Oral treatment with JBI-802 for advanced solid tumors

A First-in-Human, Open-label, Dose Escalation and Expansion Study of Orally Administered JBI-802 in Patients With Advanced Solid Tumors

This study is testing a new oral medication called JBI-802 to see if it can help people with advanced solid tumors, including small cell lung cancer and neuroendocrine prostate cancer.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 126 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Jubilant Therapeutics Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 4 sites (Denver, Colorado and 3 other locations)
• Trial ID: NCT05268666 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of JBI-802, an LSD1/HDAC6 inhibitor, in patients with advanced solid tumors. It consists of two phases: a dose escalation phase to determine the maximum tolerated dose (MTD) and a subsequent expansion phase to assess the recommended Phase 2 dose (RP2D) in specific cancer types, including small cell lung cancer and neuroendocrine prostate cancer. The study aims to enroll up to 126 participants and will explore biomarkers related to treatment response. Participants will take the medication orally on a specific dosing schedule.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed locally advanced or metastatic solid tumors and specific laboratory criteria.

Not a fit: Patients with microsatellite stable colorectal cancer or those with significant comorbidities affecting eligibility may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors, particularly those with neuroendocrine differentiation.

How similar studies have performed: While this approach is novel, similar studies targeting LSD1 and HDAC6 have shown promise in early-phase trials.

Eligibility criteria

Inclusion Criteria:

* Males or females aged ≥18 years at Screening
* 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) ≥60 mL/min (Cockcroft-Gault formula).
* 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
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
* Other criteria may apply

Part 1:

* Participants with a histologically confirmed diagnosis of locally advanced or metastatic solid tumors (except microsatellite stable colorectal cancer and hepatocellular carcinoma) who have no available effective therapeutic options.

Part 2:

* Small cell lung cancer: Participants must have a histologic diagnosis of advanced SCLC not amenable to curative therapy and have received ≤2 prior regimens, which must have included a checkpoint inhibitor and a platinum-based chemotherapy.
* De novo or treatment-emergent NEPC
* Basket of neuroendocrine-derived tumors, excluding SCLC and treatment-induced NEPC. Participants must have unresectable locally advanced or metastatic disease and have no available effective therapeutic options.

Exclusion Criteria:

* Known malignant central nervous system (CNS) 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 Class 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.
* Use of strong inhibitors of 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.
* History of other previous or concurrent cancer that would interfere with the determination of safety or efficacy assessment
* Surgery (eg, stomach bypass) or medical condition that might significantly affect absorption of medicines
* Other criteria may apply

Where this trial is running

Denver, Colorado and 3 other locations

• Sarah Cannon Research Institute at HealthOne — Denver, Colorado, United States (Completed)
• The Christ Hospital — Cincinnati, Ohio, United States (Recruiting)
• Tennessee Oncology, PLLC — Nashville, Tennessee, United States (Completed)
• NEXT Virginia, LLC — Fairfax, Virginia, United States (Completed)

Study contacts

• Study coordinator: Chief Scientific Officer

Conditions Locally Advanced Solid Tumor; Metastatic Solid Tumor; SCLC; neuroendocrine prostate cancer; neuroendocrine; JBI-802