RecruitingPhase 1NCT07658196

TLR9 Immunotherapy for Peritoneal Carcinomatosis

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


Sponsor

Brown University

Enrollment

24 participants

Start Date

Aug 25, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ACM-CpG for people with appendiceal adenocarcinoma, colorectal adenocarcinoma, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGACM-CpG

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


Locations(1)

Rhode Island and the Miriam Hospitals (Brown University Health)

Providence, Rhode Island, United States

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NCT07658196


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