Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

Phase 1-2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Various Combinations of BGB-A425 and LBL-007 with Tislelizumab in Patients with Advanced Solid Tumors

This research is an early-stage clinical trial (Phase 1 and 2) investigating new treatments for specific advanced cancers: head and neck, kidney, and non-small cell lung cancer. The study is testing combinations of three medications: BGB-A425, LBL-007, and Tislelizumab. The main goals are to find a safe and tolerable dose for these drug combinations and to monitor any side effects. Researchers will also look to see if the treatments show any early signs of shrinking tumours or stopping their growth. This information helps understand if these new combinations could be helpful for future cancer treatments.

At a glance

Status

Ongoing, recruiting

Phase

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

Sponsor

Beigene Ltd.

Enrolment target

Start

24 Oct 2022

Head and Neck Squamous Cell Cancer Renal Cell Carcinoma Non-Small Cell Lung Cancer

What is this study about?

This clinical trial is designed to investigate new medicines for people with advanced forms of head and neck squamous cell cancer, renal cell carcinoma (a type of kidney cancer), and non-small cell lung cancer. It's an early-stage study, meaning it's among the first times these specific drug combinations are being tested in humans.

The main purpose of the study is to understand how safe these new drug combinations are and what side effects they might cause. Researchers will also look at how the body handles these medicines. Initially, the study will focus on finding the highest dose that can be given without causing too many serious side effects. Once a safe dose is identified, the study will expand to see if these treatments have a positive effect on tumour growth.

Participants will receive combinations of three specific drugs: BGB-A425, LBL-007, and Tislelizumab. These are experimental treatments, and the research will carefully monitor patients for any changes in their health, including how their tumours respond. The findings from this trial will help determine if these drug combinations should be studied further in larger groups of patients.

Key takeaways

Tests new drug combinations for advanced head and neck, kidney, and lung cancers.
Early-stage study focused on safety and finding the right dose.
Will monitor for side effects and early signs of tumour response.
Involves three experimental drugs: BGB-A425, LBL-007, and Tislelizumab.
Participation involves regular hospital visits for checks and treatments.

Who may be eligible?

To be considered for this study, you must be at least 18 years old. There's no upper age limit, meaning people of all adult ages can potentially take part.

Both men and women are welcome to participate in this research. The study needs to include a diverse group of patients to get a full picture of how the treatments work.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have advanced head and neck squamous cell cancer, renal cell carcinoma, or non-small cell lung cancer?
Are you generally well enough to participate in a clinical trial?
Are you able to attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll receive a combination of the experimental drugs BGB-A425, LBL-007, and Tislelizumab, given over a period. You'll have regular hospital visits for health checks, including blood tests, physical examinations, and scans to monitor your cancer and how well the treatment is working. The study is divided into two parts: an initial dose-finding stage and a dose expansion stage. The total duration of your participation will depend on how you respond to the treatment and the study's design, but it will involve ongoing assessments as long as you are receiving the study drugs and for a follow-up period afterwards.

Potential risks and benefits

Participating in this study might offer a chance to try new treatments for your cancer that aren't yet widely available. However, since these are experimental drugs, there's always a risk of unexpected side effects, some of which could be serious. The research team will closely monitor you and manage any side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France
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Unverified
Spain
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Unverified
Poland
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Unverified
Italy

Common questions

What kind of cancers is this study for?

This study is for advanced head and neck squamous cell cancer, a type of kidney cancer called renal cell carcinoma, and non-small cell lung cancer.

What drugs are being tested?

The study is testing combinations of three drugs: BGB-A425, LBL-007, and Tislelizumab.

Why are they doing this study?

The main aims are to find a safe dose for these drug combinations, understand their side effects, and see if they show early signs of making tumours shrink or stopping their growth.

Is this a new treatment?

Yes, this is an early-stage study, meaning these drug combinations are new and are among the first to be tested in people.

Will I get better if I join?

While the treatments are designed to help, there's no guarantee they will work for everyone. The study aims to find out if they are effective.