Your session is about to expire
← Back to Search
Checkpoint Inhibitor
PBF-1129 + Nivolumab for Lung Cancer
Phase 1
Recruiting
Led By Dwight H Owen
Research Sponsored by Dwight Owen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= 18 years
Confirmed recurrent or metastatic non-small cell carcinoma of the lung of any histology without curative options
Must not have
Has active autoimmune disease, including myasthenic syndrome, which has required systemic treatment in the past 2 years
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (at a dose > 10 mg prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days after the last dose of study treatment
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group
Summary
This trial is testing PBF-1129 and nivolumab in patients with advanced lung cancer. The goal is to see if these drugs can work together to stop cancer growth and boost the immune system's ability to fight the cancer. Nivolumab has shown effectiveness in treating various cancers, including non-small cell lung cancer.
Who is the study for?
Adults with recurrent or metastatic non-small cell lung cancer who have tried standard treatments, including chemotherapy and immunotherapy. They must have good organ function, no untreated brain metastases, no active infections like HIV/Hepatitis B or C, not be pregnant/breastfeeding, and willing to use contraception. Prior PD-1/PD-L1 therapy is required; prior CTLA4 therapy is okay.
What is being tested?
The trial tests PBF-1129 combined with nivolumab to determine the safest dose and side effects for treating non-small cell lung cancer that has returned or spread. It explores how these drugs might help the immune system fight cancer by inhibiting tumor growth.
What are the potential side effects?
Potential side effects include reactions related to the immune system attacking normal organs (autoimmune reactions), infusion-related reactions from receiving drugs through a vein, fatigue, possible liver enzyme changes indicating liver damage, and increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have advanced lung cancer that has come back or spread, and there are no options to cure it.
Select...
If you have a specific gene mutation that can be treated with FDA-approved medications, you must have already tried all the standard treatments for that mutation. For example, if you have an EGFR mutation, you should have already tried osimertinib.
Select...
You are able to perform everyday activities without any problem or with a little restriction.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
You have a condition where your immune system attacks your own body and have needed strong treatment for it in the past 2 years.
Select...
You have a weakened immune system or are taking certain medications that weaken your immune system.
Select...
You have a current, ongoing infection with HIV, Hepatitis B, or Hepatitis C.
Select...
You have severe liver cirrhosis or serious complications from cirrhosis such as hepatic encephalopathy or significant fluid buildup in the abdomen.
Select...
You had bad side effects from a previous treatment with a checkpoint inhibitor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days after the last dose of study treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days after the last dose of study treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events
Secondary study objectives
Disease control rate
Overall objective response rate
Overall survival
+1 moreOther study objectives
Correlative biomarkers
Levels of myeloidderived suppressor cells (MDSC)
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (PBF-1129, nivolumab)Experimental Treatment3 Interventions
Patients receive PBF-1129 PO QD and nivolumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2030
Nivolumab
FDA approved
Find a Location
Who is running the clinical trial?
Dwight OwenLead Sponsor
5 Previous Clinical Trials
183 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,954 Previous Clinical Trials
41,111,653 Total Patients Enrolled
Dwight H OwenPrincipal InvestigatorOhio State University Comprehensive Cancer Center
3 Previous Clinical Trials
714 Total Patients Enrolled
Dwight H Owen, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
2 Previous Clinical Trials
42 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have brain metastases that have not been treated yet. If you have already been treated for brain metastases and are doing well, you may still be eligible.You have a recent tumor tissue sample stored in a special way, or you can provide unstained slides with tissue samples from a recent tumor biopsy or surgery.Your albumin levels are at least 2.5 mg/dL.Your blood clotting time is not too fast or too slow, unless you are taking medication to control it.You had bad side effects from a previous treatment with a checkpoint inhibitor.If you have a specific gene mutation that can be treated with FDA-approved medications, you must have already tried all the standard treatments for that mutation. For example, if you have an EGFR mutation, you should have already tried osimertinib.Your bilirubin levels in the blood should be within a certain range.You have advanced lung cancer that has come back or spread, and there are no options to cure it.You have a current, ongoing infection with HIV, Hepatitis B, or Hepatitis C.Your platelet count is at least 100,000 per microliter.You have a weakened immune system or are taking certain medications that weaken your immune system.You have a disease that can be measured using specific guidelines.Your heart's electrical activity shows signs of potential problems, such as a very long QT interval or any important abnormalities in your resting ECG.You are able to perform everyday activities without any problem or with a little restriction.You have enough infection-fighting white blood cells in your body.You have a condition where your immune system attacks your own body and have needed strong treatment for it in the past 2 years.You have already tried standard chemotherapy and immunotherapy. You may have had up to 3 previous treatments for your condition.You have severe liver cirrhosis or serious complications from cirrhosis such as hepatic encephalopathy or significant fluid buildup in the abdomen.You agree to give blood samples for additional research.Your kidney function is within a certain range, and your creatinine levels are not too high.Your liver enzymes (AST and ALT) should not be more than 2.5 times the upper limit of normal. If you have liver spread, they should not be more than 5 times the upper limit of normal.If you are a woman who could become pregnant, you must have a negative pregnancy test within a week before starting the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (PBF-1129, nivolumab)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.