Lm-LLO-TT + Gemcitabine for Pancreatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
ClinicalTrials.gov Brief Summary
This Phase 1, open-label, first-in-human study is designed to evaluate the safety, tolerability, and recommended dose of intraperitoneal (IP) administration of Lm-LLO-TT in combination with low-dose gemcitabine in adults with previously treated, unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC). Up to 18 participants will be enrolled.
Lm-LLO-TT is a live attenuated Listeria monocytogenes-based immunotherapy engineered to express a tetanus toxoid antigen. The study will assess the safety of administering Lm-LLO-TT directly into the peritoneal cavity and characterize its use in combination with low-dose gemcitabine.
Eligible participants will receive a tetanus toxoid booster vaccination during screening and undergo placement of an intraperitoneal access port before treatment. Participants will receive a single loading dose of Lm-LLO-TT followed by five cycles of low-dose gemcitabine and low-dose Lm-LLO-TT administered over approximately 17 days. Participants will be monitored for adverse events, laboratory abnormalities, dose-limiting toxicities, and disease outcomes throughout the study.
The primary objective is to assess safety and tolerability and to determine the maximum tolerated dose and recommended dose for future clinical studies. Secondary objectives include evaluation of anti-tumor activity. Exploratory objectives include assessment of immune biomarkers, changes in pancreatic cancer-related symptoms, and changes in pain medication use.
Participants will undergo tumor imaging assessments following treatment and during follow-up. A post-treatment tumor biopsy will be required for the first 10 enrolled participants and optional for subsequent participants. Participants will be followed for safety, disease status, and survival for up to 6 months after treatment initiation.
Are You a Good Fit for This Trial?
This trial is for adults with pancreatic ductal adenocarcinoma that cannot be removed by surgery or has spread, and who have already received other treatments. Participants must be able to get a tetanus booster shot and have an access port placed in their abdomen.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Lm-LLO-TT
Trial Overview
The study tests the safety of giving Lm-LLO-TT (a modified bacteria-based immunotherapy) directly into the belly along with low-dose gemcitabine chemotherapy. Up to 18 people will receive these treatments over about 17 days, followed by monitoring.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Middle dose
Low dose
Find a Clinic Near You
Who Is Running the Clinical Trial?
Loki Therapeutics, Inc.
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
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