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Experimental radioactive therapy targets Hard-to-Treat cancers

NCT ID NCT05977322

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 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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested a radioactive drug called 177Lu-FF58 in 24 people with advanced pancreatic, gastroesophageal, or brain cancer. The drug seeks out and attaches to specific proteins on cancer cells to deliver radiation directly. The main goals were to check safety, find the right dose, and see if the drug could shrink tumors.

What this could mean

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

Active substance
177Lu-FF58 (a radioactive drug that targets specific proteins on cancer cells)
What this could lead to
If successful, this could point toward a new treatment option for advanced solid tumors that have few alternatives.
What could go wrong
This is a very early Phase 1 trial with only 24 participants, so safety and effectiveness are not yet known. The study was terminated, which may indicate challenges.

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

24 people

The number who actually took part.

Started

Oct 2023

Finished

Dec 2024

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.

Key Inclusion criteria * Age \>= 18 years old * Patients with locally advanced unresectable or metastatic PDAC, locally advanced unresectable or metastatic GEA, or recurrent GBM * To be treated with \[177Lu\]Lu-FF58, patients must have at least one measurable lesion that shows \[68Ga\]Ga-FF58 uptake on PET/CT or PET/MRI Key Exclusion criteria * Absolute neutrophil count (ANC) \< 1.5 x 109/L, hemoglobin \< 10 g/dL, or platelet count \< 100 x 109/L * Prior external beam radiation therapy (EBRT) to \> 25% of the bone marrow * Creatinine clearance \< 60 mL/min * Unmanageable bladder outflow obstruction or urinary incontinence * Non-GBM patients: Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy (such as radiotherapy or surgery), or increasing doses of corticosteroids within 1 week before \[177Lu\]Lu-FF58 administration Other protocol-defined inclusion/exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

Adenocarcinoma Of Esophagus Esophageal Neoplasms gastric neoplasm gastroesophageal adenocarcinoma glioblastoma glioma susceptibility 1 pancreatic ductal adenocarcinoma pancreatic neoplasm

As listed by the trial registrant

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

Gastroesophageal adenocarcinoma Glioblastoma multiforme Pancreatic ductal adenocarcinoma

Contacts and locations

Locations

  • Novartis Investigative Site

    Tel Aviv, 6423906, Israel

  • Novartis Investigative Site

    Nijmegen, 6500HB, Netherlands

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Catalonia, 08907, Spain

  • Novartis Investigative Site

    Madrid, 28034, Spain

  • Novartis Investigative Site

    Geneva, CH 1211, Switzerland

More trials for these conditions

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