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New 'Smart Bomb' radiation therapy targets multiple cancers in early trial

NCT ID NCT06562192

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jul 30, 2026 · Updated 5 times

Summary

This early-stage trial is testing a new type of targeted radiation therapy for people with advanced pancreatic, lung, breast, or colorectal cancers. The treatment uses a radioactive drug that seeks out cancer cells to deliver radiation directly, aiming to kill them while sparing healthy tissue. The study will enroll 162 adults to check safety, find the right dose, and get a first look at whether it shrinks tumors.

What this could mean

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

Active substance
radioligand therapy ([177Lu]Lu-NNS309) and imaging agent ([68Ga]Ga-NNS309)
What this could lead to
If successful, this could lead to a new targeted radiation treatment for several hard-to-treat cancers, potentially shrinking tumors with fewer side effects than traditional chemotherapy.
What could go wrong
This is a very early Phase 1 trial, so the main goal is safety, not effectiveness. The therapy may not work, could cause serious side effects, and is only tested in a small number of people.

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 162 people

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

Started

Oct 2024

Expected to finish

Jan 2031

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 to 100 years

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.

Inclusion Criteria: * Age ≥ 18 years old * Patients with one of the following indications: * Locally advanced unresectable or metastatic PDAC with disease progression following, or intolerance to cytotoxic chemotherapy, unless patient was ineligible to receive such therapy * Locally advanced unresectable or metastatic NSCLC without any actionable genomic alterations with disease progression following, or intolerance to chemotherapy and immunotherapy, unless patient was ineligible to receive such therapy, or locally advanced unresectable or metastatic NSCLC with an actionable genomic alteration with disease progression following, or intolerance to targeted therapy, unless patient was ineligible to receive such therapy * Locally advanced unresectable or metastatic HR+/HER2- ductal or lobular BC with disease progression following, or intolerance to, at least 2 lines of therapy, unless patient was ineligible to receive such therapy * Locally advanced unresectable or metastatic TNBC with disease progression following, or intolerance to, at least 2 lines of therapy, unless patient was ineligible to receive such therapy * Locally advanced or metastatic unresectable CRC with disease progression following, or intolerance to cytotoxic chemotherapy, unless patient was ineligible to receive such therapy. Patients with known microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status must also have had disease progression following, or intolerance to immune checkpoint inhibitor therapy, unless patient was ineligible to receive such therapy * Patients must have lesions showing 68Ga-NNS309 uptake Exclusion Criteria: * Absolute neutrophil count (ANC) \< 1.5 x 10\^9/L, hemoglobin \< 9 g/dL, or platelet count \< 100 x 10\^9/L * QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec * Calculated estimated glomerular filtration rate \< 60 mL/min/1.73m2 * Unmanageable urinary tract obstruction or urinary incontinence * Radiation therapy within 4 weeks prior to the first dose of \[177Lu\]Lu-NNS309 Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

breast neoplasm colorectal cancer colorectal neoplasm hormone receptor-positive breast cancer non-small cell lung carcinoma pancreatic ductal adenocarcinoma triple-negative breast carcinoma

As listed by the trial registrant

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

Colorectal cancer HR+/HER2- ductal and lobular breast cancer Non-small cell lung cancer Pancreatic ductal adenocarcinoma 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

    29 sites in 10 countries. 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

  • BAMF Health

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic Jacksonville

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Novartis Investigative Site

    RECRUITING

    Brussels, 1000, Belgium

  • Novartis Investigative Site

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Novartis Investigative Site

    RECRUITING

    Montreal, Quebec, H2X 1R9, Canada

  • Novartis Investigative Site

    RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • Novartis Investigative Site

    RECRUITING

    Bron, 69677, France

  • Novartis Investigative Site

    RECRUITING

    Villejuif, 94800, France

  • Novartis Investigative Site

    RECRUITING

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Novartis Investigative Site

    RECRUITING

    Essen, 45147, Germany

  • Novartis Investigative Site

    RECRUITING

    München, 80377, Germany

  • Novartis Investigative Site

    RECRUITING

    Rostock, 18057, Germany

  • Novartis Investigative Site

    RECRUITING

    Tel Aviv, 6423906, Israel

  • Novartis Investigative Site

    RECRUITING

    Milan, MI, 20133, Italy

  • Novartis Investigative Site

    RECRUITING

    Reggio Emilia, RE, 42123, Italy

  • Novartis Investigative Site

    RECRUITING

    Nijmegen, Gelderland, 6500HB, Netherlands

  • Novartis Investigative Site

    RECRUITING

    Utrecht, 3584 CX, Netherlands

  • Novartis Investigative Site

    RECRUITING

    Barcelona, 08036, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28009, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28040, Spain

  • Novartis Investigative Site

    RECRUITING

    Geneva, 1211, Switzerland

  • Novartis Investigative Site

    RECRUITING

    Lausanne, 1011, Switzerland

  • Stanford University Medical Center

    RECRUITING

    Palo Alto, California, 94304, United States

  • Uni Of TX MD Anderson Cancer Cntr

    RECRUITING

    Houston, Texas, 77030, United States

  • Uni of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35249, United States

  • University Of Washington

    RECRUITING

    Seattle, Washington, 98109, United States

  • University of California LA

    RECRUITING

    Los Angeles, California, 90095, United States

More trials for these conditions

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