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TLR9 Immunotherapy for Peritoneal Carcinomatosis

{ "TLR9 Immunotherapy for Peritoneal Carcinomatosis", "This study is testing a treatment called ACM-CpG for people with inoperable peritoneal metastases (cancer that has spread to the lining of the abdomen) or malignant ascites (fluid buildup in the abdomen caused by cancer). The main goals are to find out how safe ACM-CpG is, what the highest safe dose is, and if it helps treat the cancer. Participants will receive ACM-CpG as an injection into the abdomen. You can join if you are 18 years or older and meet other study criteria. The study is currently unclear about its recruitment status and plans to enroll 24 participants.", "design": "This is an interventional study that will enroll 24 participants. Researchers will give increasing doses of ACM-CpG to different groups of participants to find the safest and most effective amount.", "commitments": "You will receive at least one injection of ACM-CpG and may receive up to two more if your disease is stable or improving. You will need to visit the clinic frequently on specific days (1, 4, 7, 10, 14, 21, and 28) for checkups and tests.", "compensation": "Not stated in the trial record.", "follow_up": "Your safety will be monitored from enrollment until 30 days after your last dose of ACM-CpG.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07658196

TLR9 Immunotherapy for Peritoneal Carcinomatosis

Recruiting
PHASE1Ages 18+InterventionalTreatment
Brown University
~24 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:ACM-CpG

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Measured over From enrollment to 30 days post the last dose of ACM-CpG

Conditions

Malignant Ascites
Colorectal Adenocarcinoma
Peritoneal (Metastatic) Cancer
Appendiceal Adenocarcinoma

Explore related trials

Appendix CarcinomaColorectal CarcinomaMalignant Peritoneal Effusion

Where it's being run

1 sites across 1 states
Rhode Island1

Study leadership

  • Khaldoun Almhanna, MD · PRINCIPAL_INVESTIGATOR · Brown University Health

Who to contact

Roxanne Wood
[email protected]
401-863-3000
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]From enrollment to 30 days post the last dose of ACM-CpG

    includes dose limiting toxicities (DLTs), Serious adverse events (SAEs), hospitalizations, CRS, neurotoxicity, and clinically significant laboratory abnormalities