Study on the Safety and Effects of VERT-002 for Patients with Advanced Solid Tumors, Including Lung Cancer with MET Alterations

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What is this study about?

This clinical trial is focused on studying a new treatment for patients with advanced forms of cancer, specifically those with solid tumors that have spread or are difficult to treat. The study includes patients with non-small cell lung cancer that have specific changes in a gene called MET. The treatment being tested is a new drug called VERT-002, which is given through an infusion into the vein.

The purpose of the study is to learn about the safety and effects of VERT-002 in treating these types of cancers. The study is divided into two parts. In the first part, researchers will determine the safest dose of VERT-002 and how well patients tolerate it. In the second part, they will further explore the drug’s effects and continue to monitor its safety. The study will help identify the best dose to use in future research.

Participants in the study will receive VERT-002 and will be closely monitored by healthcare professionals. The study will look at how the drug affects the cancer and any side effects that may occur. This research is important for developing new treatments for patients with advanced cancers that have limited options. The study is expected to continue for several years to gather comprehensive data on the drug’s effectiveness and safety.

1 joining the trial

Upon joining the trial, eligibility is confirmed based on specific criteria such as the presence of certain genetic changes in the tumor and previous treatments received.

The trial is designed for patients with advanced solid tumors, including lung cancer, with specific genetic changes known as MET alterations.

2 part 1: dose escalation

The initial phase involves determining the safe dosage of the new drug, VERT-002, which is administered through an intravenous infusion.

The focus is on understanding the safety and how well the body tolerates the drug. This involves monitoring for any side effects and adjusting the dose as needed.

3 part 1: safety and tolerability assessment

During this phase, the occurrence and severity of any side effects are closely monitored. This includes changes in laboratory values, physical examinations, and vital signs.

The goal is to identify the optimal dose that can be safely administered without causing significant side effects.

4 part 2a: preliminary activity examination

This phase examines the initial effects of VERT-002 on the tumor, assessing its potential to reduce tumor size or slow its growth.

The drug’s impact on the tumor is evaluated using imaging techniques and other assessments.

5 part 2b: recommended dose determination

The focus is on determining the recommended dose for future studies, based on the safety and effectiveness observed in previous phases.

This involves further monitoring of side effects and the drug’s impact on the tumor.

6 part 2: overall safety and effectiveness

The final phase involves a comprehensive assessment of the drug’s safety and its ability to control the disease.

This includes evaluating the overall response rate, progression-free survival, and overall survival of participants.

Who Can Join the Study?

For Part 1, the patient must have a confirmed diagnosis of a relapsed or resistant locally advanced or metastatic solid tumor for which no standard treatment is available.
The patient must have an albumin level of at least 3 grams per deciliter (g/dL). Albumin is a protein in the blood that helps keep fluid in your bloodstream.
The patient must have adequate cardiac function, meaning their heart is working well enough as defined in the study protocol.
For Part 2, the patient must have a confirmed diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC) at Stage IIIB/C or IV, and they should not be eligible for or should have already received standard treatments like surgery, radiation, or chemotherapy.
For Part 1, the patient must have at least one of the following MET alterations: METex14 mutation, MET kinase domain activating gene mutations, or MET amplification. These are specific changes in the MET gene that can affect cancer growth.
For Part 2-a, the patient must have a METex14 mutation. For Part 2-b, the patient must have at least one of the following MET alterations: METex14 mutation or new MET amplification, confirmed by a tissue sample.
For Part 2, the patient must have at least one measurable target lesion according to RECIST v1.1, which is a set of guidelines to measure how tumors respond to treatment.
The patient must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but can still carry out light work.
For Part 1, the patient may have previously received a MET TKI treatment, which is a type of drug that targets the MET gene, regardless of whether it was their first or second treatment.
For Part 2, the patient can have had up to 3 previous treatments for their advanced or metastatic disease, which may or may not include prior MET TKI treatment.
The patient must have adequate hematologic function before the first dose of VERT-002, meaning their blood cells are functioning well enough as defined by the study’s laboratory tests.
The study is open to both male and female patients.
The study includes patients from vulnerable populations, which means it considers those who might need special protection or care.

Who Cannot Join the Study?

Patients with other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had another cancer treatment recently.
Patients with allergies to the study medication or its ingredients.
Patients who are unable to follow the study procedures.
Patients with certain heart conditions that could be affected by the study medication.
Patients with severe liver or kidney problems.
Patients who have participated in another clinical trial recently.
Patients with infections that are not well controlled.
Patients with a history of drug or alcohol abuse.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Comite Entreprise Paul Papin	Angers	France
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Technische Universitaet Dresden	Dresden	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Institut Curie – Site Paris	Paris	France

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Institut Jules Bordet	Anderlecht	Belgium
Hospital Clinico Universitario De Valencia	Valencia	Spain
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Netherlands Cancer Institute	Amsterdam	The Netherlands
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Hospital Universitario 12 De Octubre	Madrid	Spain
Hcljrgay Urebbxzxmynou Rywggxhf Dc Moookq	Malaga	Spain
Hsxuoyvi Sbc Pbofq	Logrono	Spain
Ivnnyvpd Blkuqgwx	Bordeaux	France
Hgszhuhw Vgmr dyhmkcql	Barcelona	Spain
Udhehshrrv Hdcyuiqj Cosjqjw	Cologne	Germany
Aoqqrdhkpy Pupltlfo Hnreqdaf Dv Mtffsdjhg	Marseille	France
Klmfnnrw dfq Uuvbrcqbgycq Mnvkdpwx Axd	Munich	Germany
Akcjjaj Uccze Siywiagrz Lertfp Dk Bthtutx	Bologna	Italy
Cxgnpq Lugx Bwsauk	Lyon	France
Uvcbealqbm Ov Alywpsq	Edegem	Belgium
Fvtlcwfed Pfoy Lt Iwyrqswhqskms Bidsrendr Dde Hvybeihx Uehlnrvcpgogc Ly Pgq	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	20.01.2025
France	Recruiting	20.01.2025
Germany	Recruiting	20.01.2025
Italy	Recruiting	20.01.2025
Spain	Recruiting	20.01.2025
The Netherlands	Recruiting	20.01.2025

Trial locations

Investigated drugs:

VERT-002

VERT-002 is an investigational medication being studied for its potential to treat patients with advanced or metastatic solid tumors, including non-small cell lung cancer that has specific genetic changes known as MET alterations. The trial aims to understand how safe and tolerable this medication is for patients, as well as to find the best dose that can be used in future studies. Researchers are also looking at how well the medication works in shrinking or controlling the tumors.

Locally Advanced or Metastatic Solid Tumors with MET Alterations – This condition involves solid tumors that have either spread to nearby tissues (locally advanced) or to distant parts of the body (metastatic). These tumors have specific changes in the MET gene, which can affect how the cancer grows and spreads. The progression of the disease can vary, with tumors potentially growing larger or spreading to new areas over time. The MET alterations can influence the behavior of the cancer cells, potentially making them more aggressive. The condition is not classified as a rare disease, indicating it occurs with some frequency in the population. Understanding the specific genetic alterations can be crucial for determining potential treatment approaches.

Trial ID:

2024-512760-64-00

Protocol code:

F60089IV101

NCT ID:

NCT06669117

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study on the Safety and Effects of VERT-002 for Patients with Advanced Solid Tumors, Including Lung Cancer with MET Alterations

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?