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JBI-802 for Solid Tumors
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- My prostate cancer is newly diagnosed or has changed form.I haven't taken strong CYP2D6 inducers recently.I have advanced small cell lung cancer, treated with no more than 2 prior therapies including a checkpoint inhibitor and platinum-based chemotherapy.My brain metastases are stable and I haven't taken steroids for them in the last 14 days.My kidneys are functioning well, with a creatinine clearance rate of 60 mL/min or higher.I am 18 years old or older.I have an advanced neuroendocrine tumor that cannot be surgically removed and no treatments have worked.I have had surgery or a condition that affects how my body absorbs medicine.I do not have severe heart problems, uncontrolled high blood pressure, diabetes, or serious mental health issues.My blood clotting times are normal or near normal, and if I'm on blood thinners, my dose has been stable for 2 weeks.I haven't taken strong CYP2D6 inhibitors recently.I haven't taken strong CYP3A inducers recently.I have an advanced cancer (not colorectal or liver cancer) with no treatment options left.I haven't taken strong CYP3A inhibitors or consumed grapefruit products recently.I don't have another cancer that would affect this treatment's safety or results.I can take care of myself but might not be able to do heavy physical work.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
- Group 1: JBI-802
Frequently Asked Questions
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."
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."
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."
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."
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