GT103 for Non-Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, GT103, to determine the safest dose and assess its effectiveness for people with advanced non-small cell lung cancer (NSCLC) that has worsened despite previous treatments. Participants will receive GT103 every three weeks, with gradually increasing dosages to identify the most effective tolerable amount. Individuals with advanced NSCLC who have tried treatments like immunotherapy and chemotherapy, yet their cancer continues to grow, might be suitable for this trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding how GT103 works in people.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop taking any anticancer therapies at least 2 weeks before starting the study drug. If you are on chronic systemic corticosteroids or other immunosuppressive agents, you may need to adjust your treatment, but some exceptions apply, such as low-dose intermittent steroids or physiologic replacement doses.
Is there any evidence suggesting that GT103 is likely to be safe for humans?
Research has shown that GT103 has been safe in earlier studies with patients who have non-small cell lung cancer. In one study, most participants handled the treatment well, experiencing only mild side effects that were usually easy to manage. Another study found that GT103 remained safe when combined with another cancer drug, suggesting new treatment options. Although this trial is just starting, past research provides hope regarding the safety of GT103.12345
Why do researchers think this study treatment might be promising?
GT103 is unique because it targets non-small cell lung cancer in a novel way. Unlike traditional treatments like chemotherapy and targeted therapies that often attack cancer cells directly or inhibit specific growth factors, GT103 works by escalating its dose to find the maximum tolerated dose. This escalation approach might help in fine-tuning the treatment to maximize effectiveness while minimizing side effects. Researchers are excited about GT103 as it may offer a new pathway for treating lung cancer, potentially improving outcomes for patients who haven't responded to existing therapies.
What evidence suggests that GT103 might be an effective treatment for non-small cell lung cancer?
Research has shown that GT103 may help treat non-small cell lung cancer (NSCLC). GT103 is a special type of medicine that aids the immune system in attacking cancer cells by targeting a protein called complement factor H. In earlier studies, GT103 was combined with pembrolizumab, and some patients experienced lasting health improvements. The treatment proved safe and did not cause any unexpected issues. These findings suggest GT103 could be a useful option for people with NSCLC. Participants in this trial will receive GT103 every three weeks, with doses increased until the maximum tolerated dose is determined.12367
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- GT103
Find a Clinic Near You
Who Is Running the Clinical Trial?
Edward Patz
Lead Sponsor