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A study to evaluate the safety and effectiveness of HLX43 in patients with advanced non-small cell lung cancer

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Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie
Lublin, Poland

What is this trial about?

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

This study focuses on Advanced Non-Small Cell Lung Cancer, which is a common type of lung cancer that has spread or grown significantly. The research aims to evaluate the efficacy and safety of a new treatment called HLX43. This medication is an antibody-drug conjugate, a type of drug designed to deliver a potent medicine directly to cancer cells using a specialized targeting system. The treatment will be given through intravenous administration, meaning it is delivered into a vein using a liquid solution.

The purpose of the study is to determine how well this new drug works and to monitor its safety in people with this condition. During the study, participants will receive the medication, and their health will be closely monitored. This includes checking for any side effects and observing how the cancer responds to the treatment over time.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Medication administration
You will receive the study medication, hlx43, which is an anti-pd-l1 adc. an adc is a type of drug designed to target specific cells.
The hlx43 is provided as a powder for solution for infusion and is administered through an intravenous administration, which means it is delivered directly into a vein.
Step 2
Monitoring and evaluation
During the study, various assessments are conducted to monitor safety and effectiveness.
Monitoring includes laboratory tests, checking vital signs, performing physical examinations, and conducting a 12-lead ecg, which is a test that records the electrical activity of the heart.
The effectiveness of the medication is measured by looking at the objective response rate, which tracks how much the cancer shrinks, and the progression-free survival, which tracks how long the disease stays stable without getting worse.
Assessments are also made regarding overall survival and the duration of response to see how long the treatment effects last.
Blood samples are taken to check blood drug concentration and to look for anti-hlx43 antibodies, which are proteins the body might create in response to the medicine.
Your quality of life is assessed to understand how the treatment affects your daily well-being.

Who can join the trial?

13 criteria

You must be 18 years of age or older at the time you sign the consent form.
You must have advanced non-small cell lung cancer (NSCLC), which is a type of lung cancer that has spread or is more advanced, and it must not be suitable for complete removal by surgery or standard radiation and chemotherapy.
You must have a measurable lesion, which means a tumor that can be clearly seen and measured on medical imaging like a scan, located in an area not previously treated with radiation (unless it is the only option).
You must agree to provide tumor tissue from a previous surgery or biopsy, or undergo a new biopsy (a procedure to take a small sample of tissue) to test for PD-L1 expression (a protein on cancer cells used to help determine treatment).
If you are a person of childbearing age, you must agree to use highly effective contraception (methods to prevent pregnancy) during the study and for at least 8 months after the last dose, and you must have a negative pregnancy test within 7 days before joining.
You must fully understand the study, its processes, and possible adverse reactions (unwanted or harmful side effects), and you must sign the informed consent form (a document that explains the study details before you agree to join).
You must have failed at least one previous standard treatment, which must include platinum-based chemotherapy (a common type of cancer medicine using platinum) and anti-PD-(L)1 antibody (a type of immunotherapy that helps the immune system fight cancer).
Depending on your specific cancer type, you must either have no actionable genomic alterations (specific genetic changes in cancer cells that can be targeted by drugs) or have confirmed actionable genomic alterations that were previously treated with targeted therapy (medicines designed to attack specific parts of cancer cells).
There must be a specific amount of time passed since your last treatments: at least 3 weeks since major surgery, radiation, or chemotherapy; at least 2 weeks since hormone or small molecular targeted therapy; and at least 1 week since traditional Chinese medicine or minor surgery.
Any adverse events (side effects) from previous treatments must have recovered to Grade 1 or less, meaning they are very mild or non-existent.
You must have an ECOG Performance Status of 0 or 1, which is a scale used to measure how well a person can perform daily activities while having a disease.
You must have a life expectancy of more than 3 months.
Your organ functions (how well your organs like the liver or kidneys work) must be healthy according to laboratory tests, and you must not have received blood transfusions or certain blood-boosting medications in the 14 days before the first dose.

Who cannot join the trial?

