Bexmarilimab + Pembrolizumab for Lung Cancer

Overseen By Epp Goodwin

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: The University of Texas Health Science Center at San Antonio

Must be taking: Pembrolizumab

Must not be taking: Immunotherapy, Corticosteroids

Disqualifiers: CNS metastases, Serious infection, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with non-small cell lung cancer (NSCLC). Participants will receive a combination of two drugs: an experimental one called Bexmarilimab (FP-1305) and a standard one called Pembrolizumab. The researchers aim to determine if this combination can activate the immune system to help eliminate cancer. Individuals diagnosed with NSCLC and eligible for Pembrolizumab treatment might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

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.

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

Research shows that pembrolizumab, a drug used in this trial, is generally well-tolerated by patients. Safety data from earlier studies indicate no major safety concerns with pembrolizumab at the usual doses. The FDA has already approved pembrolizumab for other conditions, suggesting its safety.

Bexmarilimab, however, is still under safety investigation. As this trial is in the early stages, researchers are gathering information on patient responses. The aim is to find the safest dose that patients can handle without serious side effects. So far, no clear evidence links bexmarilimab to serious side effects. However, as with any new treatment, monitoring for possible side effects is crucial.

Overall, while pembrolizumab's safety is well-documented, bexmarilimab remains under investigation. Participants in the trial will be closely monitored to ensure their safety as researchers learn more about bexmarilimab's effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Bexmarilimab because it offers a fresh approach to treating non-small cell lung cancer. Unlike standard treatments that typically use chemotherapy or existing immunotherapies like pembrolizumab alone, Bexmarilimab targets a unique immune checkpoint receptor, CLEVER-1, which may help the immune system better recognize and attack cancer cells. By combining Bexmarilimab with pembrolizumab, the treatment aims to enhance the body's immune response more effectively than current options. This novel mechanism of action provides hope for improved outcomes in patients who may not respond well to existing therapies.

What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?

Research shows that using bexmarilimab with pembrolizumab may help treat certain cancers. In this trial, participants will receive different dosages of bexmarilimab combined with pembrolizumab. An earlier study found that bexmarilimab combined with another drug reduced cancer in 85% of patients. Studies like KEYNOTE-189 have shown that pembrolizumab alone helps lung cancer patients live longer. Together, these two drugs might enhance the immune system's ability to fight cancer cells. Although specific data for non-small cell lung cancer is not available, these findings suggest possible benefits for patients with this type of cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Supreet Kaur, MD

Principal Investigator

UT Health San Antonio

Are You a Good Fit for This Trial?

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Bexmarilimab (FP-1305)
• Pembrolizumab

How Is the Trial Designed?

Group I: Cohort 4 Experimental Treatment 2 Interventions

Study participants will receive 30 mg/kg Bexmarilimab plus pembrolizumab 200mg IV once every 3 weeks.

Group II: Cohort 3 Experimental Treatment 2 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 2 Experimental Treatment 2 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 1 Experimental Treatment 2 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.

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Pembrolizumab, a PD-1 inhibitor used in cancer treatment, can lead to rare but serious immune-related adverse events, including type 1 diabetes mellitus, occurring in about 0.2% of cases.

A review of 42 cases revealed that patients may develop diabetic ketoacidosis during treatment, highlighting the need for blood glucose monitoring and awareness of this potential side effect among clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Programmed Cell Death-1 Inhibitor-Induced Type 1 Diabetes Mellitus. Clotman, K., Janssens, K., Specenier, P., et al.[2022]

Pembrolizumab, a PD-1 inhibitor, has demonstrated clinical effectiveness in treating various solid tumors, particularly in patients with PD-L1-positive non-small-cell lung cancer and unresectable/metastatic melanoma.

Early-phase trials and ongoing studies are focused on further confirming the clinical benefits of pembrolizumab in thoracic malignancies, highlighting its potential as a significant treatment option in cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. Karim, S., Leighl, N.[2017]

Pembrolizumab, an immune checkpoint inhibitor, can cause pneumonitis in 1%-5% of patients, and this case report highlights an atypical presentation of this side effect in a patient with metastatic squamous cell carcinoma.

