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PHASE 1, OPEN-LABEL, FIRST-IN-HUMAN TRIAL OF INTRAPERITONEA L Lm-LLO-TT AND GEMCITABINE IN PARTICIPANTS WITH UNRESECTABLE PANCREATIC DUCTAL ADENOCARCINOMA
Sponsor study identifier
interventional
18
1 country
1
Study Start
October 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 15, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 14, 2026
Actual (reported)September 18, 2026
Actual (reported)October 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 15, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Safety and tolerability
Incidence of dose-limiting toxicities (DLTs) and treatment-emergent adverse events to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of intraperitoneal Lm-LLO-TT in combination with low-dose gemcitabine
Day 1 to Day 45
Objective Response Rate
Up to 6 months
Disease Control Rate (DCR)
Day 1 to 6 months
Low dose
Middle dose
Lm-LLO-TT is a live attenuated Listeria monocytogenes-based immunotherapy expressing tetanus toxoid and listeriolysin O, developed to stimulate tumor-directed immune responses through activation of tetanus-specific memory T cells.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Einstein College of Medicine/Montefiore Hospital
The Bronx, New York, 10461, United States
First Submitted
September 14, 2026
First Posted
September 18, 2026
Study Start
October 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 15, 2028
EstimatedProgression-Free Survival (PFS)
Day 1 to 6 months
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 18, 2026
Record last verified: 2026-09
Individual participant data (IPD) collected during this study, including de-identified participant-level data and supporting study documents, will not be made available to other researchers. The study is an early-phase, first-in-human clinical trial of a proprietary investigational product and no plan currently exists for sharing individual participant data.
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Source: ClinicalTrials.gov.
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