Clinical Research Directory

PHASE 1 TRIAL OF Lm-LLO-TT AND GEMCITABINE IN UNRESECTABLE PANCREATIC DUCTAL ADENOCARCINOMA

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.

Phase 1/2 Dose Finding, Safety and PK Study in Advanced Refractory Solid Tumors

This is a multicenter, open-label FIH, Phase 1a (dose escalation), Phase 1b (dose expansion) and Phase 2 study in patients with advanced metastatic solid tumors refractory to standard treatment.

A Study of mRNA Vaccines AK154 Monotherapy or in Combination With AK104/AK112,and Sequential mFOLFIRINOX in Surgically Resected PDAC

To explore safety and efficacy of neoantigen personalized mRNA vaccines AK154 monotherapy or in combination with AK104/AK112 and sequential mFOLFIRINOX regime in Resected PDAC