GT103 + Pembrolizumab for Non-Small Cell Lung Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Roswell Park Cancer Institute

Must be taking: Pembrolizumab

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Brain metastasis, Autoimmune disorder, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 51

Duration: Up to 2 years

28 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment combination for individuals with advanced or metastatic non-small cell lung cancer, specifically those with an STK11 gene mutation. The researchers aim to evaluate the effectiveness of the monoclonal antibody GT103 in combination with pembrolizumab, an immunotherapy drug that aids the immune system in fighting cancer. This trial may suit those with non-small cell lung cancer and the STK11 mutation who have previously received pembrolizumab but require additional options. As a Phase 2 trial, it focuses on assessing the treatment's effectiveness in an initial, smaller group, providing access to potentially effective new therapies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot have received anticancer chemotherapy within 4 weeks before starting the study drug, and you should not be on systemic corticosteroids unless they are for hormone replacement or short-term use.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using GT103 with pembrolizumab is safe for patients. Studies have found that this combination is generally well tolerated, with no new safety issues reported. Some patients experienced lasting benefits without serious side effects. This suggests that the treatment could be a safe option for those with advanced non-small cell lung cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about GT103 combined with pembrolizumab for non-small cell lung cancer because it offers a novel approach to treatment. Unlike traditional therapies that might focus solely on broad immune activation or direct cancer cell targeting, GT103 is designed to enhance the immune system's ability to recognize and attack cancer cells more effectively. Additionally, when paired with pembrolizumab, an established checkpoint inhibitor, this combination has the potential to improve the immune response against the tumor. This dual approach could lead to better outcomes for patients by potentially overcoming resistance seen in current treatments.

What evidence suggests that GT103 and pembrolizumab could be effective for non-small cell lung cancer?

Research has shown that combining GT103 with pembrolizumab may help treat non-small cell lung cancer in patients with the STK11 mutation. This trial will evaluate the safety and effectiveness of this combination. Studies have found that this combination is safe and can be effective for some patients, leading to lasting improvements and control of the disease. GT103 targets a protein called complement factor H, which may help prevent cancer cells from growing and spreading. Pembrolizumab, a type of immunotherapy, helps the body's immune system attack cancer cells. Together, these treatments might improve the chances of destroying cancer cells and lead to better outcomes for patients. ^{1 2 3 6 7}

Who Is on the Research Team?

Edwin H Yau

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

This trial is for people with advanced or metastatic non-small cell lung cancer that has a specific mutation (STK11). Participants should have cancer that's spread from its original site. They must meet certain health standards, which will be determined through tests like biopsies and imaging.

Inclusion Criteria

ANC ≥ 1.5 x 10^9/L

Estimated glomerular filtration rate (GFR) > 45mL/min

Participants of child-bearing potential must agree to use adequate contraceptive methods

Exclusion Criteria

I haven't had radiotherapy or gamma knife for non-brain cancer within 2 weeks.

Pregnant or nursing female participants

I have no health issues preventing me from taking the study drug.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive GT103 and pembrolizumab intravenously on day 1 of each cycle, with cycles repeating every 21 days for up to 2 years

Up to 2 years

Every 21 days

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

120 days

Every 30 days

What Are the Treatments Tested in This Trial?

Interventions

• GT103
• Pembrolizumab

Trial Overview The trial is testing GT103 combined with pembrolizumab to see if it can better treat this type of lung cancer. GT103 targets proteins on cancer cells, potentially stopping their growth, while pembrolizumab boosts the immune system's response against the cancer.

How Is the Trial Designed?

Group I: Treatment (GT103, pembrolizumab) Experimental Treatment 7 Interventions

Patients receive GT103 IV over 60 minutes and pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO at baseline, MRI at baseline and as clinically indicated, and CT and blood sample collection throughout the study. Patients may also undergo biopsy throughout the study.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Citations

1. jitc.bmj.com jitc.bmj.com/content/12/Suppl_3/A1717

1487 Results from a phase II study of GT103 in ... A phase I trial of GT103 monotherapy has demonstrated the therapy to be well tolerated in advanced NSCLC patients. Preclinical data suggests ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41129008/

A Phase II study of GT103 in combination with ... Combination of GT103 with pembrolizumab was well tolerated with no new safety signals. A subset of patients experienced durable responses and disease ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07017829

Study Details | NCT07017829 | GT103 in Combination With ... This phase II trial tests how well GT103 in combination with pembrolizumab works in treating patients with STK11 mutant non-small cell lung cancer that may ...

4. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/10.1002/cncr.70141?af=R

A Phase II study of GT103 in combination with pembrolizumab ... Combining GT103, a fully human immunoglobulin G3 monoclonal antibody targeting complement factor H, with pembrolizumab is safe and ...

5. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-01818

GT103 and Pembrolizumab for the Treatment of Patients ... Giving GT103 with pembrolizumab may kill more cancer cells and improve outcomes in patients with recurrent or refractory metastatic non-small cell lung cancer.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05617313

NCT05617313 | Study of GT103 in Combination With ... This open-label, non-randomized Phase II trial is designed to assess the safety and tolerability of GT103 in combination with pembrolizumab in adult ...

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-08947

GT103 in Combination with Pembrolizumab for the ... This phase II trial tests how well GT103 in combination with pembrolizumab works in treating patients with STK11 mutant non-small cell lung cancer that may ...