Recruiting

Study on Atezolizumab, Amivantamab, and Futibatinib for Patients with Advanced Solid Tumors

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This clinical trial is focused on studying advanced solid tumors, which are types of cancer that have spread and are difficult to remove with surgery. The study aims to evaluate the effectiveness of specific treatments for these cancers. The treatments being tested include atezolizumab, known by its code name RO5541267, amivantamab, and futibatinib. These medications are designed to target specific characteristics of the cancer cells.

The purpose of the study is to assess how well these treatments work in small groups of patients who have been selected based on the specific molecular features of their tumors. Participants will receive one of the treatments, which may be given as a solution for infusion, meaning it is administered directly into the bloodstream through a vein, or as a tablet taken by mouth. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the treatments.

The study will be conducted over a period of time, during which participants will be monitored for their response to the treatment. This includes checking for any changes in the size or spread of the tumors and observing any side effects. The goal is to find out if these treatments can help control the cancer and improve the quality of life for patients with advanced solid tumors.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including having an advanced solid tumor that is metastatic or cannot be surgically removed.
Consent is required to participate, and understanding of the study details is necessary.
Step 2
Treatment assignment
Participants are assigned to a treatment based on the molecular profile of their tumor.
The study involves three medications: atezolizumab, amivantamab, and futibatinib.
Step 3
Medication administration
Atezolizumab is administered as a solution for infusion through a vein (intravenous use).
Amivantamab is also given as a solution for infusion through a vein.
Futibatinib is taken orally in the form of film-coated tablets.
Step 4
Treatment duration and frequency
The duration and frequency of each medication depend on the specific module of the study and the participant's response to treatment.
Regular monitoring and assessments are conducted to evaluate the effectiveness of the treatment.
Step 5
Monitoring and assessments
Participants undergo regular health assessments to monitor the response to the treatment.
These assessments include imaging tests and laboratory evaluations to track tumor response and overall health.
Step 6
End of study participation
The study is estimated to conclude by July 19, 2026.
Participants may continue to receive treatment until the study ends or until it is determined that the treatment is no longer beneficial.

Who can join the trial?

13 criteria

Participants must have a confirmed advanced solid tumor that is either spread to other parts of the body (**metastatic**) or cannot be removed by surgery (**unresectable**).
Participants must have tried standard treatments, but these treatments have not worked, or no other approved treatments are available.
Participants must be able to understand and agree to sign a consent form to join the study.
Participants must have proper kidney and liver function. This means certain blood tests must be within specific limits.
Participants taking blood thinners (like heparin or warfarin) should be on a stable dose.
Women who can have children must agree to use birth control or not have heterosexual intercourse during the study.
Men must agree to use birth control or not have heterosexual intercourse and not donate sperm during the study.
Participants must have a good general health status, which is measured by a scale called **ECOG performance status**. They should score 0 or 1, indicating they are fully active or have some restrictions but can still do light work.
Participants must be 18 years old or older.
Participants must have a tumor that can be measured using specific guidelines called **RECIST 1.1**. For prostate cancer, other specific guidelines apply.
Participants must provide enough tumor tissue for analysis. This can be from stored samples or a new biopsy if needed.
Participants must have enough healthy blood cells, including white blood cells and platelets, as shown by blood tests.
Participants must be willing to take part in a study that matches treatment to the specific characteristics of their tumor.

Who cannot join the trial?

5 criteria

Patients who do not have an advanced solid tumor cannot participate. An advanced solid tumor is a type of cancer that forms a mass or lump in the body and has progressed to a more severe stage.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who are not part of the specified clinical trial groups cannot participate. Clinical trial groups are categories of patients based on certain characteristics needed for the study.
Patients who are not willing to follow the study procedures and requirements cannot participate.
Patients who are part of a vulnerable population, such as those who may not be able to give informed consent, cannot participate.

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Verified sites

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

Fondazione I.R.C.C.S. Istituto Neurologico Besta
Verified
Milan, Italy
Hospital Vall d’Hebron
Verified
Barcelona, Spain
Institut Gustave Roussy
Verified
Villejuif, France

Trial locations

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Investigated drugs

Targeted Agents are specialized treatments used in this study to address specific characteristics of advanced solid tumors. These agents are designed to target and interfere with molecules that are involved in the growth, progression, and spread of cancer. By focusing on these specific targets, the therapy aims to reduce the tumor size or slow its growth, providing a more personalized treatment approach for patients with certain molecular profiles.

What is already known about the treatment

Targeted Agent – This medication is administered orally or intravenously, depending on the specific agent being used in the trial. It is currently under investigation in clinical trials for its effectiveness in treating advanced solid tumors. The main therapeutic indication is for patients with these types of tumors, where traditional treatments may not be effective. The medication works by targeting specific molecular pathways that are involved in the growth and spread of cancer cells, thereby inhibiting their progression. It is classified as a targeted therapy, which is a type of cancer treatment that uses drugs to precisely identify and attack cancer cells, usually while doing little damage to normal cells.

Investigated diseases

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. It often progresses slowly and may not show symptoms in the early stages. As it advances, it can cause urinary problems, pelvic discomfort, and bone pain. The disease can spread to nearby tissues or other parts of the body, such as bones and lymph nodes. The progression can vary greatly among individuals, with some experiencing rapid growth and others having a more indolent course.