Status:
UNKNOWN
A Study of Orally Administered JBI-802, an LSD1/HDAC6 Inhibitor, in Patients With Advanced Solid Tumors
Lead Sponsor:
Jubilant Therapeutics Inc.
Conditions:
Locally Advanced Solid Tumor
Metastatic Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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.The efficacy of the RP2D will be evalua...
Detailed Description
This is a multi-center, first in human, open-label, 2-part, dose escalation and expansion study to define safety, tolerability, maximum tolerated dose, pharmacologically active dose, assess preliminar...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT05268666
Start Date
April 8 2022
End Date
August 1 2025
Last Update
June 15 2023
Active Locations (4)
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1
Sarah Cannon Research Institute at HealthOne
Denver, Colorado, United States, 82018
2
The Christ Hospital
Cincinnati, Ohio, United States, 45219
3
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37203
4
NEXT Virginia, LLC
Fairfax, Virginia, United States, 22031