RecruitingPhase 1

TLR9 Immunotherapy for Peritoneal Carcinomatosis

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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?"
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests ACM-CpG, a treatment injected into the space around the organs in the belly. Researchers want to learn how safe it is, how well it works, and the best dose. It is for adults with colon, rectal, or appendix cancer that has spread to the belly lining or caused cancer-related fluid buildup and cannot be treated with surgery.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older, give written consent, and agree to follow study requirements.
  • Have confirmed colon, rectal, or appendix cancer involving the belly lining or causing cancer-related fluid buildup. Limited spread to the liver or lungs is allowed.
  • Have cancer that can be checked by an exam, blood tests, scans, or a camera placed inside the belly.
  • Be expected to live at least 12 weeks.
  • Be able to care for yourself and be out of bed or a chair for more than half of waking hours.
  • Meet the study’s kidney, liver, and blood count limits, and not need dialysis, a treatment that filters the blood.
  • Be unable to have children because of surgery, or agree to use highly effective birth control during treatment and for 6 months after the last dose.
  • Have other health conditions well controlled and stable for at least 28 days before treatment.

Who can't join

  • Past TLR9 treatment or an allergic reaction to TLR9 drugs, the type of treatment tested here.
  • Recent cancer treatment within 21 days, or a shorter time based on how long the drug stays in the body; an experimental drug within 28 days; or a routine vaccine within 2 weeks.
  • Moderate or worse side effects from past cancer treatment, except certain stable, long-term effects that are not expected to go away.
  • Confirmed cancer spread outside the belly lining, liver, or lungs; cancer replacing more than half the liver; or more than 5 lung tumors larger than 1 centimeter.
  • A tumor blocking bile flow that cannot be relieved with a tube or drain, a blocked bowel, or an ongoing or untreated infection inside the belly.
  • An active bacterial, viral, or fungal infection, including active hepatitis B, hepatitis C, or HIV; or ongoing steroid medicine equal to at least 10 mg of prednisolone daily. Infection-prevention drugs alone do not rule you out.
  • Serious heart problems, certain recent blood clots, heart attack, or stroke; another active cancer within 2 years except certain skin cancers; or another condition that makes participation unsafe or affects study results.
  • Being pregnant, likely to become pregnant, or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Patients eligible for inclusion in this study must meet all of the following criteria: 1. Male or female patients age ≥ 18 years of age at the time of informed consent 2. 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 3. 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 4. Must have evaluable disease by physical examination, serum tumor markers, radiologic assessment, or laparoscopic visual assessment 5. Must have a life expectancy of ≥ 12 weeks as estimated by the investigator 6. Must have an ECOG status of ≤ 2 7. 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) 8. 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 9. 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 Exclusion Criteria: 1. Has received prior TLR9 therapy 2. Has received chemotherapy, radiotherapy, or biological cancer therapy within 21 days or 5 half-lives (whichever is shorter) of the start of treatment 3. Has received an investigational agent within 28 days of the start of treatment 4. Has received a commercial vaccine (flu, COVID, etc.) within 2 weeks of C1D1 5. Has any unresolved toxicity ≥ Grade 2 from previous anti-cancer therapy, except for stable chronic toxicities (≤ Grade 3) that are not expected to resolve 6. Has a history of histologically confirmed metastases outside of the peritoneal cavity, liver, or lungs 7. 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 8. Tumor causing biliary obstruction not amenable to stenting or percutaneous drainage 9. Ongoing or untreated intra-abdominal infection or bowel obstruction 10. Has known, clinically active Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV) (Note: Testing is not required) 11. Receiving continuous systemic corticosteroid therapy (≥ 10 mg/day of prednisolone or equivalent) 12. 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% * QTc \>480 msec 13. Active bacterial, viral, or fungal infection: patients with ongoing use of prophylactic antibiotics, antiviral agents, or antifungal agents remain eligible as long as there is no evidence of active infection 14. Other active malignancy within 2 years excluding cutaneous squamous or basal cell carcinomas 15. Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results 16. History of hypersensitivity to TLR9 agonists 17. Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation)

Study sites (1)

RI