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About
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
Full description
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.
Enrollment
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Inclusion criteria
Males or females > 18 years of age
If female, must not be pregnant or nursing; women of child-bearing potential must practice a medically approved method of contraception
If male, must practice a medically approved method of contraception if have a partner of childbearing potential
Histologically or cytologically confirmed adenocarcinoma of the exocrine pancreas
Locally advanced pancreatic cancer (LAPC) that is clinically unresectable as defined in the NCCN Guidelines
Karnofsky performance status (KPS) ≥ 70% at baseline
Adequate hematological, renal, and hepatic function
Have a target tumor lesion in the pancreas ≤ 6 cm in diameter that is accessible for intratumoral administration by EUS guidance as determined by the physician performing the EUS injection
Have a biopsy specimen that is positive for H19 expression (grade 2 or greater staining determined by a pathologist). H19 expression can be determined based on a biopsy specimen collected before study participation, if available.
No prior diagnosis of malignancy within 3 years except for curatively treated non-melanoma skin or in situ malignancies
Able to comply with the protocol procedures
Able and willing to provide written (signed) Informed Consent to participate in the study
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
12 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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