TLR9 Immunotherapy for Peritoneal Carcinomatosis

NCT07658196 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: BrUOG 452 (ACM-002)
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Metastatic disease must be primarily located in the peritoneal cavity; ACM-CpG; TLR9; Malignant Ascites; Peritoneal Carcinomatosis,; Appendiceal Adenocarcinoma; CRC

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  includes dose limiting toxicities (DLTs), Serious adverse events (SAEs), hospitalizations, CRS, neurotoxicity, and clinically significant laboratory abnormalities

  From enrollment to 30 days post the last dose of ACM-CpG

Secondary Outcomes (4)

• Progression Free Survival (PFS)

  From enrollment to disease progression up to 6 months post end of treatment

• Disease control rate (DCR)

  From enrollment to End of follow-up (up to 6 months post end of treatment)

• Overall Survival (OS)

  From enrollment to End of follow-up (up to 6 months post end of treatment)

• Quality of life composite index

  From enrollment to 30 days post the last dose of ACM-CpG

Study Arms (1)

ACM-CpG

EXPERIMENTAL

Drug: ACM-CpG

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

ACM-CpG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients age ≥ 18 years of age at the time of informed consent
• 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
• 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
• Must have evaluable disease by physical examination, serum tumor markers, radiologic assessment, or laparoscopic visual assessment
• Must have a life expectancy of ≥ 12 weeks as estimated by the investigator
• Must have an ECOG status of ≤ 2
• Patients with acceptable laboratory values defined as:
• Estimated creatinine clearance (calculated using Cockcroft-Gault formula, or measured) ≥ 60 mL/min, not dialysis dependent
• Total bilirubin ≤ 1.5 mg/dl, unless elevated bilirubin is clearly related to Gilbert syndrome (and total bilirubin \< 6.0 mg/dl)
• Alanine aminotransferase (ALT) ≤ 3.5 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST) ≤ 3.5 x ULN
• Absolute neutrophil count \> 1.0 x 109/L (must be independent of blood product administration)
• Platelet count \> 100 x 109/L (must be independent of blood product administration)
• Hemoglobin ≥ 8 g/dL (must be independent of blood product administration)
• Surgically sterile patients or patients of childbearing potential (CBP) who agree to use highly effective methods of contraception during study dosing and for 6 months after last dose of study drug

You may not qualify if:

• Has received prior TLR9 therapy
• Has received chemotherapy, radiotherapy, or biological cancer therapy within 21 days or 5 half-lives (whichever is shorter) of the start of treatment
• Has received an investigational agent within 28 days of the start of treatment
• Has received a commercial vaccine (flu, COVID, etc.) within 2 weeks of C1D1
• Has any unresolved toxicity ≥ Grade 2 from previous anti-cancer therapy, except for stable chronic toxicities (≤ Grade 3) that are not expected to resolve
• Has a history of histologically confirmed metastases outside of the peritoneal cavity, liver, or lungs
• 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
• Tumor causing biliary obstruction not amenable to stenting or percutaneous drainage
• Ongoing or untreated intra-abdominal infection or bowel obstruction
• Has known, clinically active Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV) (Note: Testing is not required)
• Receiving continuous systemic corticosteroid therapy (≥ 10 mg/day of prednisolone or equivalent)
• Clinically significant cardiac disease or impaired cardiac function, including any of the following:
• A history of newly diagnosed transmural myocardial infarction, cerebral infarction, or pulmonary embolism within 6 months, except those approved by the medical monitor
• A history of newly diagnosed deep vein thrombosis (DVT) within 3 months
• Left ventricular ejection fraction (LVEF) \< 50%

Sponsors & Collaborators

• Brown University: lead

Study Sites (1)

Rhode Island and the Miriam Hospitals (Brown University Health)

Providence, Rhode Island, 02903/02906, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Neoplasms; Adenocarcinoma, Mucinous; Peritoneal Neoplasms

Interventions

ACM-001 COVID-19 vaccine

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Cystic, Mucinous, and Serous; Abdominal Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Study Officials

• Khaldoun Almhanna, MD

  Brown University Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roxanne Wood

CONTACT

401-863-3000; roxanne_wood@brown.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3+3 dose escalation

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: June 18, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2030
• Last Updated: June 18, 2026

Record last verified: 2026-06

Locations

US (1)