Not recruiting

Study on ANV600 and Pembrolizumab for Patients with Advanced Solid Tumors

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 effects of a new treatment for people with advanced solid tumors. These are types of cancer that have spread and are not easily removed by surgery. The study will test a new medication called ANV600, which is a liquid form of treatment, both on its own and in combination with another medication called pembrolizumab, also known as Keytruda. Pembrolizumab is already used to treat certain types of cancer by helping the immune system fight cancer cells.

The purpose of this study is to evaluate the safety and effectiveness of ANV600, both by itself and when used with pembrolizumab, in treating advanced solid tumors. Participants in the study will receive these treatments through an infusion, which means the medication is given directly into the bloodstream. The study will be conducted in two phases. In the first phase, researchers will determine the best dose of ANV600 that can be safely given to patients. In the second phase, they will assess how well the treatment works in reducing the size of tumors.

Throughout the study, participants will be closely monitored for any side effects or reactions to the treatment. The study aims to find out how long the treatment can keep the cancer from getting worse and how long patients can live after receiving the treatment. This research is important for developing new ways to treat advanced cancers and improve the quality of life for patients with these conditions.

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
Joining the study
Upon joining the study, the participant provides written informed consent. This is a document that confirms understanding of the study and agreement to participate.
Eligibility is confirmed based on criteria such as age, health status, and ability to comply with the study protocol.
Step 2
Phase I: dose escalation
The initial phase involves determining the maximum tolerated dose of ANV600 alone and in combination with pembrolizumab. This is done by gradually increasing the dose until side effects become too severe.
Participants receive ANV600 and pembrolizumab as a liquid solution through an infusion, which is a method of delivering medication directly into the bloodstream.
Step 3
Phase I: monitoring
During this phase, the frequency and severity of any side effects are closely monitored. This helps to understand how the body reacts to the treatment.
Blood samples may be taken to measure the levels of ANV600 in the body and to check for any immune reactions.
Step 4
Phase II: treatment
In this phase, the focus is on assessing the effectiveness of ANV600 alone and in combination with pembrolizumab in treating advanced solid tumors.
Participants continue to receive the medication through infusion, and the response to the treatment is evaluated using imaging techniques.
Step 5
Phase II: evaluation
The response to the treatment is measured by the reduction in tumor size and the duration of this response.
Additional assessments include progression-free survival, which is the length of time during and after treatment that the disease does not worsen, and overall survival, which is the length of time from the start of treatment that participants are still alive.
Step 6
End of study
The study is estimated to conclude by October 31, 2027. At this point, all data collected will be analyzed to determine the overall safety and effectiveness of the treatment.

Who can join the trial?

11 criteria

The participant, or their legally acceptable representative, must provide written informed consent to join the trial.
The participant should have a life expectancy of at least 3 months.
The participant must be able to follow the study rules as determined by the study doctor.
The participant must be 18 years of age or older on the day they sign the informed consent.
The participant should have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, which is a scale used to assess how a disease affects a patient's daily living abilities.
The participant must have a measurable disease according to RECIST v1.1, a set of rules used to measure how tumors respond to treatment. If the disease is in an area that was previously treated with radiation, it must show signs of getting worse to be considered measurable.
For Phase I: Participants should have advanced solid tumors that cannot be removed by surgery or have spread to other parts of the body, and there are no standard treatments available, or they cannot tolerate such treatments. For Phase II: Additional specific criteria will apply.
The participant must have adequate organ function as defined in the study protocol.
Women who can have children must have a negative pregnancy test within 7 days before the first dose of the study treatment and must be less than 12 months after menopause.
Female participants who are not postmenopausal and have not had surgery to prevent pregnancy must agree to use highly effective birth control methods during the treatment and for 6 months after the last dose. They must also agree not to donate eggs during this time.
Male participants with partners who can have children must agree to use highly effective birth control methods and a condom during the treatment and for 6 months after the last dose. They must also agree not to donate sperm during this time.

Who cannot join the trial?

10 criteria

Patients who have not been diagnosed with advanced solid tumors. This means the study is only for those with a specific type of cancer that has spread or grown significantly.
Patients who are not within the specified age range for the study. The study has specific age requirements that participants must meet.
Patients who are not able to follow the study procedures or take the study medication as required.
Patients who are pregnant or breastfeeding, as the study may involve medications that could affect the baby.
Patients who have other medical conditions that could interfere with the study or make participation unsafe.
Patients who are currently participating in another clinical trial or have recently participated in one, as this could affect the study results.
Patients who have allergies or reactions to the study medications or similar drugs.
Patients who have a history of certain heart conditions, as these could be worsened by the study medications.
Patients who have an active infection or other serious illness that could interfere with the study.
Patients who have a history of drug or alcohol abuse, as this could affect their ability to participate in the study.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Responsive
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
Responsive
Hospital Universitario Hm Sanchinarro
Madrid, Spain
Responsive
Institut De Cancerologie De Lorraine
Vandoeuvre Les Nancy, France

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

ANV600
is a new medication being tested for its ability to treat advanced solid tumors. In this clinical trial, researchers are trying to find out the highest dose of ANV600 that can be given safely to patients, as well as how effective it is at shrinking tumors when used alone.
Pembrolizumab
is a medication that helps the immune system fight cancer. It is already used to treat various types of cancer. In this trial, pembrolizumab is being combined with ANV600 to see if the combination works better at treating advanced solid tumors than ANV600 alone.

What is already known about the treatment

ANV600 – ANV600 is administered intravenously, meaning it is given directly into a vein. It is currently being studied in clinical trials for its potential use in treating advanced solid tumors. The main therapeutic indication for ANV600 is its use as a treatment for these types of cancers, either alone or in combination with another medication called pembrolizumab. At the molecular level, ANV600 works by targeting specific pathways that are involved in tumor growth and survival, helping to inhibit the progression of cancer cells. It is classified pharmacologically as an anti-cancer agent, specifically designed to interfere with cancer cell mechanisms.

Investigated diseases

Advanced Solid Tumors – These are a group of cancers that originate in solid organs or tissues, such as the breast, lung, or colon, and have progressed to an advanced stage. They are characterized by the uncontrolled growth of abnormal cells that form a mass or lump. As the disease progresses, these tumors can invade nearby tissues and spread to other parts of the body through the bloodstream or lymphatic system. Symptoms vary depending on the location and size of the tumor but may include pain, swelling, or dysfunction of the affected organ. The progression of advanced solid tumors can lead to significant changes in the body's normal functions. The disease's impact on the body can vary widely, depending on the tumor's location and the extent of its spread.