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Experimental shot takes aim at stomach cancer spread

NCT ID NCT07658196

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 5 times

Summary

This early-stage trial tests a drug called ACM-CpG, which is injected directly into the abdomen to stimulate the immune system against cancer. It includes 24 adults with colorectal or appendix cancer that has spread to the lining of the abdomen or caused fluid buildup. The main goal is to find a safe dose and see if it helps control the disease.

What this could mean

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

Active substance
ACM-CpG (a drug that stimulates the immune system)
What this could lead to
If it works, this could point toward a new treatment option for cancers that have spread to the abdomen.
What could go wrong
This is a very early phase 1 trial with only 24 people, so it is mainly checking safety and dosing. The drug may not shrink tumors or improve survival.

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 24 people

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

Started

Aug 2026

Expected to finish

Jul 2030

An estimate. End dates often move.

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 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: * Patients eligible for inclusion in this study must meet all of the following criteria: 1. Male or female patients age ≥ 18 years of age at the time of informed consent 2. Must be able to provide written informed consent, stating an understanding of the procedures and investigational nature of the study treatment, and willingness to comply with study requirements 3. Must have documented CRC or appendiceal adenocarcinoma peritoneal carcinomatosis or malignant ascites. Primary tumor may be intact and limited liver and/or lung disease is permitted 4. Must have evaluable disease by physical examination, serum tumor markers, radiologic assessment, or laparoscopic visual assessment 5. Must have a life expectancy of ≥ 12 weeks as estimated by the investigator 6. Must have an ECOG status of ≤ 2 7. Patients with acceptable laboratory values defined as: * Estimated creatinine clearance (calculated using Cockcroft-Gault formula, or measured) ≥ 60 mL/min, not dialysis dependent * Total bilirubin ≤ 1.5 mg/dl, unless elevated bilirubin is clearly related to Gilbert syndrome (and total bilirubin \< 6.0 mg/dl) * Alanine aminotransferase (ALT) ≤ 3.5 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) ≤ 3.5 x ULN * Absolute neutrophil count \> 1.0 x 109/L (must be independent of blood product administration) * Platelet count \> 100 x 109/L (must be independent of blood product administration) * Hemoglobin ≥ 8 g/dL (must be independent of blood product administration) 8. Surgically sterile patients or patients of childbearing potential (CBP) who agree to use highly effective methods of contraception during study dosing and for 6 months after last dose of study drug 9. All other relevant medical conditions must be well-managed and stable, in the opinion of the investigator, for at least 28 days prior to administration of study drug Exclusion Criteria: 1. Has received prior TLR9 therapy 2. Has received chemotherapy, radiotherapy, or biological cancer therapy within 21 days or 5 half-lives (whichever is shorter) of the start of treatment 3. Has received an investigational agent within 28 days of the start of treatment 4. Has received a commercial vaccine (flu, COVID, etc.) within 2 weeks of C1D1 5. Has any unresolved toxicity ≥ Grade 2 from previous anti-cancer therapy, except for stable chronic toxicities (≤ Grade 3) that are not expected to resolve 6. Has a history of histologically confirmed metastases outside of the peritoneal cavity, liver, or lungs 7. Has high volume liver or lung metastases, defined as \> 50% replacement of the liver volume by metastatic disease or \> 5 lung lesions greater than 1 cm in size 8. Tumor causing biliary obstruction not amenable to stenting or percutaneous drainage 9. Ongoing or untreated intra-abdominal infection or bowel obstruction 10. Has known, clinically active Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV) (Note: Testing is not required) 11. Receiving continuous systemic corticosteroid therapy (≥ 10 mg/day of prednisolone or equivalent) 12. Clinically significant cardiac disease or impaired cardiac function, including any of the following: * A history of newly diagnosed transmural myocardial infarction, cerebral infarction, or pulmonary embolism within 6 months, except those approved by the medical monitor * A history of newly diagnosed deep vein thrombosis (DVT) within 3 months * Left ventricular ejection fraction (LVEF) \< 50% * QTc \>480 msec 13. Active bacterial, viral, or fungal infection: patients with ongoing use of prophylactic antibiotics, antiviral agents, or antifungal agents remain eligible as long as there is no evidence of active infection 14. Other active malignancy within 2 years excluding cutaneous squamous or basal cell carcinomas 15. Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results 16. History of hypersensitivity to TLR9 agonists 17. Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation)

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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.

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

  • Rhode Island and the Miriam Hospitals (Brown University Health)

    RECRUITING

    Providence, Rhode Island, 02903/02906, United States

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