NCI-2023-00135

A Phase I/IIa, Open-label, Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Anti-tumor Activity of H002 in Patients with Active Epidermal Growth Factor Receptor Mutation Locally Advanced or Metastatic Non-small Cell Lung Cancer

This Phase I/IIa study involves testing a drug named H002 in patients diagnosed with locally advanced or metastatic non-small cell lung cancer (NSCLC) that carries a specific genetic mutation called epidermal growth factor receptor (EGFR) mutation. The study is divided into two parts: dose escalation and expansion. Researchers will gradually increase the dose of H002 to find the safest and most effective dose, and then expand the study to evaluate its effectiveness in a larger group of patients. The main objectives are to assess the safety, tolerability, how the body processes the drug (pharmacokinetics), and its initial effectiveness in treating NSCLC.

Phase I/IIa study: A study that assesses the safety, effectiveness, and how well the treatment works

non-small cell lung cancer: A type of lung cancer with non small cells that grow too much and can spread to other parts of the body

metastatic: cancer that has spread from its original location or organ to other parts of the body.

epidermal growth factor receptor (EGFR) mutation: Epidermal Growth Factor Receptor (EGFR) is on the surface of cells and helps them grow and divide. In cancer, EGFR is like a switch that gets stuck in the "on" position, making cells grow and divide too much.

pharmacokinetics: Pharmacokinetics studies how medicines move around in the body, including how they are absorbed, distributed, broken down, and removed.

For more information about the trial, click the link below:

https://clinicaltrials.gov/ct2/show/NCT05519293

Clinical Trial Site: Columbia

To see all available clinical trials click here.