RecruitingPhase 1Phase 2NCT06386146

JAB-30355 in Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation

A Phase 1/2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-30355 in Adult Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation


Sponsor

Jacobio Pharmaceuticals Co., Ltd.

Enrollment

144 participants

Start Date

Jul 24, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is to evaluate the efficacy and safety of JAB-30355 in adult participants with advanced solid tumors harboring TP53 Y220C mutation.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called JAB-30355 in people with advanced solid tumors that carry a specific genetic mutation called TP53 Y220C — a mutation that disrupts the body's normal tumor-suppressing mechanism. This drug is designed to restore the function of the mutated p53 protein. **You may be eligible if...** - You are 18 or older - You have confirmed advanced solid tumor cancer with a TP53 Y220C mutation - You have already received at least one previous line of treatment - You are in generally good health (ECOG 0–1) - You have at least one measurable tumor - You can swallow and absorb oral medication **You may NOT be eligible if...** - You have active brain or spinal cord metastases - You have an active serious infection requiring treatment - You have active hepatitis B or C - You have a reduced heart pumping function (LVEF 50% or below) - You have a prolonged heart QT interval on ECG Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJAB-30355

Oral administration

DRUGJAB-30355

Oral administration


Locations(13)

Research Site

Denver, Colorado, United States

Research site

Lake Mary, Florida, United States

Research site

St Louis, Missouri, United States

Research site

Canton, Ohio, United States

Research site

Cleveland, Ohio, United States

Research Site

Nashville, Tennessee, United States

Research site

Houston, Texas, United States

Research Site

Beijing, Beijing Municipality, China

Research Site

Beijing, Beijing Municipality, China

Research Site

Beijing, Beijing Municipality, China

Research Site

Guangzhou, Guangdong, China

Research Site

Jinan, Shandong, China

Research Site

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06386146


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