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.
None
History of chronic comorbidities that would significantly limit participation in the study, including severe heart failure (NYHA Class III-IV), end-stage renal disease, substance dependence, or inadequate venous access, as determined by the investigator.
Single group
Lm-LLO-TT
Biological/VaccineLm-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.
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
Objective Response Rate
Percentage of participants with complete response or partial response as assessed by RECIST v1.1.
Disease Control Rate (DCR)
Percentage of participants with complete response, partial response, or stable disease as assessed by RECIST v1.1.
Progression-Free Survival (PFS)
Time from first study treatment to documented disease progression or death.
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Loki Therapeutics, Inc.
Lead sponsor
National Cancer Institute (NCI)
Collaborator
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