Pancreas, Adenocarcinoma Clinical Trial
Official title:
A Multi-Center, Open-Label, Randomized, Phase 2b Study to Evaluate the Efficacy and Safety of BC-819 and Gemcitabine in Patients With Locally Advanced Pancreatic Adenocarcinoma
This is a multicenter, open label, randomized, phase 2b study, designed to evaluate the
safety and efficacy of patients with locally advanced pancreatic adenocarcinoma following
intratumoral administration of BC-819 and intravenously administered gemcitabine.
Intratumoral injections of BC-819 will be performed using endoscopic ultrasound (EUS).
Primary Objective: To assess the effect of intratumoral endoscopic ultrasound injection of
BC-819 administered with intravenous gemcitabine on progression-free survival.
Secondary Objectives: To compare the effects of intratumoral injection of BC-819 administered
in combination with intravenous gemcitabine vs. intravenous gemcitabine alone on:
Overall survival, Response rate, Resectability of the target tumor lesion, Quality of life,
Safety, Serological Tumor Marker: CA 19-9, Duration of response, Failure-free survival
BC-819 (also known as DTA-H19) is a double-stranded DNA plasmid, 4,560 base pairs (bp) in length, carrying the gene for the Diphtheria toxin A (DT-A) chain under the regulation of the H19 promoter. This is a Targeted Cancer Therapy; DT-A chain expression is triggered by the presence of H19 transcription factors that are only up-regulated in tumor cells. The selective initiation of toxin expression results in selective tumor cell destruction via inhibition of protein synthesis selectively in the tumor cell, enabling highly targeted cancer treatment. ;