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New cancer drug injected into tumors shows promise in early trial

NCT ID NCT07395258

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This early study tests a new drug called BI 3923948, given as injections into the tumor, either alone or with a checkpoint inhibitor (ezabenlimab) given by IV. It includes about 60 adults with advanced solid tumors that have spread and are not responding to other treatments. The main goal is to find a safe dose and see if the combination can 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
BI 3923948 (injected into the tumor) and ezabenlimab (a checkpoint inhibitor given by IV)
What this could lead to
If it works, this could point toward a new treatment option for advanced solid tumors that have not responded to other therapies.
What could go wrong
This is a very early Phase 1 trial with only 60 participants, so the drug may not work or could have serious side effects. The trial is currently suspended, which adds uncertainty.

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 60 people

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

Started

Apr 2026

Expected to finish

Feb 2032

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.

Inclusion criteria: 1. Measurable disease as defined per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. 2. Patient has 1 or more accessible lesions (2 or more preferred) 3. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 4. Life expectancy of at least ≥3 months after the start of the treatment according to the investigator's judgement Further inclusion criteria apply. Exclusion criteria: 1. Patients with known primary brain tumors, leptomeningeal disease or untreated brain metastases. Subjects with previously treated brain metastases may participate provided the brain metastases are stable 2. Previous treatment with vesicular stomatitis virus (VSV)-based agents 3. Concomitant medication or condition considered a high risk for complications from injection 4. History of common terminology criteria for adverse events (CTCAE) v5 grade 3 or higher severe hypersensitivity reactions to previous anti-programmed cell death 1 (anti-PD-1)/anti-programmed cell death ligand 1 (PD-L1) monoclonal antibody (mAb) (Arm B only) Further exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

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

Solid tumors

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

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