RecruitingPhase 1NCT06223542

Studying TAK-243 in Patients With Advanced Cancer

A Phase I Study to Investigate the Safety of the Ubiquitin Activating Enzyme Inhibitor TAK-243 in Adult Solid Tumor and Lymphoma Patients


Sponsor

National Cancer Institute (NCI)

Enrollment

95 participants

Start Date

Mar 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial studies the side effects and best dose of ubiquitin-activating enzyme (UAE) inhibitor TAK-243 (TAK-243) in treating patients with a solid tumor that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic) and in patients with lymphoma. TAK-243 is a drug that binds to and inhibits the ubiquitin-activating enzyme, an enzyme that is more active on cancer cells than healthy cells, inhibiting tumor cell proliferation and survival.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an experimental drug called TAK-243 in adults with advanced solid tumors or aggressive lymphomas that have not responded to standard treatments. TAK-243 works by blocking a cellular process that cancer cells depend on to manage damaged proteins. **You may be eligible if...** - You are 18 years old or older - You have advanced or metastatic solid tumors that have failed standard therapies, OR you have an aggressive lymphoma that has failed at least 2 prior treatment regimens - Your cancer is measurable on imaging - Your blood counts, liver, and kidney function are adequate - You are willing to use contraception during and for 4 months after treatment **You may NOT be eligible if...** - You have uncontrolled heart disease (heart failure, recent heart attack, serious arrhythmia) - You have severe lung disease (COPD, pulmonary fibrosis) - You are pregnant or breastfeeding - You have known brain metastases that are unstable - You have cirrhosis or severe liver disease - You are currently taking strong inhibitors or inducers of certain liver enzymes (CYP3A4) 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

PROCEDUREBiopsy Procedure

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo collection of blood

PROCEDUREComputed Tomography

Undergo CT

PROCEDUREEchocardiography Test

Undergo ECHO

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

DRUGUAE Inhibitor TAK-243

Given IV


Locations(1)

National Cancer Institute Developmental Therapeutics Clinic

Bethesda, Maryland, United States

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NCT06223542


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