A Study of Orally Administered JBI-802, an LSD1/HDAC6 Inhibitor, in Patients With Advanced Solid Tumors

Launched by JUBILANT THERAPEUTICS INC. · Feb 24, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called JBI-802, which is taken by mouth. It is designed for patients with advanced solid tumors, which are abnormal growths that can spread to other parts of the body. The main goal of this trial is to find out the highest dose of JBI-802 that patients can safely take and to determine the best dose for future studies. The trial is currently looking for participants, particularly those with specific types of tumors that have not responded to other treatments.

To join the study, participants need to be at least 18 years old and have a measurable tumor. They should also be in reasonably good health, with certain blood counts and liver function levels within acceptable ranges. However, there are some conditions that might exclude someone from participating, such as severe heart problems or certain types of brain tumors. If eligible, participants can expect to receive the medication and be monitored closely for its effects and any side effects. This is an important step in understanding how JBI-802 can help treat difficult-to-manage cancers.

Gender

ALL

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