20 criteria

You cannot participate if your tumor is confirmed to be a different type, such as small cell lung cancer, neuroendocrine carcinoma, or sarcomatoid carcinoma, which are specific ways lung cancer cells can look and behave under a microscope.
You cannot participate if you have an active systemic infection (an infection spreading through your whole body) that required intravenous antibiotics (medicine given directly into a vein) in the last 2 weeks.
You cannot participate if you have used certain liver enzymes inhibitors or inducers (medicines that change how your body processes other drugs) within the last 2 weeks.
You cannot participate if you have used systemic corticosteroids (strong medicines that reduce inflammation and suppress the immune system) or other immunosuppressants (drugs that lower your body's ability to fight infection) in the last 2 weeks, unless they were applied locally like creams or inhaled.
You cannot participate if you have a known active or suspected autoimmune disease (a condition where the immune system mistakenly attacks the body's own healthy cells), though some controlled conditions like certain thyroid issues or type 1 diabetes are allowed.
You cannot participate if you have received a live or live attenuated vaccine (vaccines that use a weakened version of a germ) in the last 4 weeks.
You cannot participate if you have a known allergy or anaphylaxis (a severe, life-threatening allergic reaction) to monoclonal antibodies (lab-made proteins that target specific parts of the immune system) or any part of the study drug.
You cannot participate if you have active tuberculosis (a serious bacterial infection that usually affects the lungs).
You cannot participate if you have a history of immunodeficiency (a weakened immune system), such as HIV, other immune disorders, or a history of organ transplantation.
You cannot participate if you have an active HBV (Hepatitis B) or HCV (Hepatitis C) infection, unless the virus levels are very low and meet specific testing requirements.
You cannot participate if you are pregnant or lactating (breastfeeding).
You cannot participate if you have previously used medicines that target topoisomerase I, which includes certain types of chemotherapy (cancer-fighting drugs) or ADCs (drugs that combine chemotherapy with antibodies to target cancer cells).
You cannot participate if the doctor decides you are not suitable due to other health or laboratory abnormalities (unusual results from blood or urine tests).
You cannot participate if you had radical radiation therapy (intensive radiation treatment to destroy cancer) within the 3 months before your first dose.
You cannot participate if you had a second malignancy (a new, different type of cancer) within the last 2 years, unless it was an early-stage cancer that was fully treated.
You cannot participate if you had to stop immunotherapy (treatment that helps your immune system fight cancer) due to side effects, or if you had pneumonitis (inflammation of lung tissue) or myocarditis (inflammation of the heart muscle) during previous immunotherapy.
You cannot participate if you have uncontrollable fluid buildup in the chest (pleural effusion), around the heart (pericardial effusion), or in the abdomen (ascites) that requires constant draining.
You cannot participate if you have spinal cord compression (pressure on the spinal cord) or metastases (cancer that has spread) to the central nervous system (the brain and spinal cord).
You cannot participate if you have significant pulmonary impairment (lung problems) from conditions like asthma, COPD (chronic obstructive pulmonary disease), interstitial pneumonia (scarring of the lung tissue), or pneumonectomy (surgical removal of a lung).
You cannot participate if you have poorly controlled heart or brain-related issues, such as heart failure, unstable angina (chest pain), myocardial infarction (heart attack), cerebrovascular accident (stroke), arrhythmia (irregular heartbeat), or high hypertension (high blood pressure).

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Verified & featured
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie
Lublin, Poland
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Azienda Ospedaliera Universitaria Senese
Siena, Italy
Responsive
Krakowskie Centrum Medyczne Sp. z o.o.
Cracow, Poland

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Investigated drugs

HLX43 is an experimental drug being tested to see if it can help treat advanced non-small cell lung cancer. It belongs to a class of drugs known as antibody-drug conjugates, which are designed to deliver a powerful medicine directly to cancer cells to help fight the disease.

HLX43

What is already known about the treatment

HLX43 - This medication is an experimental drug delivered as a powder that is mixed into a liquid and administered directly into a vein through an infusion. Currently being studied in clinical trials, it is designed to treat advanced non-small cell lung cancer by acting as an antibody-drug conjugate. It works by targeting and attaching to a specific protein on cancer cells called PD-L1, which then allows the drug to release a powerful medicine directly into the tumor to kill the cancer cells. This drug belongs to a specialized class of targeted therapies known as antibody-drug conjugates.

Investigated diseases

Non-small cell lung cancer - This type of lung cancer begins in the cells that line the airways of the lungs. It is characterized by the uncontrolled growth of abnormal cells that can form tumors. As the disease progresses, these cells may spread from the original site to other parts of the body. The condition often involves different types of cells, such as adenocarcinoma or squamous cell carcinoma. The progression can vary depending on how the cells behave and where they spread.