Study on ANV600 and Pembrolizumab for Patients with Advanced Solid Tumors

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Krankenhaus Nordwest GmbH	Frankfurt	Germany
Centre Antoine Lacassagne	Nice	France
Universitair Ziekenhuis Gent	Gent	Belgium
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hospital Hm Nou Delfos	Barcelona	Spain
Netherlands Cancer Institute	Amsterdam	The Netherlands
Cklolepat Utvgwcdnicdsua Snophplwh	Woluwe-Saint-Lambert	Belgium
Anuogppthy Pawrflyj Hdystyqh Dp Mpecygjuh	Marseille	France
Hqgrndck Vabx dyiotvet	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	31.07.2024
France	Not recruiting	31.07.2024
Germany	Not recruiting	31.07.2024
Spain	Not recruiting	31.07.2024
The Netherlands	Not recruiting	31.07.2024

Trial locations

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.

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.

Trial ID:

2023-509633-39-00

Protocol code:

ANV600-001

NCT ID:

NCT06470763

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study on ANV600 and Pembrolizumab for Patients with Advanced Solid Tumors

What is this study about?

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