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

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Jeffrey Clarke, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation Treatment

Participants receive GT103 every 3 weeks with dose escalation from 0.3 mg/kg to 10 mg/kg or until the maximum tolerated dose (MTD) is found

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+