Dose Escalation Trial of Bexmarilimab (FP-1305) Plus Pembrolizumab in Non-Small Cell Lung Cancer
Trial Summary
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you must not have had any immunotherapy in the three weeks before starting the trial, and you should not be on systemic corticosteroids or other immunosuppressive treatments.
What data supports the effectiveness of the drug pembrolizumab (KEYTRUDA) in treating cancer?
Pembrolizumab has shown effectiveness in treating advanced melanoma and non-small cell lung cancer by helping the immune system attack cancer cells. It has been approved for use in patients with melanoma who have not responded to other treatments, and studies have shown it can lead to prolonged tumor responses.12345
Is pembrolizumab generally safe for humans?
Pembrolizumab, also known as KEYTRUDA, has been studied in various clinical trials and is generally considered safe, but it can cause side effects. Common side effects include fatigue, cough, nausea, and rash, while more serious immune-related side effects like pneumonitis (lung inflammation) and colitis (inflammation of the colon) can occur in some patients.12367
What makes the drug combination of Bexmarilimab and Pembrolizumab unique?
The combination of Bexmarilimab and Pembrolizumab is unique because it involves using Pembrolizumab, a PD-1 inhibitor that helps the immune system attack cancer cells, which has shown effectiveness in various cancers. Bexmarilimab is a novel component that may enhance this effect, although specific details about its mechanism in this combination are not provided in the available research.15689
What is the purpose of this trial?
This trial tests a new drug, Bexmarilimab, combined with Pembrolizumab, in patients with non-small cell lung cancer. The goal is to see if this combination is safe and can help the immune system fight cancer by blocking a specific receptor. The study will increase the dose over time to find the highest safe amount.
Research Team
Supreet Kaur, MD
Principal Investigator
UT Health San Antonio
Eligibility Criteria
Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation Treatment
Participants receive Bexmarilimab plus Pembrolizumab in a 3+3 dose escalation format to determine the maximum tolerated dose
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Bexmarilimab (FP-1305)
- Pembrolizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center at San Antonio
Lead Sponsor
Faron Pharmaceuticals Ltd
Industry Sponsor