Actively Recruiting
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.
Led by The Christ Hospital · Updated on 2025-10-06
30
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to determine the overall safety and tolerability of JBI-802 as single agent and in combination with Pembrolizumab.
CONDITIONS
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 years or older at Screening
- Histologically confirmed locally advanced or metastatic NSCLC with an STK11 mutation
- Absolute neutrophil count at least 1500 cells/mm3
- Platelet count at least 100,000 cells/mm3
- Total bilirubin less than or equal to 1.5 times upper limit of normal (ULN), up to 3.0x ULN for Gilbert's syndrome
- AST and ALT less than or equal to 2.5 times ULN (up to 5 times ULN if liver metastases present)
- Calculated creatinine clearance at least 40 mL/min
- Prothrombin time or activated partial thromboplastin time less than or equal to 1.5 times ULN if not anticoagulated
- Stable dose of anticoagulants for at least 2 weeks prior to study entry if applicable
- At least one measurable lesion on CT or MRI per RECIST 1.1
- Resolution of prior therapy toxic effects to Grade 0 or 1 except alopecia and some chronic Grade 2 conditions
- ECOG performance status of 0 to 2
- Able to swallow oral medication
- Willing and able to give informed consent and follow study requirements
- Willingness to use effective contraception during treatment and for 3 months after last dose
You will not qualify if you...
- Treatment with systemic anticancer therapy or investigational agents within 2 weeks or 5 half-lives before study drug
- Major surgery within 21 days before starting study drug or not recovered from surgery effects
- Surgery or medical conditions affecting medication absorption
- Radiotherapy within 2 weeks prior to study drug (7 days for certain types) and not recovered from related toxicities
- Active malignant central nervous system disease except stable treated brain metastases
- Severe or unstable medical conditions including serious heart conditions
- Congenital long QT syndrome or corrected QT interval above 480 msec
- History of other cancers interfering with safety or efficacy assessment
- Live vaccines within 30 days before first dose of JBI-802
- Use of glucocorticoids except certain allowed uses
- Use of strong CYP3A or CYP2D6 inhibitors or inducers within specified times before study start
- Major active infections requiring intravenous antibiotics
- Active HIV or hepatitis B or C infection
- Active gastrointestinal diseases affecting absorption
- Acute illness within 14 days before dosing unless mild and approved
- Active infection requiring antibiotics
- Pregnancy, breastfeeding, or planning to conceive during the trial
- Current participation in other clinical trials of investigational agents without approval
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
Research Team
A
Abby Reed
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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