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.

{ "JBI-802 Alone or With Pembrolizumab for STK11-Mutated Lung Cancer", "This study is testing JBI-802, a drug that targets specific proteins (LSD1/HDAC6 Inhibitor), by itself and in combination with pembrolizumab (a type of immunotherapy called PD-1 inhibitor). It's for people with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have a specific genetic change called an STK11 mutation. The main goals are to see how safe the treatments are and how well they shrink tumors. You must be at least 18 years old and have certain blood test results to join. The study is currently unclear on its recruitment status.", "design": "This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It aims to enroll 30 participants.", "commitments": "You would take JBI-802 by mouth once daily, 4 days on and 3 days off. If you are in the combination group, you would also receive pembrolizumab every 3 weeks.", "compensation": "Not stated in the trial record.", "follow_up": "Your safety will be monitored for up to 28 days after your last dose of study drug, and tumor response will also be assessed during this time.", }

Study design: Not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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.

Recruiting

PHASE2Ages 18+InterventionalTreatment

The Christ Hospital

~30 participants

Updated 2025-10-06 on ClinicalTrials.gov

What's tested:JBI-802Pembrolizumab

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Incidence of Adverse Events

Measured over Up to 28 days after last dose of study drug

+1 more outcome measured

Conditions

Lung Cancer (NSCLC)

Where it's being run

1 sites across 1 states

Ohio1

Who to contact

Abby Reed

[email protected]

513-585-0844

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Absolute neutrophil count (ANC) ≥1500 cells/mm3.

Platelet count ≥100,000 cells/mm3.

Total bilirubin ≤1.5×ULN. Patients with Gilbert's syndrome may be enrolled with up to 3.0xULN.

AST and ALT ≤2.5×ULN (unless liver metastases are present then up to 5×ULN is allowed).

Calculated creatinine clearance (CrCL) ≥40 mL/min calculated per Institutional standard.

Prothrombin time (PT) or activated partial thromboplastin time (aPTT)

1.5×ULN if participant is not anticoagulated (Note: If participant is on anticoagulants, the participant must be on a stable dose for at least 2 weeks prior to study entry. 4. Must have at least one measurable lesion on CT scan or MRI per RECIST 1.1 5. Resolution of any clinically significant toxic effects of prior therapy to Grade 0 or 1 according to the NCI CTCAE, Version 5.0 (exception of alopecia and Grade 2 peripheral neuropathy, chronic Grade 2 endocrinopathies as a result of prior immunotherapy). 6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2. 7. Able to swallow oral medication. 8. Willing and able to give informed consent and comply with protocol requirements for the duration of the study. 9. Willingness to use contraception by a method that is deemed effective by the Investigator by both males and female participants of childbearing potential (post-menopausal women must have been amenorrheal for at least 12 months to be considered of non-childbearing potential) and their partners throughout the treatment period and for at least 3 months following the last dose of study drug.

What this trial measures

Incidence of Adverse EventsUp to 28 days after last dose of study drug
Characterized overall and by type, seriousness, relationship to study treatment, timing, and severity graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Investigator Assessed ORRUp to 28 days from last dose of study drug
Investigator-assessed overall response rate (ORR) indicated by stable disease, partial response or complete response and progression free survival (PFS) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Trialytics