Not recruiting

A study to evaluate the safety and effectiveness of KD033 in 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 study focuses on individuals with Cancer, specifically those with solid tumors that are either locally advanced, meaning they have grown into nearby tissues, or metastatic, which means the cancer has spread to other parts of the body. The investigation aims to evaluate the safety and effectiveness of an experimental medication called KD033, also known as SAR445710. This medication is administered as a solution for injection directly into a vein, a process known as intravenous administration.

The purpose of this study is to determine how much of the drug can be safely given and to observe how the body processes it. During the first part of the study, different groups of participants will receive increasing amounts of KD033 to find the maximum dose that can be tolerated without causing severe side effects. This involves monitoring for dose limiting toxicities, which are harmful side effects that prevent further increases in the amount of medicine given. The study also looks at pharmacokinetics, which describes how the drug moves through the body, and pharmacodynamics, which refers to the drug's effects on the body.

Following the initial dose adjustments, an expansion phase will occur to further observe the safety and early signs of how well the medication works. Throughout the process, researchers will monitor adverse events, which are any unexpected or unpleasant medical occurrences that happen during the treatment. The study also tracks the best overall response to see if the tumors shrink or stabilize in size after receiving the medication.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Administration of medication
The medication kd033 is administered through an intravenous injection, which means it is delivered directly into a vein.
The dose is 400.0 µg/kg (micrograms per kilogram of body weight) as a solution for injection.
The medication is given as a monotherapy, meaning it is the only treatment being tested during this stage.
Step 2
Dose escalation phase
The medication is administered in different amounts to determine the maximum tolerated dose, which is the highest amount of medicine that can be given without causing unacceptable side effects.
Dosing occurs in different groups, following either bi-weekly (every two weeks) or weekly schedules.
Step 3
Expansion cohort phase
The expansion cohort stage follows the initial phase to further confirm how safe and well-tolerated the kd033 medication is.
This phase also looks for early signs of how effective the treatment may be against solid tumors (types of cancer that form a solid mass of cells).
Step 4
Monitoring and evaluation
Safety is monitored by tracking dose limiting toxicities, which are side effects serious enough to prevent an increase in the medication dose.
adverse events, which are any side effects or medical problems occurring during the study, are recorded and categorized by their severity.
The response to the treatment is evaluated to see if the tumor size changes or if the effect lasts over time.
blood samples are collected to study how the medication moves through the body and to check for the development of antibodies, which are proteins the body produces in response to the medication.

Who can join the trial?

10 criteria

You must have a confirmed advanced or metastatic solid tumor, which means a type of cancer that has grown or spread to other parts of the body, and at least one part of the tumor must be in a location where a doctor can perform a biopsy (taking a small sample of tissue for testing).
You must be able to understand why the study is being done and sign a consent form, which is a document that explains the study details and your agreement to join.
You must be willing to have a tumor biopsy (a procedure to take a tissue sample) before starting the treatment and again at the start of the fourth treatment cycle.
Your cancer must be measurable, meaning it is large enough or clear enough to be tracked using standard medical imaging rules.
You must have a life expectancy of at least 3 months.
You must have a good performance status, specifically an ECOG score of 1 or less, which means you are still able to carry out most daily activities and are mostly mobile.
You must have adequate organ and bone marrow function, meaning your vital organs (like the liver and kidneys) and the part of your body that makes blood cells are working well.
Any side effects from previous radiotherapy (radiation treatment), chemotherapy (drug treatment for cancer), or surgery must have mostly recovered, meaning they are either gone or are very mild.
Men and women who may still be able to have children must use highly effective contraception (methods used to prevent pregnancy) during the study and for at least 60 days after the last dose.
Women who are able to become pregnant must have a negative pregnancy test within 7 days before receiving the study medication.

Who cannot join the trial?

