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NOT YET RECRUITING
NCT07658196
PHASE1

TLR9 Immunotherapy for Peritoneal Carcinomatosis

Sponsor: Brown University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2026-08

Completion Date

2030-07

Last Updated

2026-08-20

Healthy Volunteers

No

Interventions

DRUG

ACM-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