A Phase 2 Study to Evaluate the Efficacy and Safety of Ampligen® Compared to Control Group / No Treatment Following FOLFIRINOX in Subjects with Locally Advanced Pancreatic Adenocarcinoma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Aim Immunotech Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2024-12-05

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-518627-29-00

EudraCT number

2022-002383-68

ClinicalTrials.gov

NCT05494697

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To compare the efficacy of Ampligen® versus Control group / no treatment following FOLFIRINOX in subjects with Locally Advanced Pancreatic Adenocarcinoma.

Conditions and MedDRA coding

locally advanced pancreatic cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Subjects will be eligible for enrollment in the study only if they meet ALL the following criteria at time of Screening: 1. Histological diagnosis of pancreatic adenocarcinoma confirmed pathologically: Unresectable pancreatic cancer; locally advanced pancreatic cancer. 2. Measurable disease per RECIST v.1.1. 3. Completion of at least four (4) months of first line FOLFIRINOX treatment and no disease progression per RECIST v.1.1 as confirmed by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan 4 to 12 weeks after last FOLFIRINOX treatment. 4. Male or non-pregnant, non-lactating female, ≥18 years or age. 5. Negative pregnancy test for female subjects. Women of child-bearing potential (WOCBP) and Women not of child-bearing potential are eligible to participate. Both women of child-bearing potential and women of non child-bearing potential should use an approved method of birth control and agrees to continue to use this method for the duration of the study and for 90 days after last treatment. Acceptable methods of contraception include abstinence, female subject/partner's use of hormonal contraceptive (oral, implanted, or injected) in conjunction with a barrier method (WOCBP only), female subject/partner's use of an intrauterine device (IUD), or if the female subject/partner is surgically sterile or two years post-menopausal. All male subjects/partners must agree to use a condom consistently and correctly for the duration of the study and for 90 days after last treatment. In addition, subjects may not donate sperm for the duration of the study and for 90 days after last treatment. Females who are less than two (2) years post-menopausal, those with tubal ligations and those using contraception must have a negative serum pregnancy test at baseline within the one (1) week prior to the first study medication infusion. Every six weeks, and at study termination a pregnancy test should be performed, either serum or urine stick test. However, if the urine result is positive, a serum pregnancy test will be performed. Any pregnancy that occurs while taking Ampligen® should be recorded using a Pregnancy Report Form and reported immediately to AIM ImmunoTech Inc. 6. Provide signed written informed consent and willingness, ability to comply with study requirements. 7. Minimum weight of 40kg at baseline. 8. Karnofsky Performance Status of 80 or higher at baseline. 9. Subject must have a projected life expectancy of ≥ 3 months in the opinion of the Investigator. 10. Subject has adequate organ function by the following laboratory assessments at baseline (obtained ≤ 21 days prior to Randomization): Hematologic: Platelets ≥ 100×109/L Hemoglobin ≥ 9.0 g/dL Absolute Neutrophil Count (ANC) ≥ 1.5×109/L Absolute lymphocyte count ≥ 3 x 109/L Hepatic: AST/ALT ≤ 3×ULN (if liver metastases are present, ≤ 5×ULN) Alkaline phosphatase ≤ 2.0×ULN (if liver metastases are present, ≤ 5×ULN) Total bilirubin ≤ 1.5×ULN Albumin ≥ 3.0 g/dL Renal: Creatinine clearance ≥ 60 mL/min using the Cockcroft-Gault formula. Coagulation PT-INR and APTT within normal limits

Exclusion criteria 1

1. meeting ANY of the following criteria at time of Screening will be excluded from enrollment: 1. Diagnosis of islet neoplasm acinar cell carcinoma, non-adenocarcinoma (i.e., lymphoma, sarcoma),adenocarcinoma originating from the biliary tree, or cystadenocarcinoma. 2. Subjects who have surgically resectable locally advanced pancreatic adenocarcinoma following treatment withFOLFIRINOX. 3. Subject has received prior treatment with Ampligen®. 4. Therapy with investigational drugs within 6 weeks of beginning study medication. 5. History of prior malignancy, except for adequately treated in situ cancer, basal cell, squamous cell skin cancer,or other cancers (e.g., breast, prostate) for which the subject has been disease-free for at least 3 years. Subjectswith prior cancer that is adequately controlled per the judgement of the Investigator will not be excluded from thestudy. 6. Any serious medical condition, laboratory abnormality, psychiatric illness, or comorbidity that, in the judgment ofthe Investigator, would make the subject inappropriate for the study. 7. Serious systemic fungal, bacterial, viral, or other infection that is not controlled or requires intravenous (IV)treatment for infection(s). 8. Known history of positivity (regardless of immune status) for human immunodeficiency virus (HIV). 9. Known history of, chronic active, or active viral hepatitis A, B, or C infection 10. Clinically significant bleeding within 2 weeks prior to Randomization (e.g., gastrointestinal [GI] bleeding,intracranial hemorrhage). 11. Pregnant or lactating women. 12. Myocardial infarction within the last 6 months prior to Randomization, symptomatic congestive heart failure(New York Heart Association Classification > Class II), unstable angina, or unstable cardiac arrhythmia requiringmedication. 13. Subjects with abnormal electrocardiogram (ECG) at baseline QTc interval >470 ms. Both Bazett’s andFridericia’s corrections need to be applied; if either is >470 ms; subject is not eligible. 14. Subjects with positive germline BRCA (gBRCA) mutations. 15. Clinically significant ascites defined as requiring ≥ 1 paracentesis every 2 weeks. 16. Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision(i.e., larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy),within 28 days prior to Randomization or anticipated surgery during the study period. 17. Prior history of receiving immune checkpoint inhibitors (anti-CTLA4, anti-PD1, anti-PD- L1). 18. Inability to return for scheduled treatment and assessments.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Progression Free Survival (PFS) [Time Frame: Visit 2/ First Treatment until disease progression, death, or end of study up to 42 months] PFS is defined as the time, in months, from date of Visit 2/ First Treatment to date of the first documentation of definitive disease progression as per RECIST v1.1 (the initial progressive disease (PD)) or death due to any cause.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Aim Immunotech Inc.

Sponsor organisation

Aim Immunotech Inc.

Address

2117 Southwest Highway 484

City

Ocala

Postcode

34473-7949

Country

United States

Scientific contact point

Organisation

Aim Immunotech Inc.

Contact name

Diane Young

Public contact point

Organisation

Aim Immunotech Inc.

Contact name

Diane Young

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 3 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications