RecruitingPhase 1NCT05234307

PBF-1129 and Nivolumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer

A Phase Ib Trial of PBF-1129 and Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer


Sponsor

Dwight Owen

Enrollment

30 participants

Start Date

Nov 21, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial studies the side effects and best dose of PBF-1129 in combination with nivolumab in treating patients with non-small cell lung cancer that has come back (recurrent) or spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as PBF-1129 and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a combination of two drugs — PBF-1129 (a new oral pill) and nivolumab (an immunotherapy) — for patients with advanced non-small cell lung cancer (NSCLC) that has come back or spread after prior treatment. **You may be eligible if...** - You are 18 or older with advanced or metastatic NSCLC that cannot be cured - You have already received standard chemotherapy and immunotherapy (including a PD-1/PD-L1 drug) - You are in generally good physical condition (able to carry out daily activities) - Your liver, kidneys, and blood counts are within acceptable ranges - You are able to swallow pills **You may NOT be eligible if...** - You have an active autoimmune disease requiring treatment - You have untreated or worsening brain metastases - You have had severe side effects (grade 3 or higher) from prior immunotherapy - You are pregnant or breastfeeding - You have HIV, active hepatitis B or C, or liver cirrhosis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAdenosine A2B Receptor Antagonist PBF-1129

Given PO

PROCEDUREBiospecimen Collection

Correlative studies

BIOLOGICALNivolumab

Given IV


Locations(1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05234307


Related Trials