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

NCT05268666 | Unknown Phase 1 FDA Drug

• 1 other identifier: JBI-802-101
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 4

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

Conditions

Locally Advanced Solid Tumor; Metastatic Solid Tumor

Keywords

SCLC; neuroendocrine prostate cancer; neuroendocrine; JBI-802

Outcome Measures

Primary Outcomes (2)

• Maximum-Tolerated Dose (MTD)

  28-day cycle

• Investigator-Assessed ORR (Part 2)

  Defined as either complete response (CR) or partial response (PR) as defined by RECIST version 1.1

  Up to 30 days from the last dose of study drug

Secondary Outcomes (14)

• Incidence of AEs

  Up to 30 days from the last dose of study drug

• Cmax: Maximum Plasma Concentration JBI-802

  Baseline up to 28 days from the last dose of study drug

• Tmax: Time of Maximum Plasma Concentration JBI-802

  Baseline up to 28 days from the last dose of study drug

• Clast: Last Observed (quantifiable) Plasma Concentration in units of ng/mL JBI-802

  Baseline up to 28 days from the last dose of study drug

• AUC(0-last): Area Under the Concentration-time Curve from Dosing (time 0) to Time of Last Measured Concentration JBI-802

  Baseline up to 28 days from the last dose of study drug

Study Arms (1)

JBI-802

EXPERIMENTAL

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

Drug: JBI-802

Interventions

JBI-802 DRUG

LSD1/HDAC6 inhibitor

JBI-802

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jubilant Therapeutics Inc.: lead

Study Sites (4)

Sarah Cannon Research Institute at HealthOne

Denver, Colorado, 82018, United States

COMPLETED

The Christ Hospital

Cincinnati, Ohio, 45219, United States

RECRUITING

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

COMPLETED

NEXT Virginia, LLC

Fairfax, Virginia, 22031, United States

COMPLETED

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Program Manager

  Jubilant Therapeutics Inc.

  STUDY DIRECTOR

Central Study Contacts

Chief Scientific Officer

CONTACT

(443) 515-9637; luca.rastelli@jubilanttx.com

Director, Program Management

CONTACT

rajeev.mohan@jubilanttx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: March 7, 2022
• Study Start: April 8, 2022
• Primary Completion: December 1, 2024
• Study Completion: August 1, 2025
• Last Updated: June 15, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)