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
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.
• Patients eligible for inclusion in this study must meet all of the following criteria:
‣ 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
⁃ All other relevant medical conditions must be well-managed and stable, in the opinion of the investigator, for at least 28 days prior to administration of study drug