Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingPhase 1interventionalRules rewrite

Phase 1: testing Lm-LLO-TT for Pancreas Cancer, Duct Cell Adenocarcinoma

ClinicalTrials.gov Brief Summary This Phase 1, open-label, first-in-human study is designed to measure 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). Lm-LLO-TT is a live attenuated Listeria monocytogenes-based immunotherapy engineered to express a tetanus toxoid antigen.

Official registry: https://clinicaltrials.gov/study/NCT07828236 · Loki Therapeutics, Inc. · enrollment listed as 18

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Lm-LLO-TT. The registry lists allocation as randomized. ClinicalTrials.gov Brief Summary This Phase 1, open-label, first-in-human study is designed to measure 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).

They plan to enroll about 18 people at The Bronx. Taking part typically means an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

Phase 1, Open-Label, First-In-Human Trial of Intraperitoneal Lm-LLO-TT And Gemcitabine in Participants With Unresectable Pancreatic Ductal Adenocarcinoma

Interventions: Lm-LLO-TT

Primary outcome (registry wording): Safety and tolerability

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Previously treated with at least one line of chemotherapy for metastatic or unresectable disease, including a fluoropyrimidine-based or gemcitabine-based regimen, or have a contraindication to these therapies
  • No radiation therapy, targeted therapy, or chemotherapy within 14 days prior to first study treatment; no immunotherapy or biologic therapy within 28 days prior to first study treatment
  • Recovery to ≤ Grade 2 from clinically significant toxicities of prior therapy. how well you can do daily activities (ECOG score) 0-2. Estimated life expectancy greater than 3 months. Adequate organ function, including adequate hematologic, hepatic, and renal function
  • Participants with treated brain metastases may be enrolled if clinically stable for at least 1 month
  • Participants with hepatitis B may be enrolled if viral load is undetectable and appropriately treated; participants with hepatitis C may be enrolled following curative treatment
  • Demonstrated tetanus toxoid (TT) immune responsiveness, either at baseline or following administration of a tetanus toxoid booster during screening

Public study contact (from the registry)

Corrina Pavetto, Clinical Operations Director

2023215786

cpavetto@clinregconsults.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT07828236 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07828236?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07828236?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary