JBI-802 + Pembrolizumab for Lung Cancer

Overseen By Abby Reed

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: The Christ Hospital

Must not be taking: CYP3A inhibitors, CYP3A inducers, CYP2D6 inhibitors, CYP2D6 inducers

Disqualifiers: Uncontrolled hypertension, Diabetes, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Varies

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the safety and tolerability of JBI-802, an experimental treatment, used alone or with Pembrolizumab, an immunotherapy drug, for lung cancer. It specifically targets individuals with advanced lung cancer that has a specific STK11 mutation. Eligible participants have this type of lung cancer and at least one measurable tumor visible on a CT scan or MRI. This trial offers an opportunity to evaluate the potential effectiveness of this new treatment combination against lung cancer. As a Phase 2 trial, the research focuses on measuring the treatment's efficacy in an initial, smaller group of participants.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop all current medications, but you must not have taken certain cancer treatments or investigational drugs within 2 weeks before starting the study. Also, you should not use strong inhibitors or inducers of specific enzymes (CYP3A and CYP2D6) within 14 days before the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that JBI-802, a new cancer drug, is generally well tolerated, with most patients not experiencing serious side effects. The main issue observed was a decrease in platelets, which are cells that help blood clot, at the highest doses. This decrease was reversible, returning to normal after the dose was lowered.

Pembrolizumab, sometimes used with JBI-802 in studies, is already approved for treating lung cancer. Many studies confirm its safety and effectiveness for this type of cancer. Researchers are now investigating whether combining it with JBI-802 is both effective and safe.

This trial is in its second phase, indicating that some safety information from earlier studies is already available. This phase further confirms the safety and tolerability of these treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because JBI-802, in combination with Pembrolizumab, offers a potentially powerful new approach to treating lung cancer. Unlike current treatments like chemotherapy and radiation, which can affect both cancerous and healthy cells, JBI-802 specifically targets cancer cells, potentially reducing side effects. When paired with Pembrolizumab, an immunotherapy drug that helps the immune system attack cancer, this combination could enhance the body's natural ability to fight cancer more effectively. This innovative approach has the potential to improve outcomes for patients who may not respond well to existing therapies.

What evidence suggests that this trial's treatments could be effective for lung cancer?

Studies have shown that JBI-802, a new drug, has strong effects against tumors in early research. It targets specific proteins that aid cancer growth. Early studies suggest that JBI-802 might enhance tumor responsiveness to immune-based treatments, particularly in hard-to-treat cancers. In this trial, some participants will receive JBI-802 alone, while others will receive a combination of JBI-802 and Pembrolizumab. Pembrolizumab is already known to extend survival in certain lung cancer patients. Combining these treatments could provide a new approach to fighting lung cancer. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with non-small cell lung cancer that has a specific mutation called STK11. The details on who can join are not fully provided, but typically participants need to meet certain health standards and have not been treated with similar drugs before.

Inclusion Criteria

Screening laboratory values: 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

Must have at least one measurable lesion on CT scan or MRI per RECIST 1.1

Willing and able to give informed consent and comply with protocol requirements for the duration of the study

Exclusion Criteria

Acute illness within 14 days prior to IP dosing unless mild in severity and approved by the Principal Investigator

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive JBI-802 alone or in combination with Pembrolizumab. JBI-802 is administered 10 mg orally once daily, 4 days on and 3 days off cycle. Pembrolizumab is administered 200mg every 3 weeks.

Varies

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and overall response rate.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• JBI-802
• Pembrolizumab

Trial Overview The study is testing the safety and how well people tolerate JBI-802 when taken alone or together with Pembrolizumab, which is an existing treatment for this type of cancer. It's likely that patients will be randomly assigned to receive either just JBI-802 or both medications.

How Is the Trial Designed?

Group I: Monotherapy Experimental Treatment 1 Intervention

JBI-082 Single Agent

Group II: Combination Experimental Treatment 2 Interventions

JBI-802 plus Pembrolizumab

Who Is Running the Clinical Trial?

The Christ Hospital

Lead Sponsor

Trials

20

Recruited

1,400+

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.TPS6589

Anti-tumor activity of CoREST inhibitor, JBI-802 (dual ... JBI-802 is a highly potent CoREST inhibitor with LSD1/HDAC6 selective dual inhibition that shows superior anti-tumor activity in several pre-clinical models.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07207395

A Study of Orally Administered JBI-802 Alone or in ... This is a single site, open-label, study to define the safety profile and overall response rate (ORR) and duration of response (DOR) ...

3. onclive.com onclive.com/view/jbi-802-demonstrates-preliminary-activity-in-advanced-solid-tumors

JBI-802 Demonstrates Preliminary Activity in Advanced ... Treatment with JBI-802, the first-in-class CoREST inhibitor with dual LSD1 and HDAC6 activity was shown to be safe and active.

4. rarediseaseadvisor.com rarediseaseadvisor.com/news/promising-preliminary-phase-1-data-of-jbi-802-mds/

Promising Preliminary Phase 1 Data for JBI-802 in Treating ... Phase 1 data for JBI-802 suggest therapeutic potential in sensitizing immunotherapy-resistant tumors and in myelodysplastic syndromes (MDS).

5. jubilanttx.com jubilanttx.com/pressreleasedetails.aspx?mpgid=1473&pgid=1475&pressid=504

Press Releases | News JBI-802 initial Phase I data suggests therapeutic potential in sensitizing immunotherapy resistant tumors and in Myeloproliferative Neoplasms with ...

6. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/6648/528575/JBI802-a-Highly-Potent-Corest-Inhibitor

JBI802 a Highly Potent Corest Inhibitor Demonstrated Anti ... Overall, JBI-802 was well tolerated with good safety profile, with grade 3/4 thrombocytopenia as the only adverse event observed at the highest dose. Dose- ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497124094746

JBI802 a Highly Potent Corest Inhibitor Demonstrated Anti- ... JBI-802 in its first-in-human study in patients with solid tumors showed a dose dependent, reversible decrease in platelets which at the highest dose resulted ...