Following an FDA investigational new drug application and protocol approval, the phase 2 study of AMP-270 and rintatolimod in patients with advanced pancreatic cancer has begun.
Approximately 90 patients with advanced pancreatic cancer will soon be enrolled in a phase 2, randomized, open-label, controlled, parallel arm study of AMP-270 and rintatolimod (NCT05494697).1,2
The study aims to evaluate the efficacy and safety of AMP-270 vs a control arm of no treatment following irinotecan, fluorouracil, folinic acid, and oxaliplatin (FOLFIRINOX) until evidence of disease progression. The start of the study follows the FDA’s clearing of an investigational new drug application for AMP-270 and approval of the trial’s protocol by the Institutional Review Board (IRB).1
Trial Name: Phase 2, Randomized, Open-Label, Controlled Study to Evaluate the Efficacy and Safety of Ampligen® Compared to Control Group / No Treatment Following FOLFIRINOX in Subjects With Locally Advanced Pancreatic Adenocarcinoma
ClinicalTrials.gov Indentifier: NCT05494697
Completion Date: January 2027
Recruitment Status: Not yet recruiting
Sponsor: AIM ImmunoTech Inc.
“We are pleased to reach this important step in the development of Ampligen. Receiving IRB approval for our phase 2 study of Ampligen for the treatment of LAPC is the pivotal precursor to the recruitment, enrollment, and treatment of patients with locally advanced pancreatic cancer. We look forward to providing further updates on the development of this important therapy,” said Thomas K. Equels, chief executive officer of AIM ImmunoTech, Inc (AIM), in a press release.
In the study, patients in the experimental arm will receive AMP-270 in combination with up to a 400 mg intravenous dose of rintatolimod twice daily. The primary end point of the study is progression-free survival, and the secondary end points are overall survival, objective response rate, and duration of response.2
Eligible patients are those aged 18 years or older with a pathologically confirmed histological diagnosis of pancreatic adenocarcinoma, measurable disease per RECIST v1.1, a Karnofsky performance score of 80 or higher, a life expectancy of at least 3 months, adequate organ function, and who weigh at least 40 kilograms. All patients must have completed at least 4 months of treatment with the FOLOFIRNOX regimen and have no disease progression for 4 weeks after the last dose. Female patients are required to have a negative pregnancy test and use contraception during the study.
Patients will be excluded from the study if they have a diagnosis of islet neoplasm acinar cell carcinoma, non-adenocarcinoma, adenocarcinoma originating from the biliary tree, or cystadenocarcinoma. Patients with a history of a primary malignancy other than in situ cancer, basal cell, squamous cell skin cancer, or other cancers must be disease-free for 3 years or are ineligible. Other serious diseases or infections that may interfere with study treatment are grounds for exclusion.
Certain prior therapies including surgical resection following FOLFIRINOX, treatment with AMP-270, investigational drugs within 6 weeks of the start of the study, major surgery within 28 days of randomization, and prior treatment with immune checkpoint inhibitors are mentioned in the exclusion criteria. Further, a positive germline BRCA mutation during testing would make a patient ineligible for the study.
The study has not yet begun recruiting eligible patients with advanced pancreatic cancer. According to the research organization contracted by AIM, sites will open and start recruiting patients at the end of the third quarter or in the early fourth quarter of 2022.1
REFERENCES:
1. AIM ImmunoTech announces commencement of phase 2 study of Ampligen® for the treatment of pancreatic cancer. News release. Aim ImmunoTech. August 18, 2022. Accessed August 22, 2022. https://bit.ly/3PI3HY6
2. Ampligen compared to no treatment following FOLFIRINOX in subjects with locally advanced pancreatic adenocarcinoma. ClinicalTrials.gov. Updated August 10, 2022. Accessed August 22, 2022. https://clinicaltrials.gov/ct2/show/NCT05494697?term=NCT05494697&draw=2&rank=1
