GT103 for Non-Small Cell Lung Cancer

Recruiting at 2 trial locations

Overseen By DCI Multi-Site Studies

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Edward Patz

Must be taking: Immunotherapy, Platinum chemotherapy

Must not be taking: Corticosteroids, Immunosuppressants

Disqualifiers: Brain metastases, Autoimmune diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

31 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to determine the maximum tolerated dose of GT103 and investigate the safety and effectiveness of the study drug.

Research Team

Jeffrey Clarke, MD

Principal Investigator

Duke University

Eligibility Criteria

Adults over 18 with advanced stage III, IV or recurrent NSCLC that's worsened after prior therapy can join. They must have measurable disease, acceptable organ function, and no severe allergies to PD-1/PD-L1 drugs. Participants need a stable ECOG status (0 or 1), adequate bone marrow function, and must use effective contraception.

Inclusion Criteria

My advanced lung cancer has worsened after previous treatment.

Signed informed consent

My liver is functioning within the required limits.

Exclusion Criteria

I haven't had major surgery or significant injury in the last 4 weeks and don't expect to need major surgery during the study.

I need medication for brain-related cancer symptoms.

I am not pregnant, breastfeeding, and if capable of having children, I am using effective birth control.

Treatment Details

Interventions

• GT103

Trial Overview The trial is testing GT103's highest dose patients can tolerate while checking its safety and effectiveness against advanced non-small cell lung cancer. It involves people whose cancer has progressed despite previous treatments.

Participant Groups

Group I: GT103 Experimental Treatment 1 Intervention

Participants will receive GT103 every 3 weeks. GT103 will be escalated from .3mg/kg up 10 to mg/kg or until MTD is found

Who Is Running the Clinical Trial?

Edward Patz

Lead Sponsor

Trials

1

Recruited

30+