22 criteria

You cannot participate if you have used immunotherapy, biological therapy, or cytokine therapy (treatments that use the body's immune system to fight disease) within 21 days before the first dose of the study drug.
You cannot participate if you have a tumor in your central nervous system (the brain or spinal cord) or if the cancer has spread to that area, unless the tumor was previously treated, has not grown for at least 1 month, you have no symptoms, and you have not needed steroids (anti-inflammatory medicines) or enzyme inducing anticonvulsants (medicines used to prevent seizures that can affect how other drugs work) in the last 14 days.
You cannot participate if you have received an organ transplant or a hematopoietic cell transplantation (a transplant of blood-forming stem cells, such as bone marrow).
You cannot participate if you have a paraneoplastic syndrome of an autoimmune nature (a condition where the immune system mistakenly attacks the body's own healthy cells, triggered by a cancer).
You cannot participate if you have a history of interstitial lung disease (scarring or inflammation of the lung tissue) or severe obstructive pulmonary disease (conditions that make it difficult to breathe due to blocked airways).
You cannot participate if you have significant cardiovascular disease (heart problems) or cerebrovascular disease (problems with blood vessels in the brain, such as a stroke).
You cannot participate if your QTc interval (a measurement of the time it takes for your heart muscle to recharge between beats) is longer than 450 milliseconds for men or 470 milliseconds for women.
You cannot participate if your left ventricular ejection fraction (a measurement of how much blood your heart's main pumping chamber pushes out with each beat) is less than 50% as shown on an echocardiogram (an ultrasound of the heart).
You cannot participate if you have an active infection that requires medical treatment.
You cannot participate if you have other diseases, metabolic dysfunction (problems with how your body turns food into energy), or unusual results from a physical exam or laboratory tests.
You cannot participate if you are pregnant or breastfeeding.
You cannot participate if you have used immunomodulating agents (medicines that change the way the immune system works) within 21 days before the first dose.
You cannot participate if you have a known severe hypersensitivity reaction (an extreme allergic reaction) to monoclonal antibodies (laboratory-made proteins that target specific parts of the immune system) or if you have had anaphylaxis (a life-threatening allergic reaction) within the last 6 months.
You cannot participate if you have received a vaccine within 4 weeks of starting the study drug.
You cannot participate if you receive live vaccines (vaccines that use a weakened form of a germ) while participating in the trial.
You cannot participate if you have used chemotherapy or tyrosine kinase inhibitor (TKI) therapy (a type of targeted drug that blocks signals for cancer cells to grow) within 14 days before the first dose.
You cannot participate if you have used anti PD-L1 or anti PD-1 therapy (specific types of immunotherapy) within 6 weeks before the first dose.
You cannot participate if you have had radiotherapy (treatment using radiation to kill cancer cells) within 14 days before starting the trial, unless it was palliative radiation (radiation used to relieve pain or symptoms rather than to cure the disease) that meets specific safety criteria.
You cannot participate if you have used any investigational drug (a drug being tested in studies) or had major surgery within 28 days before starting the treatment.
You cannot participate if you have ongoing or recent evidence of a significant autoimmune disease (where the immune system attacks healthy cells) that required systemic immunosuppressive treatments (medicines that lower the body's overall immune response) within the last 2 years.
You cannot participate if you have used immunosuppressive agents, including corticosteroids (strong anti-inflammatory medicines), within 14 days before the treatment, unless you are using them to replace hormones due to adrenal insufficiency (when the adrenal glands do not produce enough hormones).
You cannot participate if your disease is rapidly progressive (growing or spreading very quickly) in a way that may make it difficult for you to tolerate the treatment or the study procedures.

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Verified sites

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

Verified
Assistance Publique Hopitaux De Marseille
Marseille, France
Verified
Assistance Publique Hopitaux De Paris
Paris, France
Responsive
Hospital Universitario Hm Sanchinarro
Madrid, Spain

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Investigated drugs

KD033 is an experimental medicine being tested to see if it is safe and if it can help treat people with advanced or spreading solid tumors. It is given directly into a vein through an injection.

What is already known about the treatment

KD033 - This medication is an experimental drug administered through an injection into a vein to treat advanced or spreading solid tumors. Currently being studied in early-stage clinical trials, it belongs to a class of drugs designed to target specific proteins found on the surface of cancer cells. At a molecular level, it works by attaching itself to these targets to help the body's immune system recognize and attack the cancer.

Investigated diseases

Cancer - This condition occurs when abnormal cells grow uncontrollably and spread to other parts of the body. These cells can form masses known as tumors in various organs or tissues. As the condition progresses, the abnormal cells may invade nearby healthy structures and disrupt normal bodily functions. The process can involve cells traveling through the blood or lymphatic system to reach distant sites. This uncontrolled growth can occur in many different types of solid tissues throughout the body.