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.

NCT07207395 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2024-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer (NSCLC)

Keywords

STK11 Mutation; NSCLC; Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Incidence of Adverse Events

  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

  Up to 28 days after last dose of study drug

• Investigator Assessed ORR

  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.

  Up to 28 days from last dose of study drug

Study Arms (2)

Monotherapy

EXPERIMENTAL

JBI-082 Single Agent

Drug: JBI-802

Combination

EXPERIMENTAL

JBI-802 plus Pembrolizumab

Drug: JBI-802; Drug: Pembrolizumab

Interventions

JBI-802 DRUG

LSD1/HDAC6 Inhibitor

Combination; Monotherapy

Pembrolizumab DRUG

PD-1

Combination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females aged ≥18 years at Screening.
• Participants with a histologically confirmed diagnosis of locally advanced or metastatic NSCLC harboring an STK11 mutation.
• Screening laboratory values:
• 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)
• ×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.
• Must have at least one measurable lesion on CT scan or MRI per RECIST 1.1
• 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).
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
• Able to swallow oral medication.
• Willing and able to give informed consent and comply with protocol requirements for the duration of the study.

You may not qualify if:

• Treatment with systemic anticancer therapy or an investigational agent within 2 weeks or 5 half-lives, whichever is shorter, prior to start of study drug treatment.
• Major surgery ≤21 days prior to starting study drug or has not recovered from adverse effects of such procedure.
• Surgery (eg, stomach bypass) or medical condition that might significantly affect absorption of medicines (as judged by the Investigator).
• Radiotherapy within 2 weeks prior to start of study drug treatment (palliative radiation or stereotactic radiosurgery within 7 days prior to start of study treatment). Participants must have recovered from all radiotherapy-related toxicities.
• Known malignant central nervous system disease other than neurologically stable, treated brain metastases- defined as metastasis having no evidence of progression or hemorrhage for at least 4 weeks after treatment (including brain radiotherapy). Must be off any systemic corticosteroids for the treatment of symptomatic brain metastases for at least 14 days prior to enrollment.
• Severe or unstable medical condition, such as congestive heart failure (New York Heart Association \[NYHA\] Class III or IV), ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, psychiatric condition, as well as an uncontrolled cardiac arrhythmia requiring medication (≥Grade 2, according to NCI CTCAE Version 5), myocardial infarction within 6 months prior to starting study treatment, or any other significant or unstable concurrent cardiac illness. Note: Stable chronic atrial fibrillation is allowed.
• Congenital long QT syndrome or corrected QT interval by Fridericia (QTcF) interval \>480 msec for males and females, respectively, at Screening.
• History of other previous or concurrent cancer that would interfere with the determination of safety or efficacy assessment with respect to the qualifying solid tumor malignancy.
• Live vaccines within 30 days prior to the first dose of JBI-802.
• Glucocorticoids for any purpose other than to modulate symptoms from an event of clinical interest) or for use as a premedication in participants with a known history of an IV contrast allergy administered as part of CT radiography. Inhaled, intranasal, intraocular, topical, and intraarticular joint injections of steroids are permitted.
• Use of strong inhibitors of cytochrome P450 3A (CYP3A) within 14 days or 5 half-lives (whichever is longer) or grapefruit juice or grapefruit containing products within 7 days prior to Cycle 1 Day 1.
• Use of strong inducers of CYP3A within 14 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.
• Use of strong inhibitors of cytochrome CYP2D6 within 14 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.
• Use of strong inducers of CYP2D6 within 14 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.
• Major active infection requiring parenteral antibiotics.

Sponsors & Collaborators

• The Christ Hospital: lead

Study Sites (1)

The Christ Hospital

Cincinnati, Ohio, 45219, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Central Study Contacts

Abby Reed

CONTACT

513-585-0844; abby.reed@thechristhospital.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: October 6, 2025
• Study Start: April 29, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: October 6, 2025

Record last verified: 2025-10

Locations

US (1)