Ampligen Combined With SOC Versus SOC Alone Following First-Line Therapy in Subjects With LAPC

NCT05494697 | Suspended Phase 2 DMC FDA Drug

• 1 other identifier: AMP-270
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to assess the safety and efficacy of Ampligen in patients with locally advanced pancreatic adenocarcinoma

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  PFS is defined as the time, in months, from date of randomization to date of the first documentation of definitive disease progression as per RECIST v1.1 and iRECIST (the initial progressive disease (PD)) or death due to any cause.

  Randomization until disease progression, death, or end of study up to 182 weeks

Secondary Outcomes (4)

• Overall Survival (OS)

  Randomization to death due to any cause, or end of study up to 182 weeks.

• Overall Survival (OS) at 1 year

  Randomization to death due to any cause.at 1 year

• Objective Response Rate (ORR)

  Randomization until disease progression, death, or end of study up to 182 weeks

• Duration of Response (DoR)

  Randomization until disease progression, death, or end of study up to 182 weeks

Study Arms (4)

Ampligen / rintatolimod + SOC Chemoradiation

EXPERIMENTAL

Subjects will receive rintatolimod \[intravenous (IV)\], up to 400 mg twice weekly plus SOC chemoradiation until disease progression

Drug: Rintatolimod

SOC Chemoradiation Alone

NO INTERVENTION

Subjects will receive SOC chemoradiation until evidence of disease progression.

Ampligen / rintatolimod + SOC

EXPERIMENTAL

Subjects will receive rintatolimod \[intravenous (IV)\], up to 400 mg twice weekly plus SOC (SOC does not include chemoradiation) until disease progression

Drug: Rintatolimod

SOC Alone

NO INTERVENTION

Subjects will receive SOC (SOC does not include chemoradiation) until evidence of disease progression.

Interventions

Rintatolimod DRUG

Rintatolimod (poly I : poly C12U)

Also known as: Ampligen, poly I : poly C12U

Ampligen / rintatolimod + SOC; Ampligen / rintatolimod + SOC Chemoradiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological diagnosis of pancreatic adenocarcinoma confirmed pathologically: Unresectable pancreatic cancer; locally advanced pancreatic cancer.
• Measurable disease per RECIST v.1.1.
• Completion of at least four (4) months of first line therapy, such as FOLFIRINOX and no disease progression per RECIST v.1.1 as confirmed by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan after last first-line therapy and prior to randomization.
• Subject must meet one of the following criteria for stratification question of 'Is subject planned to receive chemoradiation therapy as SOC? \[Yes/No\]' A. For subjects to be enrolled under stratification of 'Yes, SOC includes chemoradiation', subjects are planned to receive the following allowable radiotherapy and chemotherapy, with curative intent (i.e., not palliative).
• Allowable SOC radiotherapy:
• IMRT (Intensity-Modulated Radiation Therapy)
• SBRT (Stereotactic Body Radiation Therapy)
• Allowable SOC chemotherapy:
• Capecitabine
• Fluorouracil (5-FU) +/- irinotecan B. For subjects to be enrolled under stratification of 'No, SOC does not include chemoradiation', subjects are planned to receive chemotherapy alone or undergo surveillance for disease progression only.
• Male or non-pregnant, non-lactating female, ≥18 years or age.
• Negative serum pregnancy test at screening visit for female subjects of childbearing potential. Females of childbearing potential must be willing to use an acceptable method of contraception from screening up until 90 days after last study treatment administration.
• Acceptable methods of contraception include abstinence, female subject/partner's use of hormonal contraceptive (oral, patch, injectable, depot or vaginal) in conjunction with a barrier method (e.g., diaphragm, cervical cap, condom, spermicide or sponge), or female subject/partner's use of an implantable device (implantable rod or intrauterine device).
• Female subject/partners of non-childbearing potential are defined as surgically sterile (e.g., bilateral tubal ligation, hysterectomy) or two years postmenopausal at time of screening.
• All male subjects (excluding men who have been sterilized) with female partners of child-bearing potential must agree to consistently and correctly use a condom from screening up until 90 days after last study treatment administration. In addition, subjects may not donate sperm for the same time period.

You may not qualify if:

• Diagnosis of islet neoplasm acinar cell carcinoma, non-adenocarcinoma (i.e., lymphoma, sarcoma), adenocarcinoma originating from the biliary tree, or cystadenocarcinoma.
• Subjects who have surgically resectable locally advanced pancreatic adenocarcinoma following treatment with first-line therapy, such as FOLFIRINOX.
• Subject has received prior treatment with Ampligen®.
• Therapy with investigational drugs within 6 weeks of beginning study medication.
• 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. Subjects with prior cancer that is adequately controlled per the judgement of the Investigator will not be excluded from the study.
• Any serious medical condition, laboratory abnormality, psychiatric illness, or comorbidity that, in the judgment of the Investigator, would make the subject inappropriate for the study.
• Serious systemic fungal, bacterial, viral, or other infection that is not controlled or requires intravenous (IV) treatment for infection(s).
• Known history of positivity (regardless of immune status) for human immunodeficiency virus (HIV).
• Known history of, chronic active, or active viral hepatitis A, B, or C infection
• Clinically significant bleeding within 2 weeks prior to Randomization (e.g., gastrointestinal \[GI\] bleeding, intracranial hemorrhage).
• Pregnant or lactating women.
• 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 requiring medication.
• Subjects with abnormal electrocardiogram (ECG) at screening with QTc interval \>470 ms (calculated using both the Bazett's and Fridericia's corrections).
• Clinically significant ascites defined as requiring ≥ 1 paracentesis every 2 weeks.
• 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.

Sponsors & Collaborators

• AIM ImmunoTech Inc.: lead
• Amarex Clinical Research: collaborator

Study Sites (3)

Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Gabrail Cancer Center Research

Canton, Ohio, 44718, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Related Publications (1)

• El Haddaoui H, Brood R, Latifi D, Oostvogels AA, Klaver Y, Moskie M, Mustafa DA, Debets R, van Eijck CHJ. Rintatolimod (Ampligen(R)) Enhances Numbers of Peripheral B Cells and Is Associated with Longer Survival in Patients with Locally Advanced and Metastasized Pancreatic Cancer Pre-Treated with FOLFIRINOX: A Single-Center Named Patient Program. Cancers (Basel). 2022 Mar 8;14(6):1377. doi: 10.3390/cancers14061377.

  PMID: 35326528 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

poly(I).poly(c12,U)

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• David R Strayer, MD

  AIM ImmunoTech Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 10, 2022
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)