TLR9 Immunotherapy for Peritoneal Carcinomatosis (NCT07658196) | Clinical Trial Compass
Not Yet RecruitingPhase 1
TLR9 Immunotherapy for Peritoneal Carcinomatosis
United States24 participantsStarted 2026-07
Plain-language 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 for inoperable peritoneal metastases or malignant ascites? Researchers will assign treatment levels using escalating doses of ACM-CpG Therapy.
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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
. Must have an ECOG status of ≤ 2
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Timeframe: From enrollment to 30 days post the last dose of ACM-CpG
. Patients with acceptable laboratory values defined as:
. 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
Exclusion criteria
. 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
. 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