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Monoclonal Antibodies

Pembrolizumab for Non-Small Cell Lung Cancer

Phase 1

Waitlist Available

Led By Supreet Kaur, MD

Research Sponsored by The University of Texas Health Science Center at San Antonio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to study end (approximately 12 months)

Awards & highlights

Study Summary

This trial is testing the effects of an investigational drug, Bexmarilimab, on patients with non-small cell lung cancer.

Eligible Conditions

Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to study end (approximately 12 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to study end (approximately 12 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to study end (approximately 12 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Programmed Death Cell Ligand 1 (PD-L1) level

Safety and tolerability

Secondary outcome measures

Immunophenotyping

Other outcome measures

Objective Response Rate (ORR)

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor

453 Previous Clinical Trials

91,430 Total Patients Enrolled

Faron Pharmaceuticals LtdIndustry Sponsor

8 Previous Clinical Trials

806 Total Patients Enrolled

Supreet Kaur, MDPrincipal InvestigatorUT Health San Antonio

1 Previous Clinical Trials

28 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the possible dangers of Pembrolizumab?

"Pembrolizumab's safety is only supported by limited data, as this is a Phase 1 trial, and thus it received a score of 1."

Answered by AI

What condition has Pembrolizumab been most successful in alleviating?

"Pembrolizumab is a medication that oncologists often prescribe to fight cancer. Additionally, it can be used to treat conditions like unresectable melanoma, microsatellite instability high, and chemotherapy-resistant disease progression."

Answered by AI

Are there other ongoing research projects utilizing Pembrolizumab?

"As of right now, there are 1001 trials ongoing that are researching pembrolizumab. 122 of those trials are in Phase 3. The majority of studies for pembrolizumab are based in Houston, Texas, but there are 35917 locations running trials for this treatment worldwide."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Dose Escalation Trial of Bexmarilimab (FP-1305) Plus Pembrolizumab in Non-Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05171062.