Lung Cancer (NSCLC)Phase 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 Phase 2 study testing JBI-802 and Pembrolizumab in people with Lung Cancer (NSCLC), run by The Christ Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (NSCLC)
- What is being tested?
- JBI-802 and Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2025to Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- 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.
- 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.
Who cannot join
- 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.
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- 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.
- Known active human immunodeficiency viruses infection or active infection with hepatitis B or C.
- Active gastrointestinal disease (eg, Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would reasonably impact drug absorption.
- Acute illness within 14 days prior to IP dosing unless mild in severity and approved by the Principal Investigator.
- Presence of active infection requiring antibiotics.
- Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the Screening Visit through 90 days after the last dose of trial treatment.
- Current participation in another clinical study of an investigational agents. Simultaneous participation in observational studies is acceptable after Principal Investigator approval.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Christ Hospital
Cincinnati, Ohio, 45219
Abby Reed, 513-585-0844, abby.reed@thechristhospital.com
Alexander Starodub, MD, PhD
About this study
Official title: 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
The purpose of this study is to determine the overall safety and tolerability of JBI-802 as single agent and in combination with Pembrolizumab.
Read the detailed description
This is a single site, open-label, study to define the safety profile and overall response rate (ORR) and duration of response (DOR) activity of JBI-802 alone and in combination with Pembrolizumab in participants with Non-Small Cell Lung Cancer harboring an STK11 mutation. Dose of study medication will be 10 mg orally once daily, 4 days on and 3 days off cycle. Dose of Pembrolizumab will be 200mg every 3 weeks.
- Conditions
- Lung Cancer (NSCLC)
- Being tested
- JBI-802, Pembrolizumab
- Keywords
- STK11 Mutation, NSCLC, Lung Cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JBI-802Drug
LSD1/HDAC6 Inhibitor
PembrolizumabDrug
PD-1
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy | Experimental | JBI-082 Single Agent Receives: Drug: JBI-802 |
| Combination | Experimental | JBI-802 plus Pembrolizumab Receives: Drug: JBI-802; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Up to 28 days from last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start29 Apr 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Christ Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Starodub, The Christ Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207395
- Sponsor's protocol ID
- 2024-001
- Status last verified
- Oct 2025
- First submitted
- 2 Oct 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07207395
- Acronym / sponsor ID
- 2024-001
- Conditions
- Lung Cancer (NSCLC)
- Keywords
- STK11 Mutation, NSCLC, Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Christ HospitalUniversity, hospital or other
- Study start
- 29 Apr 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the overall safety and tolerability of JBI-802 as single agent and in combination with Pembrolizumab.
Detailed description
This is a single site, open-label, study to define the safety profile and overall response rate (ORR) and duration of response (DOR) activity of JBI-802 alone and in combination with Pembrolizumab in participants with Non-Small Cell Lung Cancer harboring an STK11 mutation. Dose of study medication will be 10 mg orally once daily, 4 days on and 3 days off cycle. Dose of Pembrolizumab will be 200mg every 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monotherapy | Experimental | Drug: JBI-802JBI-082 Single Agent |
| Combination | Experimental | Drug: JBI-802, Drug: PembrolizumabJBI-802 plus Pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
- 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).
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JBI-802LSD1/HDAC6 Inhibitor | Drug | Combination, Monotherapy |
| PembrolizumabPD-1 | Drug | Combination |
Primary outcome
Incidence of Adverse Events
Time frame: Up 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 ORR
Time frame: Up 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JBI-802 and Pembrolizumab in people with Lung Cancer (NSCLC), run by The Christ Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abby Reed (513-585-0844, abby.reed@thechristhospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (time frame: Up to 28 days after last dose of study drug). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.