Nebulized AER101 in Pre-op NSCLC

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
University of Oklahoma
Study ID
NCT07631299
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Non-small Cell Lung Cancer Stage I
  • Non-small Cell Lung Cancer Stage II

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • AER101 — DRUG
    Nebulization of AER101

Study Details

The primary objective of this pilot study is to determine if AER101 can decrease glycolysis in non-small cell lung cancer (NSCLC). Glycolysis is the process cells use to break down sugar (glucose) into a smaller substance in the fluid part inside the cell. Many lung cancers begin in bronchi, bronchioles and alveoli cells surrounding the airways, which enables nebulization to deposit AER101 on lung tumors. Participants in the study will self-administer AER101 via a hand-held personal nebulizer three times per day (dosing at least 4 hours apart) for 14 days prior to undergoing surgery for lung cancer.

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
5 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nebulized AER 101
    Nebulized AER101, self-administered 3 times per day at 5 mL per treatment for 14 days

Primary Outcome Measure

PET SUVmax [ Time Frame: 14 days ]

Central Contacts

Locations (2)

FacilityCityStateZIP
OU Medical Center HospitalOklahoma CityOklahoma73106
Stephenson Cancer CenterOklahoma CityOklahoma73106

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OU Medical Center Hospital· Oklahoma City, OKStephenson Cancer Center· Oklahoma City, OK

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