RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 evaluated in phase 2 in patients with solid tumors of neuroendocrine differentiation.

Official Title

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

Quick Facts

Study Start:2022-04-08

Study Completion:2025-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05268666

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 * 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. * 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.	* 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

Inclusion Criteria

Exclusion 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
* 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.
* 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.

* 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

Contacts and Locations

Study Contact

Chief Scientific Officer

CONTACT

(443) 515-9637

luca.rastelli@jubilanttx.com

Director, Program Management

CONTACT

rajeev.mohan@jubilanttx.com

Principal Investigator

Program Manager

STUDY_DIRECTOR

Jubilant Therapeutics Inc.

Study Locations (Sites)

Sarah Cannon Research Institute at HealthOne

Denver, Colorado, 82018

United States

The Christ Hospital

Cincinnati, Ohio, 45219

United States

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203

United States

NEXT Virginia, LLC

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: Jubilant Therapeutics Inc.

Program Manager, STUDY_DIRECTOR, Jubilant Therapeutics Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-08

Study Completion Date2025-08

Study Record Updates

Study Start Date2022-04-08

Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

SCLC
neuroendocrine prostate cancer
neuroendocrine
JBI-802

Additional Relevant MeSH Terms

Locally Advanced Solid Tumor
Metastatic Solid Tumor