NCI-2025-02229

A Multicenter First-in-human Dose Escalation and Optimization Phase I/IIa Trial to Investigate Safety, Tolerability, Pharmacokinetics, and Efficacy of the 5T4 Antibody-Drug Conjugate TUB-030 in Patients with Advanced Solid Tumors (5-STAR 1-01)

The 5-STAR 1-01 study is a first-in-human, multicenter, Phase I/IIa research study testing a new investigational drug called TUB-030, which is a 5T4 antibody–drug conjugate (ADC). The trial focuses on people with advanced solid tumors—cancers that have spread or no longer respond to standard treatments. TUB-030 is designed to target a protein called 5T4, which is often found on the surface of many cancer cells but is usually low in normal tissues. Once the drug binds to cancer cells carrying the 5T4 marker, it delivers a powerful chemotherapy payload directly into those cells, aiming to destroy them while limiting harm to healthy tissue. The overall goal is to determine whether TUB-030 could become a new targeted therapy option for patients with advanced cancers that express the 5T4 protein.

Phase I/IIa: A study that assesses the safety, effectiveness, and how well the treatment works

antibody–drug conjugate (ADC): an antibody that targets cancer cells and a chemotherapy drug that kills cancer cells.

For more information about the trial, click the link below:

https://clinicaltrials.gov/ct2/show/NCT06657222

Clinical Trial Site: Sinai

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