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LSD1/HDAC6 Inhibitor

JBI-802 for Solid Tumors

Phase 1 & 2
Recruiting
Research Sponsored by Jubilant Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
De novo or treatment-emergent NEPC
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up date patient started study drug to date of progression, assessed up to 30 months
Awards & highlights

Study Summary

This trial is testing a new drug to see what dose is safe and effective for treating patients with advanced solid tumors. The study will also look at how well the drug works in patients with tumors that originate from neuroendocrine cells.

Who is the study for?
Adults with advanced solid tumors that can't be surgically removed or have spread, and who lack effective treatment options. They must have a certain level of organ function and no severe medical conditions or recent use of specific drugs that affect metabolism.Check my eligibility
What is being tested?
The trial is testing JBI-802, an oral drug for advanced solid tumors. It aims to find the highest dose patients can take without serious side effects (MTD) and the optimal dose for further studies (RP2D). Phase 2 will assess its effectiveness in certain tumor types.See study design
What are the potential side effects?
Specific side effects are not listed but may include typical reactions to cancer medications such as nausea, fatigue, blood count changes, liver enzyme alterations, and potential drug-specific effects which will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer is newly diagnosed or has changed form.
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I have advanced small cell lung cancer, treated with no more than 2 prior therapies including a checkpoint inhibitor and platinum-based chemotherapy.
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My kidneys are functioning well, with a creatinine clearance rate of 60 mL/min or higher.
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I have an advanced neuroendocrine tumor that cannot be surgically removed and no treatments have worked.
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I have an advanced cancer (not colorectal or liver cancer) with no treatment options left.
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I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~date patient started study drug to date of progression, assessed up to 30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and date patient started study drug to date of progression, assessed up to 30 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Investigator-Assessed ORR (Part 2)
Maximum-Tolerated Dose (MTD)
Secondary outcome measures
AUC(0-last): Area Under the Concentration-time Curve from Dosing (time 0) to Time of Last Measured Concentration JBI-802
AUC(0-t) (partial AUC): Area Under the Concentration-time Curve from Dosing (time 0) to Time t JBI-802
CL/F: Apparent Oral Clearance (CL/F) computed as Dose/AUC
+11 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: JBI-802Experimental Treatment1 Intervention
10 mg JBI-802 once daily as the starting dose with 4 days on/3 days off cycle

Find a Location

Who is running the clinical trial?

Jubilant Therapeutics Inc.Lead Sponsor
Program ManagerStudy DirectorJubilant Therapeutics Inc.

Media Library

JBI-802 (LSD1/HDAC6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05268666 — Phase 1 & 2
Solid Tumors Clinical Trial 2023: JBI-802 Highlights & Side Effects. Trial Name: NCT05268666 — Phase 1 & 2
JBI-802 (LSD1/HDAC6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05268666 — Phase 1 & 2
Solid Tumors Research Study Groups: JBI-802

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many healthcare facilities are currently conducting this experiment?

"Patients can be recruited for this trial from NEXT Virginia, LLC in Fairfax, SCRI - Tennessee Oncology- Nashville – Centennial in Denver and Sarah Cannon Research Institute at HealthOne in Cincinnati. Additionally there are 5 other sites that are hosting recruitment efforts."

Answered by AI

Are there any openings currently available in this trial for potential participants?

"Yes, according to the clinicaltrials.gov database this study began recruitment on April 8th 2022 and is still seeking participants. The trial intends to enroll 126 individuals between 5 distinct sites."

Answered by AI

What is the primary objective of this investigational research?

"The main aim of this clinical investigation, measured over the course of a month from the final dose administered, is to determine Maximum-Tolerated Dose (MTD). As secondary objectives, Progression Free Survival (PFS), Investigator-Assessed Overall Response Rate (ORR) and Last Observed Plasma Concentration in units of ng/mL JBI-802 will be assessed."

Answered by AI

To what capacity is this trial recruiting participants?

"To properly run this research study, a total of 126 participants who fit the inclusion criteria need to be identified. Jubilant Therapeutics Inc. is responsible for ensuring successful execution and will use NEXT Virginia LLC in Fairfax, VA and SCRI - Tennessee Oncology-Nashville – Centennial in Denver, CO as sites for clinical trials."

Answered by AI
~33 spots leftby Dec 2024