Study of BGB-A425, LBL-007, and Tislelizumab for Patients with Advanced Head and Neck Cancer, Lung Cancer, or Kidney Cancer

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What is this study about?

This clinical trial is focused on studying advanced solid tumors, which include types of cancer such as Head and Neck Squamous Cell Cancer, Non-Small Cell Lung Cancer, and Renal Cell Carcinoma. The study is testing the safety and effectiveness of three medications: BGB-A425, LBL-007, and Tislelizumab. These medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to explore how well these medications work together in treating the mentioned cancers. The study is divided into different phases. Initially, the focus is on understanding the safety and how well patients tolerate the combination of BGB-A425 with Tislelizumab. Later, the study will also look at the combination of BGB-A425 and LBL-007 with Tislelizumab, as well as LBL-007 with Tislelizumab. The study aims to find the best dose that patients can handle without severe side effects.

Throughout the study, researchers will monitor patients for any side effects and measure how the cancer responds to the treatment. The study will also assess how the body processes these medications. This research is important for developing new treatment options for patients with these types of advanced cancers.

1 joining the trial

Upon joining the study, participants will be informed about the trial’s purpose, procedures, and potential risks and benefits. Consent will be obtained before any trial-related activities begin.

2 initial assessment

Participants will undergo an initial assessment to confirm eligibility. This includes a review of medical history, a physical examination, and laboratory tests to ensure adequate organ function and overall health status.

3 phase 1: dose escalation

In this phase, participants will receive a combination of BGB-A425 and tislelizumab through intravenous infusion. The goal is to determine the maximum tolerated dose. Participants will be closely monitored for any adverse effects.

4 phase 2: safety lead-in

Participants will receive a combination of BGB-A425, LBL-007, and tislelizumab or LBL-007 with tislelizumab. The focus is on assessing safety and tolerability. Monitoring for adverse effects continues.

5 phase 2: dose expansion

This phase evaluates the antitumor activity of the drug combinations. Participants will receive the recommended doses determined in earlier phases. The objective response rate will be assessed to evaluate the treatment’s effectiveness.

6 ongoing monitoring

Throughout the trial, participants will undergo regular assessments, including physical exams, laboratory tests, and imaging studies, to monitor health status and treatment response. Safety and tolerability will be continuously evaluated.

7 end of trial

Upon completion of the trial, participants will have a final assessment to evaluate overall health and any long-term effects of the treatment. Results will contribute to understanding the treatment’s safety and effectiveness.

Who Can Join the Study?

Must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, which means you should be fully active or have some symptoms but still be able to carry out light work.
Must have adequate organ function, meaning your vital organs like the liver and kidneys are working well enough.
For Phase 1 and Phase 2 Safety Lead-In: Must have advanced, metastatic, or unresectable solid tumors confirmed by tests. You should have already tried standard treatments, or no standard treatment is available or tolerated.
For Phase 2 Dose-Expansion: Must have one of the following confirmed solid tumors:
- For head and neck cancer participants: Recurrent or metastatic head and neck squamous cell cancer that cannot be treated with surgery or radiation with the intent to cure.
- For lung cancer participants: Locally recurrent or advanced non-small cell lung cancer.
- For kidney cancer participants: Locally advanced or metastatic renal cell carcinoma with clear cell type.
Must be within the age range specified for the study.
Both male and female participants are eligible.

Who Cannot Join the Study?

Patients with other types of cancer not listed in the study.
Patients who have not reached the required age range for the study.
Patients who are not able to follow the study procedures or instructions.
Patients who are pregnant or breastfeeding.
Patients with severe or uncontrolled medical conditions that could interfere with the study.
Patients who have had another cancer treatment recently that might affect the study results.
Patients with known allergies to the study drugs or similar medications.
Patients who are participating in another clinical trial at the same time.
Patients with a history of certain heart conditions or diseases.
Patients with active infections that require treatment.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
IRCCS Humanitas Research Hospital	Rozzano	Italy
Hospital Clinico San Carlos	Madrid	Spain
Institut Gustave Roussy	Villejuif	France
Hospital Universitario Hm Sanchinarro	Madrid	Spain

Other Sites

Site Name	City	Country
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Virgen del Rocío University Hospital	Sevilla	Spain
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy	Bydgoszcz	Poland
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Centre Francois Baclesse	Caen	France
Ntymrhna Iurmzvtq Osvsbgngv Itq Mbwvc Sgbstrntwbvdmkxfombwcpkjbmju Ipctjmos Bpwxlbzx	Cracow	Poland
Aigohqe Uyxar Scxtlctup Lenxfm Db Bazmptr	Bologna	Italy
Iynbesuz Cukpal Ddehwdlxejiatmjxk	L'hospitalet De Llobregat	Spain
Hbdwjwqh Uvucxbzbkkuiw Hmflbabl Tgrxw y Prxovg Iiodcqbg Cnovuv dvektprfuotwinpvq (voii	Badalona	Spain
Hkmkcwun Vsih dydjthde	Barcelona	Spain
Ikllyymy Ccruh	Paris	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.12.2022
Italy	Not recruiting	01.12.2022
Poland	Not recruiting	01.12.2022
Spain	Not recruiting	01.12.2022

Trial locations

Investigated drugs:

BGB-A425 is a medication being tested to see if it can help treat advanced solid tumors. In this study, it is used together with other medications to see if it is safe and how well it works against cancer. The researchers are trying to find the best dose that patients can tolerate without too many side effects.

LBL-007 is another medication being studied for its potential to treat advanced solid tumors. It is used in combination with other drugs to check its safety and effectiveness. The goal is to find out how well it works in fighting cancer and what dose is best for patients.

Tislelizumab is a medication that helps the immune system fight cancer. It is used in this study with other drugs to see if it can improve treatment for patients with advanced solid tumors. The researchers are looking at how safe it is and how well it works when used with the other medications in the trial.

Investigated diseases:

Head and Neck Squamous Cell Cancer – This type of cancer originates in the squamous cells lining the moist surfaces inside the head and neck, such as the mouth, nose, and throat. It typically begins as a flat, thin cell layer and can develop into a tumor. As the disease progresses, it may invade nearby tissues and spread to lymph nodes in the neck. The cancer can further metastasize to other parts of the body if not managed. Symptoms often include a persistent sore throat, difficulty swallowing, and changes in voice. The progression can vary based on the location and size of the tumor.

Non-Small Cell Lung Cancer – 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 into a large mass. As it progresses, it may spread to nearby lymph nodes and other organs. The disease often develops slowly, but its progression can accelerate if it spreads beyond the lungs. Symptoms may include a persistent cough, chest pain, and shortness of breath. The rate of progression can differ based on the subtype and stage at diagnosis.

Renal Cell Carcinoma – This is a type of kidney cancer that originates in the lining of the small tubes in the kidney. It often begins as a single tumor within one kidney but can occur in both kidneys simultaneously. As the disease progresses, it may grow larger and invade nearby tissues or spread to other parts of the body. Symptoms can include blood in the urine, a lump in the abdomen, and unexplained weight loss. The progression of the disease can vary significantly among individuals.

Trial ID:

2022-500694-14-00

Protocol code:

BGB-900-102

NCT ID:

NCT03744468

Trial Phase:

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

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Study of BGB-A425, LBL-007, and Tislelizumab for Patients with Advanced Head and Neck Cancer, Lung Cancer, or Kidney Cancer

What is this study about?

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