Study on JAB-2485 for Adults with Advanced Solid Tumors

Sponsor: Jacobio Pharmaceuticals Co., Ltd.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05490472

Provider View

This clinical trial is testing the safety and tolerability of a new drug, JAB-2485, in adults with advanced solid tumors. The study aims to find the best dose and evaluate its potential to reduce tumors in various cancers.

Patient Parameters

Program Overview

The purpose of this study is to determine if JAB-2485 is safe and well-tolerated in adults with advanced solid tumors. Researchers will first find the highest dose that can be given safely and then test this dose to see if it can help shrink tumors in patients with specific types of cancer, including certain breast cancers and small cell lung cancer.

Description

This study is divided into two phases. In the first phase, researchers will test different doses of JAB-2485 to find the maximum dose that patients can tolerate without severe side effects. In the second phase, they will use this dose to see if the drug can help reduce tumors in patients with advanced solid tumors, such as estrogen receptor-positive breast cancer, triple-negative breast cancer, ARID1A mutant tumors, and small cell lung cancer. Participants will be closely monitored for any side effects and their response to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Be able to provide a previous tumor sample for analysis.
  • Have a confirmed diagnosis of metastatic or advanced solid tumor based on lab tests.
  • For the second phase, meet specific genetic or expression criteria if required.
  • Have not responded to or cannot tolerate existing treatments that are known to help their condition.
  • Have at least one measurable tumor that can be tracked using standard criteria.
  • Have good organ function as determined by blood and other tests.
  • Be able to swallow and retain oral medication.

Exclusion Criteria

  • Have cancer that has spread to the brain or spinal cord, unless treated and stable for at least 28 days.
  • Have an active infection that requires treatment within the past week.
  • Have active hepatitis B, hepatitis C, or HIV.
  • Have any severe or uncontrolled medical conditions.
  • Have a heart's left ventricle pumping ability of 50% or lower.
  • Have a prolonged QT interval on an ECG (QTcF greater than 470 milliseconds).
  • Have unresolved side effects from previous treatments that are moderate or severe.
  • Have significant eye disorders.

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