiation designed to damage and shrink the tumour cells from the inside.

This trial is important because it offers hope for people whose advanced cancer has stopped responding to standard treatments. It is open to patients with advanced bladder cancer, specific types of breast cancer, non-small cell lung cancer, and stomach cancer. Because this is a Phase I study—one of the earliest stages of human research—doctors are mainly focused on making sure the treatment is safe, identifying any side effects, and finding the right dose for future testing.

Key takeaways

Tests a new 'search and destroy' radiation therapy for advanced solid cancers.
Combines a special imaging scan with a targeted radiation drip.
A Phase I study focused on finding the safest and most effective dose.
Open to adults with advanced lung, breast, bladder, or stomach cancers.
Completely voluntary, with close medical supervision throughout.

Who may be eligible?

This study is designed for adults aged 18 and over who have been diagnosed with an advanced solid tumour. 'Advanced' usually means the cancer has spread to other parts of the body or cannot be completely removed with surgery.

Specifically, the trial is open to people with advanced bladder cancer, non-small cell lung cancer, stomach (gastric) cancer, or certain types of breast cancer (including HER2-positive, HR-positive, or triple-negative breast cancer). Usually, people joining this trial will have already tried standard treatments that have stopped working.

To take part, you will need to be well enough to carry out daily activities and attend regular hospital appointments. You may not be eligible if you have severe heart, liver, or kidney problems, or if you are pregnant or breastfeeding. Your hospital medical team will run blood tests and health checks to confirm if joining the trial 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 aged 18 or older.
I have advanced bladder, breast, lung, or stomach cancer.
My cancer has spread or is no longer responding to standard treatments.
I am well enough to look after myself and travel to hospital appointments.
I am willing to have scans, blood tests, and receive intravenous treatments.

Answer every question to see your result.

What does participation involve?

Taking part in this trial involves several hospital visits. First, you will have a screening visit where the team checks your medical history, takes blood samples, and performs physical checks to make sure you qualify. You will then receive the imaging drug through a drip in your vein and have a PET scan to see if the drug attaches to your tumour cells.

If the scan shows a good match, you will receive the treatment drug, also given via a drip into a vein. Because this medicine contains a small amount of radiation, you may need to stay in the hospital for a short period while the radiation levels settle. You will have regular follow-up visits with blood tests, scans, and physical checks so doctors can monitor your health and watch for side effects. Overall, participation can last several months, followed by longer-term check-ups to track your progress.

Potential risks and benefits

Because this is an early-stage trial, you might not directly benefit from the treatment, although it is hoped that the drug may help slow or shrink your cancer. Your participation will also help doctors learn how to treat cancer better in the future. The risks include unexpected side effects from a new drug, as well as known side effects of radiation such as tiredness, nausea, or changes in blood cell counts. Your medical team will monitor you very closely and treat any problems quickly. Joining the trial is entirely your choice, and you can withdraw at any time without it affecting your normal medical care.

Locations (6)

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
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Unverified
Portugal
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Unverified
Germany
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Unverified
Belgium

Common questions

What is a Phase I clinical trial?

A Phase I trial is the earliest phase of testing in humans. Its main purpose is to test safety, find out what side effects happen, and discover the best dose to use.

Will I be radioactive after receiving the treatment?

The treatment uses a small amount of radiation. For a short time after each dose, you may carry a mild amount of radiation, but the hospital team will give you simple safety guidelines to protect family and friends.

Do I have to pay to take part in the trial?

No, you do not have to pay for the trial medicine or tests. In many cases, trials can also help cover your travel and parking costs.

Can I leave the study if I change my mind?

Yes, taking part is completely voluntary. You can stop participating at any time, for any reason, and your regular NHS or medical care will continue as normal.

How is the study medicine given?

Both the scanning drug and the treatment drug are given as a liquid through a drip (infusion) into a vein in your arm.