Study of BT8009 and Pembrolizumab for Patients with Advanced Cancers Expressing Nectin-4

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What is this study about?

This clinical trial is focused on studying advanced cancers that express a protein called Nectin-4. The study is investigating a new treatment called BT8009, which is given as a solution through an intravenous infusion. In some parts of the study, BT8009 is used alone, while in others, it is combined with another medication called Pembrolizumab. The purpose of the study is to assess the safety and initial effectiveness of BT8009 in patients with these types of cancers.

Participants in the study will receive the treatment over a period of time, and researchers will monitor them to see how their bodies respond. The study will look at how well the treatment is tolerated and how it affects the cancer. Some patients will receive BT8009 by itself, while others will receive it in combination with Pembrolizumab. The study will also include patients with different levels of kidney function to understand how the treatment works in these conditions.

The study aims to find the most suitable dose of BT8009 and to gather information on how the drug moves through the body. Researchers will also evaluate the overall response of the cancer to the treatment. This information will help determine if BT8009 could be a potential treatment option for patients with advanced cancers that express Nectin-4.

1 joining the study

Upon joining the study, informed consent is required. This involves signing a document that confirms understanding of the study and agreement to participate.

Eligibility is confirmed based on criteria such as age, health status, and specific medical conditions.

2 initial assessment

An initial assessment is conducted to evaluate health status. This includes physical examinations, blood tests, and imaging studies.

The purpose is to establish a baseline for monitoring changes during the study.

3 treatment phase

The treatment involves the administration of BT8009 and pembrolizumab through intravenous infusion.

The dosage and frequency depend on the specific cohort within the study. For example, BT8009 may be administered as monotherapy or in combination with pembrolizumab.

4 monitoring and follow-up

Regular monitoring is conducted to assess the safety and effectiveness of the treatment. This includes checking for side effects and measuring the response to treatment.

Follow-up visits are scheduled to track progress and make any necessary adjustments to the treatment plan.

5 completion of study

Upon completion of the study, a final assessment is conducted to evaluate overall health and the outcomes of the treatment.

Participants may be asked to provide feedback on their experience during the study.

Who Can Join the Study?

The patient must provide a signed and dated written consent form before any study-related procedures, tests, or analyses are done.
The patient must be at least 18 years old at the time of signing the consent form.
The patient should have an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1, which means they are fully active or have some restrictions but can still do light work. Patients with certain types of cancer may have a score of 2, which means they are capable of all self-care but unable to carry out any work activities.
The patient must have a measurable disease according to specific criteria used to evaluate tumors. This means the disease can be measured and tracked over time.
The patient must have acceptable organ function, which includes:
- Good kidney function, shown by a creatinine clearance of at least 50 mL/min.
- Normal levels of bilirubin, a substance made by the liver, unless they have a specific condition called Gilbert syndrome.
- Serum albumin, a protein in the blood, should be at least 2.5 g/dL.
- Normal levels of liver enzymes, unless there are liver metastases, which are cancer spread to the liver.
- A normal blood clotting ability, unless the patient is on stable anticoagulant therapy.
The patient must have acceptable blood function, which means:
- Hemoglobin levels of at least 9 g/dL, which is important for carrying oxygen in the blood.
- An absolute neutrophil count (ANC) of at least 1500 cells/mm³, which is important for fighting infections.
- A platelet count of at least 75,000 cells/mm³, which is important for blood clotting.
Women who can become pregnant must have a negative pregnancy test before starting the treatment.
The patient must have available tumor samples from previous tests or be willing to provide a new tumor biopsy during the screening process.
The patient must have a life expectancy of at least 12 weeks after starting the treatment, as judged by the doctor.
The patient must be willing and able to follow the study’s rules, including attending scheduled visits, following the treatment plan, and undergoing tests and procedures.
Additional specific criteria may apply depending on the group or part of the study the patient is in.

Who Cannot Join the Study?

