Phase IIa Trial Evaluating the Safety of Intratumoral Injection of NanoPac® in Subjects With Locally Advanced Pancreatic Adenocarcinoma

NANOPAC-2016-05

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

2017-12-01

2023-03-15

2023-03-15

Completed

Early phase I

54

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Open-label, dose-escalating, Phase IIa trial. Subjects will be enrolled in sequential cohorts of NanoPac® at a volume up to 20% of tumor volume (maximum injection volume of 5 mL per subject). Each cohort will have 3 subjects, with cohorts enrolled sequentially starting at the lowest concentration. Following DSMB review of the cohort data, the next cohort may begin enrolling. The highest dose with an acceptable safety and tolerability profile will be the dose used in the second phase of the study which will enroll 22 additional subjects to receive 2 NanoPac® injections one month apart and 30 additional subjects to receive 4 NanoPac® injections one month apart.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 54, 'type': 'ACTUAL'}}

2023-11-08