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Study of BLU-451 for Patients with Advanced Cancers Having EGFR Exon20 Insertion Mutations

Verified siteInvestigational

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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 certain types of advanced cancers that have specific changes in a gene called EGFR. These changes are known as EGFR exon20 insertion mutations. The trial is testing a new treatment called BLU-451, which is taken as a film-coated tablet. The purpose of the study is to find out how safe and effective BLU-451 is when used alone or in combination with other treatments, such as platinum-based chemotherapy.

The study is divided into two phases. In the first phase, researchers aim to determine the best dose of BLU-451 that can be given safely to patients. They will also look at how well patients tolerate the treatment. In the second phase, the focus will be on how well BLU-451 works against the cancer. Participants will receive either BLU-451 or a placebo, and their health will be monitored closely throughout the study.

During the trial, participants will take the medication orally and will have regular check-ups to assess their response to the treatment. The study will also gather information on any side effects experienced by participants. The trial is expected to continue until July 2026, with recruitment starting in February 2024.

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 based on specific criteria, including a documented mutation in the EGFR gene. This is determined through a test called Next-generation sequencing (NGS), which analyzes a sample from a tumor or a blood test.
A sample of the tumor, either new or previously collected, is required. If previous treatment targeting EGFR was received, a new sample may be needed unless it is unsafe or not possible to obtain.
Step 2
Phase 1 treatment
In Phase 1, the focus is on determining the safest and most effective dose of the medication BLU-451. This involves taking BLU-451 as a film-coated tablet by mouth.
The goal is to find the maximum dose that can be tolerated without severe side effects. This phase also assesses the overall safety of the medication when used alone or with chemotherapy.
Step 3
Phase 2 treatment
Phase 2 evaluates how well BLU-451 works against the cancer. The dose determined in Phase 1 is used to see its effect on tumor size and progression.
Participants must have measurable disease to continue in this phase, which means the cancer can be measured and tracked over time.
Step 4
Monitoring and assessments
Throughout the study, regular monitoring is conducted to assess the safety and effectiveness of the treatment. This includes checking vital signs, conducting electrocardiograms, and performing laboratory tests.
The study also tracks any side effects experienced, their severity, and their relation to the medication.
Step 5
Completion of the study
The study is expected to conclude by July 2026. At the end of the study, the collected data will help determine the overall benefits and risks of BLU-451 for treating advanced cancers with specific genetic mutations.

Who can join the trial?

10 criteria

Must have a documented **EGFR mutation**. This is a specific change in a gene that can be found through a test called **Next-generation sequencing (NGS)**, which analyzes a sample from a tumor or blood.
Must be able to provide a new or previously collected tumor sample. This sample should be prepared in a special way called **formalin-fixed, paraffin-embedded (FFPE)**. If you have had a specific type of therapy targeting EGFR after your last sample was taken, a new sample should be provided unless it is unsafe or not possible.
Must have a **performance status** of 0 or 1 according to the **Eastern Cooperative Oncology Group (ECOG)**. This is a scale that measures how well you can perform daily activities.
Must not have had seizures for at least 14 days before joining the study. If you are taking medication to prevent seizures, the dose must be stable for at least 14 days before joining.
Must have adequate **blood, kidney, and liver function**. This means your body is working well enough to handle the treatment.
For Phase 1 participants: Must have a confirmed diagnosis of **metastatic NSCLC** (a type of lung cancer that has spread) or other metastatic cancers, except for primary brain tumors.
For Phase 1 participants: Must have disease that can be measured or evaluated using a method called **RECIST v1.1**.
For Phase 1 participants: Must have experienced disease progression or intolerance to the most recent treatment.
For Phase 2 participants: Must have a confirmed diagnosis of **metastatic NSCLC**.
For Phase 2 participants: Must have disease that can be measured using **RECIST 1.1**.

Who cannot join the trial?

5 criteria

Patients who have not been diagnosed with advanced cancers that have a specific change in their genes called **EGFR Exon20 insertions mutations** cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not part of the specified clinical trial groups cannot participate.
Patients who are not male or female cannot participate.
Patients who are not considered part of a vulnerable population cannot participate.

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Verified sites

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Hospital Universitario 12 De Octubre
Madrid, Spain
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Hospital Universitario da A Coruna
A Coruna Galicia, Spain
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Hospital Vall d’Hebron
Barcelona, Spain

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Investigated drugs

BLU-451
is an investigational medication being studied for its potential to treat advanced cancers with specific genetic mutations known as EGFR exon20 insertion mutations. The trial aims to find the best dose of BLU-451 that can be used safely and effectively, both on its own and when combined with other cancer treatments.
Platinum-based chemotherapy
is a standard cancer treatment that uses drugs containing the metal platinum to kill cancer cells. In this trial, it is being used in combination with BLU-451 to see if the combination is more effective in treating advanced cancers with EGFR exon20 insertion mutations.

Blu-451

What is already known about the treatment

BLU-451 – BLU-451 is administered orally and is currently being studied in clinical trials for its effectiveness in treating advanced cancers with specific genetic mutations known as EGFR Exon20 insertions. This medication is in the early phases of clinical research, focusing on determining the appropriate dosage and assessing its safety and effectiveness. It is primarily indicated for cancers with these specific genetic alterations. BLU-451 works by targeting and inhibiting the activity of the mutated EGFR protein, which is involved in the growth and spread of cancer cells. It is classified as a targeted therapy, aiming to interfere with specific molecular targets associated with cancer.

Investigated diseases

Advanced Cancers with EGFR Exon20 Insertions Mutations – This condition involves a group of cancers characterized by specific genetic mutations in the epidermal growth factor receptor (EGFR) gene, particularly in the Exon20 region. These mutations lead to abnormal cell growth and division, contributing to cancer progression. The disease can affect various organs, with lung cancer being a common type associated with these mutations. As the cancer advances, it may spread to other parts of the body, complicating treatment and management. The progression of the disease is influenced by the specific nature of the genetic mutations and the body's response to them. Understanding these mutations is crucial for developing targeted therapies to manage the disease effectively.