Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

Phase 1/2 Study of BDC-1001 as a Single Agent and in Combination with Nivolumab in Patients with Advanced HER2-Expressing Solid Tumors

This research is a 'Phase 1/2' study looking at a new medicine called BDC-1001. It's being tested in adults who have advanced cancers which show a specific marker called HER2. The study will look at BDC-1001 by itself and also combined with an existing medicine called Nivolumab (also known as Opdivo). The main aim of this first part of the study is to carefully check the safety of these treatments and identify any side effects that people might experience. Researchers will also look at how the body handles the new medicine and if the treatments can help shrink the cancer or stop it from growing. This type of study is crucial for understanding new treatments before they can be more widely used.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Bolt Biotherapeutics Inc.

Enrolment target

Start

14 Nov 2024

Advanced HER2-Expressing Solid Tumors.

What is this study about?

This study is a clinical trial, which means it's a carefully planned research study involving people. Its main purpose is to explore a new potential treatment for certain advanced cancers. These are cancers that have spread or are difficult to treat, and they specifically show a marker called HER2. You might have heard of HER2 in relation to breast cancer, but it can appear in other types of cancer too.

The new drug being tested is called BDC-1001. In this study, doctors want to see what happens when BDC-1001 is given on its own, and also when it's given together with an existing cancer medicine called Nivolumab (you might know it as Opdivo). Nivolumab is an immunotherapy, which helps your body's immune system fight cancer. Combining treatments can sometimes be more effective than a single treatment.

Because this is a 'Phase 1/2' study, the primary focus is on safety. Researchers will be closely watching for any side effects and trying to find the right dose of the medicines. They will also collect information on how the treatments are absorbed and processed by the body, and look for early signs of whether the treatments are having a positive effect on the cancer, such as shrinking tumours or stopping them from growing.

Key takeaways

This study is for adults with advanced cancers that have the HER2 marker.
It tests a new drug called BDC-1001, alone or with Nivolumab (Opdivo).
The main goals are to check for safety, side effects, and early signs of effectiveness.
Participation involves regular hospital visits for treatments and checks.
You can stop participating at any time.
It could offer access to a new treatment, but also carries potential risks.

Who may be eligible?

To join this study, people must be at least 18 years old. Both men and women can take part.

You would need to have an advanced cancer which has a specific protein on its surface called HER2. This means that your cancer has either spread to other parts of your body, or it's a type that hasn't responded well to standard treatments.

There will be other detailed medical checks to make sure the study is a safe and suitable option for you. These checks are important to protect your health and ensure the study gets clear results.

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 a diagnosis of advanced cancer?
Has your doctor confirmed that your cancer has the 'HER2-expressing' marker?
Are you currently receiving treatment or have you finished other treatments for your cancer?
Are you able to attend regular appointments at the study hospital or clinic?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the new drug BDC-1001 on its own, or BDC-1001 combined with Nivolumab, as an infusion (given through a drip into your vein). The dose and how often you receive the treatment would be decided by the study doctors.

You would have regular visits to the hospital or clinic. These visits would involve various assessments, such as blood tests, physical examinations, and scans to monitor your health and how the treatment is affecting your cancer. Doctors will also carefully track any side effects you might experience.

The total length of time you participate would depend on how your body responds to the treatment and what the doctors decide. There would also be follow-up appointments after your treatment finishes to monitor your long-term health. The study team will explain the schedule for your specific situation in detail.

Potential risks and benefits

Taking part in a clinical trial means you might have access to a new treatment before it's widely available. The potential benefit is that the treatment could help your cancer or improve your quality of life. However, like all medicines, these drugs can cause side effects, some of which might be serious. Because BDC-1001 is new, not all side effects are fully known yet. The study team will provide you with a full list of known and potential risks. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
France

Common questions

What does 'HER2-expressing' mean for my cancer?

It means your cancer cells have a particular protein called HER2 on their surface, which the new drug BDC-1001 is designed to target.

What is Nivolumab (Opdivo)?

Nivolumab is a type of immunotherapy that helps your own immune system recognise and fight cancer cells.

What does 'Phase 1/2' mean?

It means this is an early stage of testing. Phase 1 focuses on safety and finding the right dose, while Phase 2 begins to look at how well the treatment works.

Will I definitely get the new drug?

Yes, everyone in this study will receive either BDC-1001 by itself or BDC-1001 combined with Nivolumab. There is no placebo group.

How long will I be in the study?

The duration varies for each person, depending on how they respond to the treatment and their health. The study team will discuss the expected timeline with you.