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Dose Escalation Trial of Bexmarilimab (FP-1305) Plus Pembrolizumab in Non-Small Cell Lung Cancer

EG
Overseen ByEpp Goodwin
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: The University of Texas Health Science Center at San Antonio
Must be taking: Pembrolizumab
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

SK

Supreet Kaur, MD

Principal Investigator

UT Health San Antonio

Eligibility Criteria

Inclusion Criteria

Women of child-bearing potential must have a negative pregnancy test prior to trial entry and cycle 1 day 1 and should not be breast feeding.
Able to provide written Informed Consent
Tumor sample obtained less than six months from the date of consent
See 5 more

Exclusion Criteria

Pregnant or lactating women
Any condition that study investigators consider an impediment to safe trial participation
Less than 21 days since the last dose of intravenous anticancer chemotherapy or less than five half-lives from a small molecule targeted therapy or oral anticancer chemotherapy before the first bexmarilimab administration
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation Treatment

Participants receive Bexmarilimab plus Pembrolizumab in a 3+3 dose escalation format to determine the maximum tolerated dose

12 weeks
Every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

  • Bexmarilimab (FP-1305)
  • Pembrolizumab
Participant Groups
4Treatment groups
Experimental Treatment
Group I: Cohort 4Experimental Treatment2 Interventions
Study participants will receive 30 mg/kg Bexmarilimab plus pembrolizumab 200mg IV once every 3 weeks.
Group II: Cohort 3Experimental Treatment2 Interventions
Study participants will receive 10 mg/kg Bexmarilimab plus pembrolizumab 200mg IV once every 3 weeks. 3 participants will need to complete this level before the next cohort dosing begins.
Group III: Cohort 2Experimental Treatment2 Interventions
Study participants will receive 3mg/kg Bexmarilimab given in combination with Pembrolizumab 200mg IV once every three weeks. 3 participants will need to complete this level before the next cohort dosing begins.
Group IV: Cohort 1Experimental Treatment2 Interventions
Study patients will receive 0.1-1 mg/kg bexmarilimab (FP-1350) given in combination with Pembrolizumab 200mg IV once every three weeks. The first subject will be started on 0.1mg to establish toleration, for one dose, and then the dose will be escalated to 1mg. This subject will be included in Cohort 1 data.

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials
486
Recruited
92,500+

Faron Pharmaceuticals Ltd

Industry Sponsor

Trials
9
Recruited
780+

Findings from Research

In a phase II trial involving 15 patients with resectable non-small cell lung cancer (NSCLC), neoadjuvant treatment with pembrolizumab showed a major pathologic response in 27% of patients, indicating promising antitumor activity before surgery.
The treatment was found to be feasible and safe, with only 33% of patients experiencing moderate adverse events, and no postoperative mortality, suggesting that pembrolizumab does not compromise surgical outcomes.
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience.Eichhorn, F., Klotz, LV., Kriegsmann, M., et al.[2022]
In a study of 655 patients with advanced melanoma, pembrolizumab showed a 5-year overall survival rate of 34%, with even better outcomes (41%) for treatment-naive patients, indicating its long-term efficacy.
The treatment was generally well-tolerated, with 86% of patients experiencing treatment-related adverse events, but only 7.8% discontinued due to these effects, suggesting a manageable safety profile.
Five-year survival outcomes for patients with advanced melanoma treated with pembrolizumab in KEYNOTE-001.Hamid, O., Robert, C., Daud, A., et al.[2023]
Pembrolizumab (KEYTRUDA) was approved by the FDA for treating advanced melanoma, showing an overall response rate of 24% in a trial of 89 patients, with 86% of responses lasting at least 6 months.
While there are potential immune-mediated side effects, the benefits of prolonged tumor response durations were deemed to outweigh these risks, marking an improvement over existing treatments.
FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma.Chuk, MK., Chang, JT., Theoret, MR., et al.[2021]

References

Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]
Five-year survival outcomes for patients with advanced melanoma treated with pembrolizumab in KEYNOTE-001. [2023]
FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. [2021]
Pembrolizumab: first global approval. [2021]
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]
Recurrent and atypical immune checkpoint inhibitor-induced pneumonitis. [2023]
Real-world experience with pembrolizumab toxicities in advanced melanoma patients: a single-center experience in the UK. [2022]
Programmed Cell Death-1 Inhibitor-Induced Type 1 Diabetes Mellitus. [2022]
[Prolonged response with paclitaxel after immunotherapy by pembrolizumab in lung cancer]. [2017]
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