24 Participants NeededMy employer runs this trial

ACM-CpG for Peritoneal Cancer

(TIPC Trial)

RW
Overseen ByRoxanne Wood
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called ACM-CpG, an experimental therapy for individuals with inoperable peritoneal metastases or malignant ascites, serious cancer conditions affecting the abdomen. The main goal is to assess the treatment's safety and determine the optimal dose. Participants will receive at least one injection of ACM-CpG and undergo regular checkups to monitor their health. This trial may suit those with documented peritoneal carcinomatosis or malignant ascites who can attend frequent clinic visits. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you have received chemotherapy, radiotherapy, or biological cancer therapy within 21 days of starting the trial, or if you are on continuous systemic corticosteroid therapy.

Is there any evidence suggesting that ACM-CpG is likely to be safe for humans?

Previous studies have shown that ACM-CpG is well tolerated. Research indicates that it activates the body's immune response without causing serious side effects. Importantly, no dose-limiting toxicities (side effects severe enough to stop treatment) have been observed. This finding is encouraging for those considering joining a clinical trial, as it suggests the treatment is generally safe for human use.12345

Why do researchers think this study treatment might be promising for peritoneal cancer?

ACM-CpG is unique because it represents a novel approach to treating peritoneal cancer by activating the immune system. Unlike traditional treatments such as surgery, chemotherapy, or targeted drugs that directly attack cancer cells, ACM-CpG works by stimulating the immune system to recognize and fight the cancer. This immune activation is achieved through a specific component called CpG, which is designed to enhance the body's natural defenses against tumors. Researchers are excited about ACM-CpG because it offers the potential for a more personalized and less invasive treatment option, potentially leading to better outcomes with fewer side effects.

What evidence suggests that ACM-CpG might be an effective treatment for peritoneal cancer?

Research shows that ACM-CpG, the treatment being tested in this trial, is designed to help the body's immune system fight cancer. Early studies indicate that patients tolerated the treatment well, experiencing no severe side effects. The treatment has also shown signs of activating the immune system, which could help combat cancer that has spread in the abdominal lining or cancer-related fluid buildup in the abdomen. While concrete data on its effectiveness is still being gathered, the encouraging immune response suggests potential benefits for patients with these challenging conditions.12456

Who Is on the Research Team?

KA

Khaldoun Almhanna, MD

Principal Investigator

Brown University Health

Are You a Good Fit for This Trial?

This trial is for adults with inoperable peritoneal metastases or malignant ascites from cancers like colorectal, rectal, biliary tract, appendiceal adenocarcinoma, or peritoneal cancer. Participants must be able to attend regular clinic visits and imaging scans.

Inclusion Criteria

Must have a life expectancy of ≥ 12 weeks as estimated by the investigator
Patients with acceptable laboratory values: estimated creatinine clearance ≥ 60 mL/min, total bilirubin ≤ 1.5 mg/dl (unless related to Gilbert syndrome and < 6.0 mg/dl), ALT ≤ 3.5 x ULN, AST ≤ 3.5 x ULN, absolute neutrophil count > 1.0 x 10^9/L, platelet count > 100 x 10^9/L, hemoglobin ≥ 8 g/dL, all independent of blood product administration
Must be able to provide written informed consent and willingness to comply with study requirements
See 6 more

Exclusion Criteria

I do not have an active abdominal infection or bowel blockage.
Any medical condition preventing participation due to safety, compliance, or interpretation concerns
History of hypersensitivity to TLR9 agonists
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ACM-CpG therapy with at least one dose on Day 1 of a 28-day treatment cycle, with potential for up to 2 additional injections based on disease stability or response.

28 days per cycle
Visits on Days 1, 4, 7, 10, 14, 21, and 28

Follow-up

Participants are monitored for safety and effectiveness after treatment, with CT or MRI scans every 8 weeks for 3 scans, then every 12 weeks.

Up to 6 months post end of treatment

What Are the Treatments Tested in This Trial?

Interventions

  • ACM-CpG

Trial Overview

The study tests ACM-CpG immunotherapy given directly into the abdomen to find a safe dose and see if it helps control cancer that has spread within the belly. Patients get at least one injection per cycle and may receive more if their disease is stable or improving.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: ACM-CpGExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brown University

Lead Sponsor

Trials
480
Recruited
724,000+

Citations

TLR9 Immunotherapy for Peritoneal Carcinomatosis

The goal of this clinical trial is to determine the safety and efficacy of of ACM-CpG for inoperable peritoneal metastases or malignant ascites.

Brown University Health, Arcamyra Therapeutics to Launch ...

The trial builds on early clinical evaluation of ACM-CpG the investigational therapy has been well tolerated and has shown evidence of innate ...

Brown University Health and Arcamyra to launch Phase I ...

The Phase I study is expected to generate data on safety, tolerability and early biological activity to support future development of ACM-CpG

Intramuscular ACM-CpG Monotherapy in Patients With ...

This Phase I trial will assess the safety and early signs of efficacy of intramuscular injection of ACM-CpG in patients with advanced malignant solid tumors.

Immunotherapy for Peritoneal Carcinomatosis - PMC - NIH

They found that pembrolizumab showed promising results in patients with dMMR/MSI-H solid tumors, with an overall response rate of 34.3% and a median duration of ...

TLR9 Immunotherapy for Peritoneal Carcinomatosis (TIPC)

The goal of this clinical trial is to determine the safety and efficacy of of ACM-CpG for inoperable peritoneal metastases or malignant ascites.