Recruiting

Telisotuzumab Adizutecan for Locally Advanced or Metastatic Solid Tumors with MET Amplification in Patients 12 Years and Older

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is being done in people with locally advanced or metastatic solid tumors that have MET amplification, which means the cancer cells have extra copies of a gene called MET. Telisotuzumab adizutecan will be given by vein as the study treatment. The purpose of the study is to learn more about the safety of this treatment and whether it may help control these cancers.

During the study, participants receive telisotuzumab adizutecan as a solution for infusion, which means it is given slowly through a vein. The study team follows participants over time to watch for adverse events, which are unwanted health problems or side effects, and to see how the cancer changes while on treatment. The study looks at how long any cancer response lasts, how long the cancer stays under control, and overall survival.

This is a Phase 2 study, which means it is an early study in a larger group of people after initial testing has already been done. It focuses on a single treatment, so no other study medicine is listed. The study is planned to continue for several years.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Study treatment begins
After joining the study, you receive telisotuzumab adizutecan as the study medicine.
The medicine is given by intravenous infusion, which means it is delivered through a vein.
The dose listed for the study medicine is 00 mg.
The medicine is given as a solution for infusion.
The study is designed to use telisotuzumab adizutecan alone, meaning no other study medicine is listed.
Step 2
Ongoing treatment period
You continue receiving telisotuzumab adizutecan by intravenous infusion during the study period.
The available information does not state the exact frequency of dosing or the exact duration of each infusion.
The available information does not state the total length of treatment for each patient.
Step 3
Checks during the trial
Your disease activity is checked during the study to see whether the cancer changes in size or behavior.
The main measure of benefit is objective response, which means how much the cancer shrinks or improves.
Other study checks include how long the response lasts, how long the disease stays under control, how long it takes before the disease gets worse, and overall survival.
The study also checks safety and how well you tolerate the medicine, which means whether side effects occur and how serious they are.
Step 4
Study end assessment
At the end of the study period, your response to telisotuzumab adizutecan and any side effects are assessed as part of the trial.
The study is planned to run from 2026-06-15 to 2030-12-14.

Who can join the trial?

7 criteria

Have a locally advanced or metastatic solid tumor, meaning a solid cancer that has grown beyond its original place or has spread to other parts of the body.
Have MET amplification shown on testing, confirmed by either local next-generation sequencing (NGS) or central NGS using the FoundationOne Companion Diagnostic (F1CDx). NGS is a type of DNA test used to look for changes in cancer genes.
Have a measurable disease at the start of the study, meaning the tumor can be seen and measured on scans or other accepted tests, using RECIST 1.1 or RANO criteria as appropriate for the tumor type. RECIST and RANO are standard ways to measure tumor size and change over time.
Have already received prior systemic therapy that was appropriate for the type and stage of cancer. Systemic therapy means treatment that travels through the body, such as chemotherapy or targeted therapy.
Have no satisfactory alternative treatment available that would be expected to give a meaningful survival benefit for the cancer type.
If there are central nervous system (CNS) metastases , they must be either clinically asymptomatic or radiologically stable. CNS means the brain and spinal cord. Clinically asymptomatic means causing no symptoms. Radiologically stable means scans show no worsening after definitive treatment.
Have a general physical condition that allows daily activity with little or no help, with an ECOG Performance Status of 0 to 1. ECOG is a scale doctors use to describe how well a person can carry out normal activities; 0 means fully active, and 1 means some symptoms but still able to do light work.

Who cannot join the trial?

3 criteria

Any current, past, or suspected interstitial lung disease (a long-term lung condition that causes scarring or inflammation in the lungs) or pneumonitis (inflammation of the lung tissue) that needed treatment with steroids (medicine that reduces inflammation).
Any major or life-threatening medical condition that would make it unsafe to take part in the study.
Not expected to live for at least 12 weeks.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Centre Leon Berard
Verified
Lyon, France
Hospital General Universitario Gregorio Maranon
Verified
Madrid, Spain
Hospital Universitario 12 De Octubre
Verified
Madrid, Spain

Trial locations

Where you can join this trial

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Investigated drugs

Telisotuzumab adizutecan is the study medicine being tested in this trial. It is given through a vein as an infusion. The trial is checking whether this medicine can help shrink or control locally advanced or metastatic solid tumors that have MET amplification. It is also being studied to see how safe it is and how well people can tolerate it when used on its own.

What is already known about the treatment

Telisotuzumab adizutecan - Telisotuzumab adizutecan is given by intravenous infusion, which means it is delivered slowly into a vein by a healthcare professional in a clinic or hospital. It is an investigational medicine, so it is still being studied and is not yet a standard treatment in routine medical care. It is designed to treat some advanced solid tumors, especially cancers with MET amplification, by using a targeted antibody to find the MET protein on cancer cells and a linked cancer-killing drug to damage those cells from the inside. It belongs to a group of targeted cancer medicines called antibody-drug conjugates.

Investigated diseases

Locally Advanced or Metastatic Solid Tumors - These are solid cancers that have grown beyond their original site or have spread to other parts of the body. They usually develop as the tumor cells continue to divide and invade nearby tissue, and later may spread through the blood or lymph system to distant organs. As the disease advances, the tumor burden often increases and can affect the function of the organs involved.