AER101 for NSCLC

(AER101 Trial)

Not yet recruiting at 1 trial location
TJ
MR
Overseen ByMatthew R Reinersman, MD
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: University of Oklahoma
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new treatment, AER101, can reduce glycolysis (the process by which cells break down sugar) in individuals with non-small cell lung cancer (NSCLC). Participants will use a nebulizer, a device that turns medicine into a mist for inhalation, to self-administer AER101 three times daily for 14 days before their lung cancer surgery. The trial seeks individuals recently diagnosed with lung adenocarcinoma or squamous cell carcinoma who are planning surgery. As an Early Phase 1 trial, this research focuses on understanding how AER101 functions in people, offering participants the opportunity to be among the first to receive this new treatment.

Is there any evidence suggesting that AER101 is likely to be safe for humans?

A previous study tested AER101 for safety in patients with non-small cell lung cancer (NSCLC). However, detailed safety results are not yet available. Since this trial is in an early stage, the primary goal is to understand how the treatment works rather than thoroughly test its safety.

Early-phase trials mark the first time a treatment is tried in humans, so information on how well people tolerate it is limited. Participants will use a nebulizer to inhale AER101, which aims to target lung tumors directly. This method may help reduce side effects compared to treatments that affect the whole body.

If AER101 resembles other treatments studied in similar contexts, mild side effects may occur, but more information is needed to fully understand its safety. Researchers will closely monitor participants to quickly address any possible side effects.12345

Why do researchers think this study treatment might be promising for NSCLC?

Unlike the standard treatments for non-small cell lung cancer (NSCLC), which often involve systemic chemotherapy or targeted therapies, AER101 is administered directly to the lungs through a nebulizer. This delivery method allows for higher concentrations of the drug to reach the lung tissue directly, potentially improving its effectiveness while reducing systemic side effects. Researchers are excited about AER101 because it represents a more targeted approach, potentially offering quicker symptom relief and better tolerability for patients.

What evidence suggests that AER101 might be an effective treatment for NSCLC?

Research has shown that AER101 is designed to reduce the way cells use sugar for energy, a process called glycolysis. This is important because many lung cancers, such as non-small cell lung cancer (NSCLC), rely on this process to grow. By stopping glycolysis, AER101 might slow or halt tumor growth. In this trial, participants will receive AER101 delivered directly to the lungs with a nebulizer, which early results suggest could effectively target lung tumors. Although direct human data on AER101 is limited, the approach is based on strong scientific principles related to how cancer cells obtain energy.45678

Who Is on the Research Team?

MR

Matthew Reinersman, MD

Principal Investigator

University of Oklahoma

Are You a Good Fit for This Trial?

This trial is for people diagnosed with non-small cell lung cancer (NSCLC) who are scheduled to have surgery. Participants must be able to use a nebulizer and follow the dosing schedule before their operation.

Inclusion Criteria

I am eligible for surgery or radiation treatment.
I was recently diagnosed with lung adenocarcinoma or squamous cell carcinoma.
I have not yet had surgery to remove my primary tumor.
See 3 more

Exclusion Criteria

My tumor has come back after previous treatment.
My cancer has spread to lymph nodes or other parts of my body.
I am not able to give informed consent for my treatment.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants self-administer AER101 via a nebulizer three times per day for 14 days

2 weeks
Daily self-administration, final visit in-person for PET/CT scan

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • AER101

Trial Overview

The study tests if inhaling AER101 through a nebulizer three times daily for 14 days before lung cancer surgery can reduce how much sugar tumor cells use. All participants receive AER101 in this pilot study.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Nebulized AER 101Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials
484
Recruited
95,900+

Citations

Treatment Options for Advanced Non-Small Cell Lung ...

We conducted analyses of the outcomes, costs, and cost-effectiveness of treatment for advanced. NSCLC for two distinct populations: 1. First-line treatment ...

Non-small cell lung cancer: current treatment and future ... - PMC

Of the 55 patients evaluated, it was found that patients who received SBRT had a survival rate of 55.8% at three years along with moderate treatment-related ...

Nebulized AER101 in Pre-op NSCLC - ClinicalTrials.Veeva

The primary objective of this pilot study is to determine if AER101 can decrease glycolysis in non-small cell lung cancer (NSCLC).

Drug Combo Demonstrates Efficacy, Safety in Resectable ...

Nearly all the included patients started neoadjuvant treatment, with 72.1%–76.1% completing four treatment cycles across the three reported ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38827178/

First-line treatments for advanced non-squamous ...

In terms of efficacy, PembroC was most likely to be ranked first for extending progression-free survival (PFS) (93.16%) and overall survival (OS) ...

NCT07631299 | Nebulized AER101 in Pre-op NSCLC

The primary objective of this pilot study is to determine if AER101 can decrease glycolysis in non-small cell lung cancer (NSCLC). Glycolysis is ...

Safety outcomes in advanced non-small-cell lung cancer ...

We analyzed the treatment patterns and safety outcomes of the most common first-line platinum-based regimens initiated on or after non-small cell lung cancer ( ...

CASE STUDY IN NON-SMALL CELL LUNG CANCER

Data from the control arm may be compromised by early discontinuation or “cross-over” to the investigational therapy made available by AA,