The patient was successfully treated with steroid therapy after ruling out other potential causes, leading to complete resolution of the pneumonitis, emphasizing the importance of recognizing and managing atypical cases of checkpoint inhibitor-pneumonitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recurrent and atypical immune checkpoint inhibitor-induced pneumonitis. Jeon, WJ., Nguyen, J., Castillo, DR., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. Chuk, MK., Chang, JT., Theoret, MR., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-year survival outcomes for patients with advanced melanoma treated with pembrolizumab in KEYNOTE-001. Hamid, O., Robert, C., Daud, A., et al.[2023]

In a study of 88 advanced melanoma patients treated with pembrolizumab, 81.8% experienced any-grade toxicities, with skin and gastrointestinal issues being the most common side effects.

Despite the high incidence of side effects, pembrolizumab was found to be well tolerated in real-world settings, and severe toxicities were manageable with systemic steroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world experience with pembrolizumab toxicities in advanced melanoma patients: a single-center experience in the UK. So, AC., Board, RE.[2022]

A 68-year-old patient with stage IV lung adenocarcinoma showed an unexpected positive response to paclitaxel after failing treatment with pembrolizumab, an anti-PD-1 immunotherapy.

The patient experienced a response duration of over fourteen months with paclitaxel, suggesting that combining or sequencing chemotherapy with immunotherapy may enhance treatment effectiveness in certain cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prolonged response with paclitaxel after immunotherapy by pembrolizumab in lung cancer]. Zapata, E., Mennecier, B., Leduc, C., et al.[2017]

Pembrolizumab (Keytruda) is the first anti-PD-1 therapy approved in the US for treating advanced malignant melanoma, specifically for patients who have progressed after prior treatments.

It is designed to target the PD-1 protein, enhancing the immune system's ability to fight cancer, and is currently under review for approval in the EU.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab: first global approval. Poole, RM.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05171062

Dose Escalation Trial of Bexmarilimab (FP-1305) Plus ... This study is an open label, Phase Ib, standard 3+3 dose escalation trial of bexmarilimab (FP-1305) plus pembrolizumab in 4 planned dose escalation cohorts in ...

2. faron.com faron.com/releases-and-publications/updated-bexmab-phase-i-ii-data-presented-at-esmo-2025-shows-further-improvement-strengthening-the-clinical-profile-of-bexmarilimab-in-treatment-naive-hr-mds-patients/

Updated BEXMAB Phase I/II Data presented at ESMO 2025 ... Bexmarilimab and azacitidine combination resulted in an 85% objective response rate (ORR; 17/20 evaluable patients) and a 45% complete remission ...

3. msdclinicaltrials.com msdclinicaltrials.com/trial/nct02861573/

Study of Pembrolizumab Combination Therapies in Metastatic ... The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combination therapy in participants with metastatic castration ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02853305

NCT02853305 | Study of Pembrolizumab With or Without ... The purpose of this study is to determine the efficacy and safety of pembrolizumab (pembro, MK-3475) with or without chemotherapy versus chemotherapy alone ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9618586/

Real-world outcomes at US oncology practices - PMC The efficacy of this combination regimen is supported by KEYNOTE-189 and -021 clinical trial results demonstrating superior overall survival (OS) for patients ...

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Safety Data Sheet OSHA: No component of this product present at a level equal to or greater than 0.1% is identified as a potential or confirmed carcinogen by OSHA ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05171062

Dose Escalation Trial of Bexmarilimab (FP-1305) Plus ... This study is an open label, Phase Ib, standard 3+3 dose escalation trial of bexmarilimab (FP-1305) plus pembrolizumab in 4 planned dose escalation cohorts in ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/125514s124lbl.pdf

KEYTRUDA (pembrolizumab) - accessdata.fda.gov Safety data are available for the first 203 patients who received KEYTRUDA and chemotherapy (n=101) or placebo and chemotherapy (n=102). Patients with ...

9. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-02481

FP-1305 (Bexmarilimab) plus Pembrolizumab for the ... Giving bexmarilimab in combination with pembrolizumab may have a synergistic (cooperative) effect that could kill more tumor cells in patients with NSCLC.

10. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2016/125514s012lbl.pdf

KEYTRUDA (pembrolizumab - accessdata.fda.gov Based on dose/exposure efficacy and safety relationships, there are no clinically significant differences in efficacy and safety between pembrolizumab doses of ...