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NCT07658196 · ClinicalTrials.gov registry record · Phase 1

TLR9 Immunotherapy for Peritoneal Carcinomatosis

A Phase 1 study, sponsored by Brown University.

Not yet
Registry status
Phase 1
Development phase
24
Enrollment target

NCT07658196: Clinical Trial Phase 1 study, sponsored by Brown University.

NCT07658196 is a Phase 1 study that has not yet begun recruiting, run by Brown University. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07658196, a Phase 1 study, has not yet begun recruiting, sponsored by Brown University.

NOT YET RECRUITING
Registry status
Phase 1
Development phase
24 participants
Enrollment target

Study 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.

Primary Outcome

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

Interventions

  • DRUG ACM-CpG

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2026-07
Est. Completion 2030-07
Phase Phase 1
Brown University

231 total trials

What is known before NCT07658196 opens enrollment

NCT07658196 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).

The record links to 0 conditions, and to 1 intervention - of which ACM-CpG is the first listed.

NCT07658196 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07658196 about?

NCT07658196 is a clinical study titled "TLR9 Immunotherapy for Peritoneal Carcinomatosis". 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 inj...

What is the current status of trial NCT07658196?

This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2026-07. Estimated completion is 2030-07.

What interventions are being tested in trial NCT07658196?

The interventions under investigation include: ACM-CpG (DRUG).

Who is sponsoring clinical trial NCT07658196?

This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07658196's enrollment target sits among peer trials

24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07658196, the US trial registry maintained by the National Library of Medicine. NCT07658196 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.