Recruiting
Phase 1
Phase 2

JBI-802

Sponsor:

Jubilant Therapeutics Inc.

Code:

NCT05268666

Conditions

Locally Advanced Solid Tumor

Metastatic Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

JBI-802

Study Details

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

Study ID

NCT05268666

Start date

Apr 8, 2022

Status verified date

Aug, 2022

Completion date

Aug, 2025

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

126 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: JBI-802

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

Interventions

JBI-802

LSD1/HDAC6 inhibitor

Primary outcome measure

  • Maximum-Tolerated Dose (MTD) [ Time Frame: 28-day cycle ]
  • Investigator-Assessed ORR (Part 2) [ Time Frame: Up to 30 days from the last dose of study drug ]

Central Contacts and Locations

Central contacts

Chief Scientific Officer

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

Director, Program Management

rajeev.mohan@jubilanttx.com

Locations

The Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

More Information

Sponsor

Jubilant Therapeutics Inc.

Last update posted

Jun 15, 2023

Last verified

Aug, 2022

Keywords

  • SCLC
  • neuroendocrine prostate cancer
  • neuroendocrine
  • JBI-802

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jubilant Therapeutics Inc. on 2023-06-15.