Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can a new tracer make tumors light up on scans?

NCT ID NCT07801508

Diagnosis Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 03, 2026 · Last updated Sep 09, 2026 · Updated 2 times

Summary

This trial tests an experimental imaging agent called [68Ga]Ga-DWJ155 in adults with advanced cancers of the breast, lung, or stomach. The agent is designed to attach to tumor cells and show up on PET scans, helping doctors see where cancer has spread. Researchers will measure how well the agent highlights tumors compared to normal tissue, and they will also check its safety and how the body processes it. The study includes people with specific types of advanced breast cancer, non-small cell lung cancer, and gastroesophageal adenocarcinoma.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A radioactive imaging agent called [68Ga]Ga-DWJ155 (also known as FKL480), given as an injection for PET scans
What this could lead to
If it works, this imaging agent could help doctors see tumors more clearly on PET scans, potentially guiding treatment decisions for several advanced cancers.
What could go wrong
This is an early phase 1 study with a small number of participants, so the imaging agent may not bind well to tumors or may not be safe. It is not yet known if it will improve cancer care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 66 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Age ≥ 18 years old * Presence of at least one extracranial measurable lesion by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Patients with one of the following indications: * HR+/HER2- aBC and TNBC: untreated or currently receiving or having completed first line of systemic therapy (preferred); HER2+ aBC: regardless of any prior systemic therapy * aNSCLC adenocarcinoma: Prior to, during or having completed their first line of systemic therapy. If HER2 immunohistochemistry (IHC) will be routinely performed and available, then HER2 ≥1+ * aGEA: regardless of any prior systemic line of therapy Key Exclusion Criteria: * Out-of-range laboratory values defined as: * Estimated glomerular filtration rate (eGFR; calculated using CKD-EPI 2021 formula, or measured) \< 40 mL/min/1.73m2 * Platelet count \< 75 x 10\^9/L * Hemoglobin \< 9 g/dL * Absolute neutrophil count (ANC) \< 1.0 x 10\^9/L * Patients with inadequate hepatic function * Urinary tract obstruction or urinary incontinence * Pregnant or breastfeeding women Other protocol-defined inclusion/exclusion criteria may apply.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Advanced breast cancer are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

adenocarcinoma breast cancer breast neoplasm gastric neoplasm gastroesophageal adenocarcinoma HER2 positive breast carcinoma hormone receptor-positive breast cancer lung adenocarcinoma non-small cell lung carcinoma triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced breast cancer Advanced gastroesophageal adenocarcinoma Advanced non-small cell lung cancer Triple negative breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Novartis Investigative Site

    RECRUITING

    Kyoto, 6068507, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.