Study on JAB-21822 for Adults with Advanced Solid Tumors with KRAS G12C Mutation

Sponsor: Jacobio Pharmaceuticals Co., Ltd.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05002270

Provider View

This clinical trial is testing the safety and effects of a new drug, JAB-21822, alone and in combination with another drug, cetuximab, in adults with advanced solid tumors that have a specific KRAS G12C mutation.

Patient Parameters

Program Overview

The purpose of this study is to determine if the drug JAB-21822 is safe and well-tolerated when used alone or with cetuximab in adults with advanced solid tumors that have the KRAS G12C mutation. Researchers will first find the best dose of JAB-21822 and then see how well it works against tumors.

Description

This study is focused on evaluating the safety and tolerability of JAB-21822, a new drug, in adults with advanced solid tumors that have a specific genetic mutation known as KRAS G12C. The study is divided into two phases. In the first phase, researchers will determine the safest and most effective dose of JAB-21822 when used alone. In the second phase, they will assess the drug's ability to fight tumors both on its own and in combination with another drug called cetuximab. Participants will be closely monitored for any side effects and the overall response of their tumors to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must provide a previous tumor sample for analysis.
  • Have a confirmed diagnosis of solid tumors with the KRAS G12C mutation.
  • Have received at least one prior standard treatment for their cancer.
  • Have at least one tumor that can be measured using standard criteria.
  • Have good organ function as determined by medical tests.
  • Must be able to swallow and keep down oral medication.

Exclusion Criteria

  • Have cancer that has spread to the brain or spine, unless treated and stable for at least 28 days.
  • Have an active infection needing treatment within the last 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).
  • Have unresolved side effects from previous treatments that are more than mild.

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