Study on Oral JBI-802 Alone or with Pembrolizumab for Non-Small Cell Lung Cancer with STK11 Mutation

Sponsor: The Christ Hospital

Sponsor score: 0

ClinicalTrials ID:NCT07207395

Provider View

This clinical trial is testing the safety and tolerability of a new drug, JBI-802, taken alone or with Pembrolizumab, for patients with non-small cell lung cancer that has an STK11 mutation.

Patient Parameters

Program Overview

The purpose of this study is to find out if the new drug JBI-802, taken by mouth, is safe and well-tolerated when used alone or in combination with Pembrolizumab in patients with non-small cell lung cancer (NSCLC) that has a specific genetic mutation called STK11. Participants will take JBI-802 in a cycle of 4 days on and 3 days off, and Pembrolizumab will be given every 3 weeks.

Description

This study is being conducted at a single location and is open-label, meaning both the researchers and participants know what treatment is being given. The study aims to understand the safety and effectiveness of JBI-802, both on its own and when combined with Pembrolizumab, in treating non-small cell lung cancer with an STK11 mutation. Participants will take JBI-802 orally at a dose of 10 mg once daily for 4 days, followed by a 3-day break. Pembrolizumab will be administered at a dose of 200 mg every 3 weeks. The study will monitor how well the treatment works and how long any positive effects last.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years or older.
  • Diagnosed with locally advanced or metastatic non-small cell lung cancer (NSCLC) with an STK11 mutation.
  • Meet specific blood test requirements, including:
    • Neutrophil count of at least 1500 cells/mm³.
    • Platelet count of at least 100,000 cells/mm³.
    • Total bilirubin within 1.5 times the normal limit (up to 3 times for Gilbert's syndrome).
    • AST and ALT within 2.5 times the normal limit (up to 5 times if liver metastases are present).
    • Creatinine clearance of at least 40 mL/min.
  • Have at least one measurable tumor on a CT scan or MRI.
  • Any side effects from previous treatments must be mild or resolved.
  • ECOG performance status of 0 to 2, indicating full activity or some restriction in strenuous activities.
  • Able to swallow pills.
  • Willing to provide informed consent and follow study requirements.
  • Agree to use effective contraception during the study and for 3 months after the last dose.

Exclusion Criteria

  • Recent treatment with other cancer therapies or investigational drugs.
  • Major surgery within 21 days before starting the study.
  • Medical conditions affecting drug absorption.
  • Recent radiotherapy or unresolved side effects from it.
  • Active brain cancer, unless stable and treated.
  • Severe or unstable medical conditions, such as heart failure or uncontrolled diabetes.
  • Long QT syndrome or abnormal heart rhythm.
  • Other cancers that could interfere with the study.
  • Recent live vaccines.
  • Use of certain medications that affect drug metabolism.
  • Active infections requiring antibiotics.
  • HIV or active hepatitis B or C infections.
  • Digestive diseases affecting drug absorption.
  • Recent acute illness unless mild.
  • Pregnant or breastfeeding women, or those planning to conceive.
  • Participation in another clinical trial.

Locations

FACILITYZIPCITYSTATE
The Christ Hospital45219CincinnatiOhio

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