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Study on APL-101 for Treating Advanced Solid Tumors and Non-Small Cell Lung Cancer with MET Changes in Patients

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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 treatment of certain types of cancer using a medication called APL-101, also known as Bozitinib. The diseases being studied include advanced solid tumors and Non-Small Cell Lung Cancer (NSCLC) that have specific changes in a gene called MET. These changes can include MET Exon 14 skipping mutations, MET amplification, and MET fusion. The study also looks at tumors in the central nervous system (CNS) with MET alterations and other solid tumors with overexpression of HGF and MET. The purpose of the study is to evaluate the safety and effectiveness of APL-101 in treating these conditions.

Participants in the study will receive APL-101 in the form of a capsule taken by mouth. The study will be conducted in two phases. The first phase has already been completed and focused on understanding the safety and how the body processes the drug. The second phase will focus on how well APL-101 works as a treatment on its own for the cancers mentioned, and also as an additional treatment for NSCLC that has developed resistance to other treatments. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of APL-101.

The study will involve regular check-ups and assessments to monitor the participants' health and the effects of the treatment. This includes measuring the size of tumors and checking for any side effects. The goal is to find the best dose of APL-101 and to see how effective it is in treating these specific types of cancer. Participants will be closely monitored throughout the study to ensure their safety and to gather important information about the treatment's impact on their condition.

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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and conducting necessary tests to ensure all criteria are met.
Step 2
Treatment initiation
The treatment involves taking APL-101, which is a capsule for oral use. The specific dosage and frequency will be determined based on individual needs and study requirements.
Step 3
Monitoring and evaluation
Regular monitoring is conducted to assess the safety and effectiveness of the treatment. This includes routine check-ups, blood tests, and imaging studies to track progress and any side effects.
Step 4
Dose adjustment
If necessary, the dosage of APL-101 may be adjusted based on the body's response to the treatment and any side effects experienced.
Step 5
Continuation of treatment
The treatment continues as long as it is deemed beneficial and safe. Regular assessments will determine the ongoing suitability of the treatment.
Step 6
Final evaluation
At the end of the study period, a final evaluation is conducted to assess the overall effectiveness of the treatment and any long-term effects.

Who can join the trial?

16 criteria

Must be able to understand and follow the study procedures, understand the risks, and provide written consent before any study-specific procedure is done.
Must be 18 years of age or older.
For Phase 1, must have a confirmed advanced or spreading solid tumor that cannot be removed by surgery and has not responded to standard treatments, with no more than three previous treatments.
For Phase 2, must fit into one of the specific groups based on the type of cancer and previous treatments.
Must provide a sample of the tumor, either from a previous biopsy or a new one, if safe and possible. If not enough tumor tissue is available, a blood sample may be used if approved.
Can have treated or untreated brain disease that does not cause symptoms.
Must have at least one measurable tumor that can be used to track the response to treatment.
Must have a good performance status, meaning they are able to carry out daily activities with little or no assistance.
Must have acceptable organ function, as shown by specific blood test results.
Must have adequate heart function.
Women who can have children must have a negative pregnancy test and agree to use effective birth control during the study and for a period after the last dose of the study drug.
All participants who can have children must agree to use effective birth control during the study and for a period after the last dose of the study drug.
Must have recovered from any side effects of previous cancer treatments to a mild level, except for hair loss.
Must not have any major surgery planned within 4 weeks of starting the study treatment.
Must be willing and able to participate in all required evaluations and procedures in the study.
Must have an expected survival of at least 3 months from the start of the study treatment.

Who cannot join the trial?

10 criteria

Patients with other types of cancer that are not the specific types being studied.
Patients who have not shown changes in the MET gene, which is a specific part of the cancer cells being targeted in this study.
Patients who are not within the age range specified for the study.
Patients who are not able to follow the study procedures or take the study medication as required.
Patients who have other serious health conditions that might interfere with the study or make it unsafe for them to participate.
Patients who are pregnant or breastfeeding, as the effects of the study medication on unborn babies or infants are not known.
Patients who are currently participating in another clinical trial or have recently participated in one.
Patients who have had a severe allergic reaction to similar medications in the past.
Patients who have not recovered from the side effects of previous cancer treatments.
Patients who have certain infections or diseases that could affect their immune system.

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Verified sites

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

Assistance Publique Hopitaux De Marseille
Verified
Marseille, France
Istituto Europeo Di Oncologia S.r.l.
Responsive
Milan, Italy
Istituto Oncologico Veneto
Responsive
Padua, Italy

Trial locations

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Investigated drugs

APL-101 is an investigational medication being studied for its potential to treat certain types of cancer. It is being tested in patients with non-small cell lung cancer (NSCLC) that have specific genetic changes known as c-Met Exon 14 skip mutations and c-Met dysregulation. The study aims to evaluate the safety, how the body processes the drug, and its preliminary effectiveness. APL-101 is taken orally and is being assessed both as a standalone treatment and in combination with other therapies for various advanced solid tumors, including those with MET amplification, MET fusion, and other MET-related alterations.

Apl-101

What is already known about the treatment

APL-101 – APL-101 is an oral medication currently being studied in clinical trials for its safety, pharmacokinetics, and preliminary efficacy in treating certain types of advanced solid tumors and non-small cell lung cancer (NSCLC) with specific genetic changes known as MET aberrations. It is in the investigational stage, with ongoing research to determine its effectiveness and optimal dosing. The main therapeutic indications include NSCLC with MET exon 14 skipping mutations, MET amplification, and other solid tumors with similar genetic profiles. APL-101 works by targeting and inhibiting the MET protein, which plays a role in cell growth and survival, potentially slowing down or stopping the progression of cancer. It is classified as a targeted therapy, focusing on specific molecular targets associated with cancer.

Investigated diseases

Non-Small Cell Lung Cancer with MET Aberrations
This type of lung cancer is characterized by changes in the MET gene, which can lead to uncontrolled cell growth. The MET gene alterations may include exon 14 skipping mutations, amplifications, or fusions. These genetic changes can cause the cancer cells to grow and spread more rapidly. The disease typically progresses through stages, starting from localized tumors to more advanced stages where the cancer spreads to other parts of the body. Symptoms may include persistent cough, chest pain, and difficulty breathing. The progression and symptoms can vary depending on the specific MET aberration present.
Advanced Solid Tumors with MET Aberrations
These are a group of cancers that originate in solid organs or tissues and have progressed to an advanced stage. The presence of MET gene alterations, such as amplifications or fusions, can drive the growth and spread of these tumors. These genetic changes can lead to increased tumor aggressiveness and resistance to certain treatments. The disease can affect various organs, leading to a range of symptoms depending on the tumor's location. As the tumors grow, they may invade nearby tissues and spread to distant sites. The progression of the disease can vary widely based on the type and location of the tumor.