Trial of NanoPac® in Subjects With Locally Advanced Pancreatic Adenocarcinoma

In this open-label, dose-escalating, Phase IIa trial, subjects with locally advanced

pancreatic adenocarcinoma will receive intratumoral (ITU) NanoPac® (Sterile

Nanoparticulate Paclitaxel) via endoscopic ultrasound-guided direct injection.

Subjects will be enrolled in sequential cohorts of NanoPac® at escalating doses, at a

volume based on up to 20% of calculated tumor volume (with a maximum injection volume of

5 mL per subject). During the first phase of the trial (dose escalation), each cohort

will have three subjects, with cohorts enrolled sequentially starting at the lowest

concentration. Following DSMB review of the cohort data, the next cohort may begin

enrolling, an additional three subjects at the current dose may be enrolled, or if the

first dose does not provide adequate safety and tolerability the study may be halted.

The dose determined to be most suitable for further evaluation, defined as the highest

dose with an acceptable safety and tolerability profile as determined by the Data Safety

Monitoring Board (DSMB), will be the dose used in the second phase of the study which

will enroll 22 additional subjects who will receive two injections of NanoPac® at the

same dose one month apart. In the third phase of the study, up to 30 subjects will

receive up to four injections of NanoPac at the same dose, one month apart.

Plasma samples will be taken at various time points on the day of NanoPac® injection as

well as once at each of the study visits, to characterize the pharmacokinetics (PK) of

ITU NanoPac®.

Subjects will be followed for 12 months after NanoPac® injection for safety, overall

survival (OS), progression-free survival (PFS), CA-19-9 levels, carcinoembryonic antigen

(CEA) levels, reduction in pain, and tumor response to therapy (as shown by imaging).