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Study on the Safety of Tiragolumab and Atezolizumab for Patients with Advanced or Metastatic Solid Tumors

Fast replyInvestigationalNo 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 the safety and behavior of a new treatment for people with certain types of cancer known as solid tumors. These tumors can be locally advanced, which means they have grown but not spread far, or they can be recurrent, meaning they have come back after treatment, or metastatic, which means they have spread to other parts of the body. The treatment being tested is a combination of two medications, atezolizumab and tiragolumab, given together as a solution through an intravenous infusion, which is a way to deliver medicine directly into the bloodstream.

The purpose of this study is to evaluate how safe this combination treatment is and how it behaves in the body. Participants will receive the treatment and be monitored for any side effects or reactions. The study will also look at how the body processes the medications, including how much of the drug is present in the blood at different times. This will help researchers understand the treatment's safety and how it might work in treating solid tumors.

Throughout the study, participants will receive regular check-ups and tests to monitor their health and the effects of the treatment. The study aims to gather important information that could lead to new treatment options for people with solid tumors. The trial is expected to continue until late 2025, providing valuable insights into the potential benefits and risks of this new treatment combination.

The research process

The trial runs in 5 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, participation is confirmed for individuals with specific types of solid tumors that are locally advanced, recurrent, or metastatic.
Eligibility requires a life expectancy of at least 12 weeks and measurable disease according to specific criteria.
Step 2
Treatment administration
The treatment involves a combination of two medications: tiragolumab and atezolizumab.
These medications are administered as a fixed-dose combination through an intravenous infusion.
The solution is prepared for infusion and given to the patient at specified intervals.
Step 3
Monitoring and evaluation
Throughout the study, the safety and tolerability of the treatment are closely monitored.
The primary focus is on the incidence and severity of any adverse events experienced during the trial.
Blood samples are taken to measure the concentration of the medications in the body at different times, particularly during the first cycle of treatment.
Step 4
Antibody assessment
The presence of anti-drug antibodies (ADAs) is assessed at the beginning of the study and monitored throughout.
This helps to understand if the body is developing any resistance to the medications.
Step 5
Completion of the study
The study is expected to continue until December 26, 2025.
Participants will be informed about the outcomes and any further steps after the study concludes.

Who can join the trial?

7 criteria

The patient must have a type of cancer called a solid tumor, which means the cancer forms a mass or lump in the body.
The patient must have a confirmed diagnosis of cancer that is either locally advanced (spread to nearby areas), recurrent (come back after treatment), or metastatic (spread to other parts of the body) and cannot be treated with standard local treatments.
The patient must have adequate hematologic and end organ function, meaning their blood and major organs are working well enough to participate in the study.
The patient's tumor must be PD-L1-selected, which means it has a specific protein that can be identified by a special test called the VENTANA® PD-L1 (SP263) IHC assay. The types of tumors include esophageal adenocarcinoma (EAC), esophageal squamous cell carcinoma (ESCC), gastric cancer (GC), gastroesophageal junction cancer (GEJ), hepatocellular carcinoma (HCC), melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), squamous cell carcinoma of the head and neck (SCCHN), and urothelial bladder cancer (UBC).
The patient must have a measurable disease according to a standard called RECIST v1.1, which means the cancer can be measured in size to see if it changes during the study.
The patient must have a life expectancy of at least 12 weeks, meaning they are expected to live for at least 12 more weeks.
The patient must be within the age range of adults, which includes both male and female participants.

Who cannot join the trial?

4 criteria

Patients who have a type of cancer that is not a solid tumor. A solid tumor is a mass of tissue that does not contain liquid areas or cysts.
Patients who are not within the specified age range for the study. The study is open to certain age groups only.
Patients who are not able to receive the study medications safely. This means the doctors believe the treatment might not be safe for them.
Patients who are part of a vulnerable population that the study cannot safely include. Vulnerable populations may include groups like pregnant women or people with certain disabilities.

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Verified sites

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

Alexandra Hospital
Verified
Athens, Greece
Hospital Universitario Hm Sanchinarro
Responsive
Madrid, Spain
KBC Zagreb
Responsive
Zagreb, Croatia

Trial locations

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Investigated drugs

Tiragolumab
is a medication being studied for its potential to help the immune system fight cancer. It works by blocking a specific protein that can prevent the immune system from attacking cancer cells. In this trial, it is being tested in combination with another medication to see if it can improve treatment outcomes for patients with advanced or recurrent solid tumors.
Atezolizumab
is an immunotherapy drug that helps the body's immune system recognize and attack cancer cells. It targets a protein that can hide cancer cells from the immune system. In this study, atezolizumab is combined with tiragolumab to evaluate if the combination is safe and effective for treating patients with certain types of advanced cancer.

What is already known about the treatment

Tiragolumab
This medication is administered intravenously and is currently being studied in clinical trials for its safety and effectiveness. It is primarily used for treating solid tumors, which are abnormal masses of tissue that can be cancerous. Tiragolumab works by targeting specific proteins on the surface of immune cells, helping the body's immune system to better recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor, a type of drug that helps to boost the immune response against cancer.
Atezolizumab
This medication is also given intravenously and is being evaluated in combination with tiragolumab for its safety and pharmacokinetics. It is used to treat solid tumors, which include various types of cancerous growths. Atezolizumab functions by blocking a protein that prevents the immune system from attacking cancer cells, thereby enhancing the body's natural defenses. It belongs to the class of drugs known as immune checkpoint inhibitors, which are designed to improve the immune system's ability to fight cancer.

Investigated diseases

Solid Tumors – Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in various parts of the body, including organs and bones. These tumors are characterized by the uncontrolled growth of cells that form a lump or mass. As they grow, they may press on nearby structures, potentially affecting their function. Solid tumors can be benign, meaning they do not spread to other parts of the body, or malignant, which means they have the potential to invade nearby tissues and spread to distant sites. The progression of solid tumors depends on their type, location, and growth rate.