JBI-802 for Solid Tumors

Not currently recruiting at 1 trial location

Overseen By Director, Program Management

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Jubilant Therapeutics Inc.

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

Disqualifiers: CNS disease, Heart failure, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called JBI-802, an experimental drug, to determine the optimal dose and assess its effectiveness for individuals with advanced solid tumors, particularly those with neuroendocrine differentiation. Participants take JBI-802 in cycles of four days on, three days off. The trial suits individuals with advanced solid tumors who lack effective treatment options, such as those with small cell lung cancer or specific neuroendocrine tumors. Participants must have a measurable tumor and no severe health issues that could complicate treatment. As a Phase 1/Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants the chance to contribute to groundbreaking cancer research.

Will I have to stop taking my current medications?

The trial requires you to stop using strong inhibitors or inducers of certain enzymes (CYP3A and CYP2D6) at least 14 days before starting the study. If you're on anticoagulants, you must be on a stable dose for at least 2 weeks before joining. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Is there any evidence suggesting that JBI-802 is likely to be safe for humans?

Research shows that JBI-802 is generally well-tolerated by patients with advanced solid tumors. Studies indicate it has a good safety profile, meaning it usually doesn't cause serious side effects. Notably, JBI-802 can lead to a decrease in platelets, which are blood cells that help with clotting. However, this effect depends on the dose and can be reversed.

Some patients have experienced a more significant drop in platelets, known as grade 3/4 thrombocytopenia. Fortunately, this has not affected hemoglobin levels, which is positive because it means there are no issues with blood oxygen levels. Overall, early studies suggest JBI-802 is safe for humans, but ongoing trials will provide more detailed information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about JBI-802 for treating solid tumors because it offers a new approach compared to existing options. Unlike traditional chemotherapy or targeted therapies, JBI-802 works by a unique mechanism, involving a four days on, three days off dosing cycle, which could potentially enhance effectiveness and reduce side effects. This treatment specifically targets the epigenetic regulators involved in tumor growth, which may lead to better outcomes for patients who haven't responded well to conventional treatments. If successful, JBI-802 could represent a significant advancement in the fight against solid tumors, providing a more tailored and possibly more effective treatment option.

What evidence suggests that JBI-802 might be an effective treatment for solid tumors?

Research has shown that JBI-802, the investigational treatment in this trial, exhibits strong anti-cancer effects. It blocks specific proteins, LSD1 and HDAC6, which aid cancer growth. Early animal tests demonstrated that JBI-802 effectively shrinks tumors. In one patient with advanced cancer, the treatment reduced liver tumors by more than 50%, significantly decreasing the cancer in the liver. These results suggest that JBI-802 could effectively treat advanced cancers. ^{1 3 6 7 8}

Who Is on the Research Team?

Program Manager

Principal Investigator

Jubilant Therapeutics Inc.

Are You a Good Fit for This Trial?

Adults with advanced solid tumors that can't be surgically removed or have spread, and who lack effective treatment options. They must have a certain level of organ function and no severe medical conditions or recent use of specific drugs that affect metabolism.

Inclusion Criteria

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

Exclusion Criteria

I haven't taken strong CYP2D6 inducers recently.

My brain metastases are stable and I haven't taken steroids for them in the last 14 days.

I have had surgery or a condition that affects how my body absorbs medicine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of JBI-802 to determine the maximum-tolerated dose (MTD)

4-8 weeks

Weekly visits (in-person)

Dose Expansion

Participants receive the recommended Phase 2 dose (RP2D) to evaluate efficacy in specific cancer types

Up to 30 months

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 30 days from the last dose

What Are the Treatments Tested in This Trial?

Interventions

• JBI-802

Trial Overview The trial is testing JBI-802, an oral drug for advanced solid tumors. It aims to find the highest dose patients can take without serious side effects (MTD) and the optimal dose for further studies (RP2D). Phase 2 will assess its effectiveness in certain tumor types.

How Is the Trial Designed?

Group I: JBI-802 Experimental Treatment 1 Intervention

10 mg JBI-802 once daily as the starting dose with 4 days on/3 days off cycle

Who Is Running the Clinical Trial?

Jubilant Therapeutics Inc.

Lead Sponsor

Trials

1

Recruited

130+

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

JBI-802 Demonstrates Preliminary Activity in Advanced ... In this patient, treatment with JBI-802 led to greater than 50% shrinkage of the liver metastasis and a complete resolution of related portal ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07207395

NCT07207395 | A Study of Orally Administered JBI-802 ... This is a single site, open-label, study to define the safety profile and overall response rate (ORR) and duration of response (DOR) ...

4. anzctr.org.au anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12624000478516

actrn12624000478516 JBI-802 has shown promising results in its series of in vitro and in vivo primary pharmacology studies, biochemical and cellular assays, in vitro proliferation ...

5. trial.medpath.com trial.medpath.com/clinical-trial/d44a40177d1d3579/first-in-human-open-label-study-jbi-802

A Study of Orally Administered JBI-802, an LSD1/HDAC6 ... The purpose of this study is to determine the maximum-tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of JBI-802 in patients with Advanced Solid ...

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 ... Conclusion: JBI-802 in its first-in-human study in patients with solid tumors demonstrated a dose dependent, reversible decrease in platelets which at the ...

7. jubilanttx.com jubilanttx.com/pressreleasedetails.aspx?mpgid=1473&pgid=1475&pressid=470

Press Releases | News The Phase 1/2a trial is an open-label, two-part dose escalation and expansion study designed to define the safety profile and preliminary activity of JBI-802 in ...

8. cancer.gov cancer.gov/clinicaltrials/NCI-2023-00374

A Study of Orally Administered JBI-802, an LSD1/HDAC6 ... The purpose of this study is to determine the maximum-tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of JBI-802 in patients with Advanced Solid Tumors ...