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TLR9 Immunotherapy for Peritoneal Carcinomatosis

NCT07658196 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-08-27

No results posted yet for this study

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.

Conditions

  • Malignant Ascites
  • Colorectal Adenocarcinoma
  • Peritoneal (Metastatic) Cancer
  • Appendiceal Adenocarcinoma

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

Sponsors & Collaborators

  • Brown University

    lead OTHER

Principal Investigators

  • Khaldoun Almhanna, MD · Brown University Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-25
Primary Completion
2028-07-31
Completion
2030-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07658196 on ClinicalTrials.gov