Trial of NanoPac® in Subjects With Locally Advanced Pancreatic Adenocarcinoma

Open-label, dose-escalating, Phase IIa trial of NanoPac® to treat subjects with locally advanced pancreatic adenocarcinoma via direct intratumoral injection.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* Signed informed consent;
* Age ≥18 years;
* Histologically/cytologically confirmed locally advanced pancreatic adenocarcinoma; at least one lesion with a diameter of at least 1.5 cm but no more than 6 cm as documented via imaging (within 6 weeks of Screening);
* Subject not a candidate for surgery;
* Completion of at least one standard of care IV chemotherapy course for subjects in the dose escalation phase of the study. IV chemotherapy will be initiated prior to first NanoPac injection for subjects in the second and third phases. Hematologic recovery must be confirmed prior to study entry;
* Performance Status (ECOG) 0-1 at study entry;
* Life expectancy of at least 3 months;
* Adequate marrow, liver, and renal function at study entry:

  * ANC ≥ 1.5 x 109/L
  * Hemoglobin ≥ 9.5 grams/dL
  * Platelets ≥ 75 x 109/L
  * Total bilirubin ≤ 1.5x institutional ULN
  * AST/ ALT ≤ 2.5x institutional ULN
  * Creatinine ≤ 1.5x institutional ULN
* Effective contraception if the risk of conception exists.

Exclusion Criteria:

* Thrombotic or embolic events;
* Acute or subacute intestinal occlusion;
* History of inflammatory bowel disease;
* Known hypersensitivity to study drugs;
* Known drug or alcohol abuse;
* Pregnant or breastfeeding women;
* Previous or concurrent history of non-pancreatic malignancy except for non-melanoma skin cancer.

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• BACKGROUNDTaxol® (paclitaxel) Injection Package Insert. Bristol-Myers Squibb Company. Rev July 2011.
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• BACKGROUNDVon Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16. PMID 24131140
• DERIVEDSharma NR, Lo SK, Hendifar A, Othman MO, Patel K, Mendoza-Ladd A, Verco S, Maulhardt HA, Verco J, Wendt A, Marin A, Schmidt CM, diZerega G. Response of Locally Advanced Pancreatic Cancer to Intratumoral Injection of Large Surface Area Microparticle Paclitaxel: Initial Report of Safety and Clinical Outcome. Pancreas. 2023 Mar 1;52(3):e179-e187. doi: 10.1097/MPA.0000000000002236. PMID 37782888