RecruitingPhase 2NCT07207395

A Study of Orally Administered JBI-802 Alone or in Combination With Pembrolizumab for Patients With Non-small Cell Lung Cancer With an STK11 Mutation.

A Study of Open-label Orally Administered JBI-802 Alone or in Combination With Pembrolizumab in Patients With Advanced NSCLC Tumors Harboring an STK11 Mutation


Sponsor

The Christ Hospital

Enrollment

30 participants

Start Date

Apr 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to determine the overall safety and tolerability of JBI-802 as single agent and in combination with Pembrolizumab.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new oral drug called JBI-802, alone or combined with an immunotherapy drug (pembrolizumab), for people with advanced non-small cell lung cancer that carries a specific genetic change called an STK11 mutation. **You may be eligible if...** - You are 18 or older - You have been diagnosed with locally advanced or metastatic non-small cell lung cancer (NSCLC) with an STK11 gene mutation - Your blood counts and organ function (liver, kidneys) meet required levels - You have at least one measurable tumor on a scan - Your overall health is good enough to carry out daily activities (ECOG score 0–2) - You are able to swallow pills - You are willing to use contraception during and for at least 3 months after treatment **You may NOT be eligible if...** - You received cancer treatment or an investigational drug within the last 2 weeks - You had major surgery within the last 3 weeks - You have unstable brain metastases or are on steroids for brain swelling - You have serious heart problems (e.g., recent heart attack, severe arrhythmia, or significant heart failure) - You have a condition that affects how you absorb oral medications - You received a live vaccine in the last 30 days - You are taking strong medications that interact with certain liver enzymes (CYP3A or CYP2D6) 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

DRUGJBI-802

LSD1/HDAC6 Inhibitor

DRUGPembrolizumab

PD-1


Locations(1)

The Christ Hospital

Cincinnati, Ohio, United States

View Full Details on ClinicalTrials.gov

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

Visit

NCT07207395


Related Trials