Study on JAB-30355 for Adults with Advanced Solid Tumors with TP53 Y220C Mutation

Sponsor: Jacobio Pharmaceuticals Co., Ltd.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06386146

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, JAB-30355, in adults with advanced solid tumors that have a specific genetic mutation called TP53 Y220C.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well the drug JAB-30355 works and how safe it is for adults with advanced solid tumors that have the TP53 Y220C mutation. The study is divided into two parts: the first part will determine the safest dose of the drug, and the second part will explore its benefits and safety at selected doses.

Description

This study is divided into two phases. In the first phase, researchers will test different doses of JAB-30355 to find the safest amount that can be given to patients with advanced solid tumors that have the TP53 Y220C mutation. This phase will focus on understanding any side effects and how well patients tolerate the drug. In the second phase, the study will look more closely at how effective the drug is at these selected doses and continue to monitor its safety. Participants will receive the drug and undergo regular health checks to track their response and any side effects.

Eligibility Criteria

Inclusion Criteria

  • Must provide written informed consent to participate.
  • Must be 18 years or older.
  • Must be in good overall health, with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Must have received at least one previous treatment for their type and stage of cancer.
  • Must have a confirmed TP53 Y220C mutation in their cancer.
  • Must have at least one tumor that can be measured by scans.
  • Must have good blood, kidney, and liver function, and normal blood clotting.
  • Must be able to swallow pills.

Exclusion Criteria

  • Have active cancer that has spread to the brain or spine, or have a primary brain tumor.
  • Have an active infection that requires treatment within the past week.
  • Have active hepatitis B or C infections.
  • 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).

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.