Patients who have a different type of cancer that does not express Nectin-4. Nectin-4 is a protein that can be found on the surface of some cancer cells.
Patients who have not been exposed to EV (enfortumab vedotin) if they are in certain groups of the study. EV is a type of cancer treatment.
Patients who are eligible for cisplatin treatment if they are in certain groups of the study. Cisplatin is a common chemotherapy drug.
Patients who do not have moderate to severe renal insufficiency if they are in the specific group studying this condition. Renal insufficiency means the kidneys are not working as well as they should.
Patients who do not have urothelial carcinoma if they are in the specific group studying this type of cancer. Urothelial carcinoma is a cancer that occurs in the urinary system.
Patients who do not have ovarian cancer, triple-negative breast cancer (TNBC), or non-small cell lung cancer (NSCLC) if they are in the specific groups studying these cancers.
Patients who are not able to follow the study’s treatment schedule, which includes specific days for receiving the medication.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France

Other Sites

Site Name	City	Country
Ospedale San Raffaele S.r.l.	Milan	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Ctunza Lpic Bxekkw	Lyon	France
Hcctlzkv Uhgnvesogwitn Mucfuwc Dp Vfaphpckgr	Santander	Spain
Flzgpslld Ppwa La Iufhafsuyyyqk Bvqmiczxt Dcj Hptbqman Udpefjlirnsvl Lp Puf	Madrid	Spain
Hcpnjxdu Vsdn dqfhnupc	Barcelona	Spain
Inrexfkm Pflbofwkbthiqeu Cpsfof Cqjbci	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.07.2020
Italy	Not recruiting	01.07.2020
Spain	Not recruiting	01.07.2020

Trial locations

Investigated drugs:

BT8009 (Zelenectide Pevedotin) is an investigational medication being studied for its safety and effectiveness in treating advanced cancers that express a protein called Nectin-4. It is being tested both as a standalone treatment and in combination with another medication. The study aims to understand how well this medication works in shrinking tumors and how the body processes it.

Pembrolizumab is a medication used in combination with BT8009 in this study. It is an immunotherapy drug that helps the immune system recognize and attack cancer cells. The combination is being tested to see if it improves treatment outcomes for patients with certain types of cancer.

Advanced Solid Tumor Malignancies – These are cancers that have spread beyond their original site and are characterized by uncontrolled cell growth. They can occur in various organs and tissues, leading to a range of symptoms depending on the location and size of the tumor. As the disease progresses, it may invade nearby tissues and organs, potentially causing pain and dysfunction. The tumors can also metastasize, meaning they spread to distant parts of the body, complicating treatment and management. The progression of these malignancies can vary widely, influenced by factors such as the type of cancer and the patient’s overall health.

Urothelial Carcinoma – This is a type of cancer that typically begins in the cells lining the bladder, but it can also occur in other parts of the urinary tract. It is characterized by the abnormal growth of urothelial cells, which can form tumors. As the disease advances, it may invade deeper layers of the bladder wall and spread to nearby lymph nodes and other organs. Symptoms often include blood in the urine, frequent urination, and pain during urination. The progression of urothelial carcinoma can lead to more severe symptoms and complications if it spreads beyond the urinary tract.

Ovarian Cancer – This cancer originates in the ovaries and is known for its subtle symptoms in the early stages, such as bloating, pelvic pain, and changes in bowel habits. As it progresses, the cancer can spread to the pelvis and abdomen, leading to more pronounced symptoms and complications. The disease often goes undetected until it has advanced, making it more challenging to manage. The progression involves the growth and spread of cancerous cells, which can affect the function of nearby organs.

Triple-Negative Breast Cancer (TNBC) – This is a subtype of breast cancer that lacks the three most common types of receptors known to fuel most breast cancer growth. It is characterized by its aggressive nature and tendency to spread more quickly than other types of breast cancer. TNBC can be more challenging to treat due to the absence of targeted receptors. As the disease progresses, it may spread to other parts of the body, leading to more complex symptoms and treatment challenges. The progression can vary, but it often requires a comprehensive approach to management.

Non-Small Cell Lung Cancer (NSCLC) – This is the most common type of lung cancer, accounting for a majority of cases. It begins in the tissues of the lungs and can grow and spread to other parts of the body. Symptoms may include a persistent cough, chest pain, and shortness of breath. As NSCLC progresses, it can invade nearby tissues and organs, leading to more severe symptoms and complications. The disease’s progression is influenced by factors such as the stage at diagnosis and the patient’s overall health.

Trial ID:

2023-509781-37-00

Protocol code:

BT8009-100

NCT ID:

NCT04561362

Trial Phase:

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

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Study of BT8009 and Pembrolizumab for Patients with Advanced Cancers Expressing Nectin-4

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?