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Bacterial wall chemical injected into tumors shows promise in early safety trial

NCT ID NCT05751837

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This early study tested whether a sterile bacterial chemical called lipopolysaccharide (LPS) can be safely injected into abdominal tumors during laparoscopic surgery. Twelve adults with advanced digestive tract tumors received one injection into a tumor, and researchers checked for side effects and immune changes. The goal was to see if the treatment is safe and can activate the immune system against the cancer.

What this could mean

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

Active substance
Lipopolysaccharide (LPS), a bacterial wall chemical
What this could lead to
If safe, this could point toward a new way to stimulate the immune system to fight abdominal tumors during surgery.
What could go wrong
This is a very early Phase 1 trial with only 12 people, focused on safety, not effectiveness. The treatment may not shrink tumors or improve outcomes.

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

12 people

The number who actually took part.

Started

Mar 2023

Finished

May 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 99 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: 1. Males or females age 18 to 99 years 2. Pre-menopausal women less than or equal to18 years of age must have a negative urine/serum pregnancy test prior to standard-of-care surgery and investigational treatment. 3. Participants must have an advanced intra-abdominal tumor, including metastatic or recurrent, biopsy-proven, digestive tract tumors. 4. Participants must have at least two index non-visceral intra-abdominal tumors that are grossly visible, \>1cm3 in volume, and amenable to biopsy and injection of investigational drug or control solution at the time of laparoscopy. 5. Participants must be planning or scheduled to undergo a standard-of-care abdominal laparoscopic surgical procedure at AGH or WPH and be potentially eligible for a second, definitive operation to remove the tumor(s) pending the findings during laparoscopy. 6. Must be able to read and understand English and consent for themselves Exclusion Criteria: 1. Pregnant or lactating females 2. Investigational drug use within 30 days prior to enrollment. 3. Immunosuppressive medication including corticosteroids within 30 days prior to enrollment. 4. Active chemotherapy or radiotherapy within 4 weeks of investigational agent injection. 5. Active infection requiring systemic therapy or causing fever \>38.1 degree C or unexplained fever \>38.1 degree C within seven days prior to investigational agent injection 6. Laboratory abnormalities, drawn according to standard clinical care in anticipation of upcoming surgery outside the following limits: AST/SGOT \> 1.5 times the upper limit of normal ALT/SGPT \> 1.5 times the upper limit of normal Total bilirubin \> 1.5 times the upper limit of normal Creatinine \> 1.5 times the upper limit of normal Hemoglobin \< 9 gm/dL White blood cell count \< 3,000/ mm3 Platelet count \< 70,000/mm3 INR \>1.5 times the upper limit of normal PTT \>1.5 times the upper limit of normal 7. History of allergic reaction to the investigational agent carrier solution. 8. Medical contra-indication or allergic reaction to acetaminophen or NSAIDs. 9. Participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures. 10. Adverse events from prior therapy that have not resolved to CTCAE version 5 grade \< and equal to1 prior to enrollment

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Allegheny Health Network Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • Allegheny Health Network West Penn Hospital

    Pittsburgh, Pennsylvania, 15224, United States

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