Study on Oral JBI-802 for Patients with Advanced Solid Tumors

Sponsor: Jubilant Therapeutics Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05268666

Provider View

This clinical trial is testing a new oral medication, JBI-802, to find the best dose and evaluate its effectiveness in treating advanced solid tumors, particularly those with neuroendocrine differentiation.

Patient Parameters

Program Overview

The study aims to determine the safest and most effective dose of JBI-802, a new oral drug, for patients with advanced solid tumors. In the second phase, the study will focus on patients with tumors that have neuroendocrine characteristics to see how well the drug works.

Description

This study is being conducted at multiple centers and is the first time JBI-802 is being tested in humans. It is an open-label study, meaning both the researchers and participants know what treatment is being given. The study has two parts: the first part will test different doses to find the maximum tolerated dose, and the second part will expand to include more patients to gather additional safety and effectiveness data. Up to 126 participants with advanced solid tumors will be involved. The study will include patients with small cell lung cancer, neuroendocrine prostate cancer, and other neuroendocrine-derived cancers. Participants will start with a dose of 10 mg taken orally once a day for four days, followed by a three-day break.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years or older.
  • Adequate blood cell counts and liver function as determined by specific blood tests.
  • Good kidney function with a creatinine clearance of at least 60 mL/min.
  • Ability to provide a tumor sample that can be measured by scans.
  • Good overall health with an ECOG performance status of 0 to 2.
  • For Part 1: Have advanced solid tumors with no effective treatment options available.
  • For Part 2: Have advanced small cell lung cancer, neuroendocrine prostate cancer, or other neuroendocrine-derived tumors with no effective treatment options.

Exclusion Criteria

  • Active cancer in the central nervous system, unless stable and treated.
  • Severe or unstable medical conditions, such as serious heart disease or uncontrolled diabetes.
  • Recent use of certain medications that affect how the body processes drugs.
  • History of other cancers that could interfere with the study.
  • Medical conditions that affect the absorption of oral medications.

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