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.
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
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
Sequential
ACM-CpG
DrugThe 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
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
Progression Free Survival (PFS)
Disease control rate (DCR)
The percentage of patients who have achieved complete response, partial response and stable disease
Overall Survival (OS)
Quality of life composite index
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