TLR9 Immunotherapy for Peritoneal Carcinomatosis
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Brown University
You may qualify if…
- ✓ 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:
You may not qualify if…
- ✕ 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
Where it's recruiting
Providence
Source: ClinicalTrials.gov · NCT07658196 · last updated 2026-08-27