TLR9 Immunotherapy for Peritoneal Carcinomatosis

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Brown University
Study ID
NCT07658196
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ACM-CpG — DRUG
    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

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2030

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: ACM-CpG

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: From enrollment to 30 days post the last dose of ACM-CpG ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rhode Island and the Miriam Hospitals (Brown University Health)ProvidenceRhode Island02903/02906
BrUOG
[email protected]
401-863-3000

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By research site
Rhode Island and the Miriam Hospitals (Brown University Health)· Providence, RI

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