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Malignant AscitesPhase 1TIPCNCT07658196

TLR9 Immunotherapy for Peritoneal Carcinomatosis

A Phase 1 study testing ACM-CpG in people with Malignant Ascites and Colorectal Adenocarcinoma, run by Brown University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this clinical trial is to determine the safety and efficacy of of ACM-CpG for inoperable peritoneal metastases or malignant ascites. The main questions it aims to answer are: To determine the safety and maximum tolerated dose (MTD) or optimal biologic dose (OBD) of intraperitoneal injection(s) of ACM-CpG… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ACM-CpG
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
25 Aug 2026to Jul 2030
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients eligible for inclusion in this study must meet all of the following criteria:
  • Male or female patients age ≥ 18 years of age at the time of informed consent
  • 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
  • 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
  • Must have evaluable disease by physical examination, serum tumor markers, radiologic assessment, or laparoscopic visual assessment
  • Must have a life expectancy of ≥ 12 weeks as estimated by the investigator
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  • Must have an ECOG status of ≤ 2
  • 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)
  • 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
  • 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

Who cannot join

  • Has received prior TLR9 therapy
  • Has received chemotherapy, radiotherapy, or biological cancer therapy within 21 days or 5 half-lives (whichever is shorter) of the start of treatment
  • Has received an investigational agent within 28 days of the start of treatment
  • Has received a commercial vaccine (flu, COVID, etc.) within 2 weeks of C1D1
  • Has any unresolved toxicity ≥ Grade 2 from previous anti-cancer therapy, except for stable chronic toxicities (≤ Grade 3) that are not expected to resolve
  • Has a history of histologically confirmed metastases outside of the peritoneal cavity, liver, or lungs
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  • 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
  • Tumor causing biliary obstruction not amenable to stenting or percutaneous drainage
  • Ongoing or untreated intra-abdominal infection or bowel obstruction
  • Has known, clinically active Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV) (Note: Testing is not required)
  • Receiving continuous systemic corticosteroid therapy (≥ 10 mg/day of prednisolone or equivalent)
  • 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
  • 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
  • Other active malignancy within 2 years excluding cutaneous squamous or basal cell carcinomas
  • 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
  • History of hypersensitivity to TLR9 agonists
  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Roxanne Wood contact

401-863-3000

roxanne_wood@brown.edu

Eligibility Screening contact

401-444-3234.

United States1 site, 1 recruiting

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

    Providence, Rhode Island, 02903/02906

    BrUOG, 401-863-3000, BrUOG@brown.edu

    Recruiting

Other trials in United States

About this study

Official title: TLR9 Immunotherapy for Peritoneal Carcinomatosis (TIPC) - Phase 1 Study of the Safety and Efficacy of ACM-CpG Intraperitoneal Injections for Treatment in Patients With Colorectal or Appendiceal Adenocarcinoma Peritoneal Metastases or Malignant Ascites

The goal of this clinical trial is to determine the safety and efficacy of of ACM-CpG for inoperable peritoneal metastases or malignant ascites. The main questions it aims to answer are:

  • To determine the safety and maximum tolerated dose (MTD) or optimal biologic dose (OBD) of intraperitoneal injection(s) of ACM-CpG for inoperable peritoneal metastases or malignant ascites? Researchers will assign treatment levels using escalating doses of ACM-CpG Therapy.
Read more

Participants will:

  • Will receive at least one dose of ACM-CpG therapy on Day 1 of a 28-day treatment cycle.
  • May receive up to 2 additional injections if they have clinically stable or responsive disease.
  • Must visit the clinic on Days 1, 4, 7, 10, 14, 21, and 28 for checkups and tests.
  • Will have a CT scan or MRI performed every 8 weeks for 3 scans and then continue to receive scans every 12 weeks to monitor their disease.
Read the detailed description

Escalating doses of ACM-CpG Therapy will use a standard 3+3 design.

Being tested
ACM-CpG
Keywords
Metastatic disease must be primarily located in the peritoneal cavity, ACM-CpG, TLR9, Malignant Ascites, Peritoneal Carcinomatosis,, Appendiceal Adenocarcinoma, CRC
Medical subject headings
Neoplasm Metastasis, Neoplasms, Adenocarcinoma, Mucinous, Peritoneal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACM-CpGDrug

    The dose of ACM-CpG therapy to be infused by intraperitoneal injection will be dependent upon the dose level being delivered at the time of patient enrollment.

    Dose Levels C1D1 ACM-CpG Dose

    -1a (step down dose) 0.1 mg

    1. (starting dose) 0.25 mg
    2. 0.5 mg
    3. 1.0 mg
    4. 2.0 mg
    5. 4.0 mg
    6. 8.0 mg
    7. (optional) 10.0 mg
Study groups in NCT07658196
Study groupRoleWhat they receive
ACM-CpGExperimentalNot described
Receives: Drug: ACM-CpG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

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

    Measured: From enrollment to 30 days post the last dose of ACM-CpG

Secondary outcomes (4)

  1. Progression Free Survival (PFS)

    Measured: From enrollment to disease progression up to 6 months post end of treatment

  2. Disease control rate (DCR)

    The percentage of patients who have achieved complete response, partial response and stable disease

    Measured: From enrollment to End of follow-up (up to 6 months post end of treatment)

  3. Overall Survival (OS)

    Measured: From enrollment to End of follow-up (up to 6 months post end of treatment)

  4. Quality of life composite index

    Measured: From enrollment to 30 days post the last dose of ACM-CpG

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2026
  2. Study start25 Aug 2026
  3. Primary completionJul 2028 (estimated)
  4. Study completionJul 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
3+3 dose escalation
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07658196
Sponsor's protocol ID
BrUOG 452 (ACM-002)
Acronym
TIPC
Status last verified
Sep 2026
First submitted
6 May 2026
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ACM-CpG in people with Malignant Ascites and Colorectal Adenocarcinoma, run by Brown University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Roxanne Wood (401-863-3000, roxanne_wood@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: From enrollment to 30 days post the last dose of ACM-CpG). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07658196.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026; AzTrials last refreshed its copy on 1 Nov 2026.

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