Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2a, double-blind, placebo-controlled, multi-center, randomized study evaluating LSTA1 when added to standard of care (SoC) versus standard of care alone in subjects with advanced solid tumors (BOLSTER)

This study is testing a new medicine called LSTA1 for people who have advanced head and neck cancer or a specific type of cancer affecting the bile ducts, called cholangiocarcinoma. Researchers want to find out if adding LSTA1 to the usual treatments (like chemotherapy or other cancer drugs) is safe and causes any side effects. They will also be looking to see if this new combination helps control the cancer for longer, makes tumours shrink, or helps people live longer. Half of the participants will receive LSTA1 along with their standard care, while the other half will receive a dummy drug (placebo) with their standard care. This helps researchers compare the effects accurately.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Lisata Therapeutics Inc.

Enrolment target

Start

14 Aug 2023

Head and neck cancer Cholangiocarcinoma

What is this study about?

This research study is called 'BOLSTER' and it's looking at a new medicine named LSTA1. The study is for people who have advanced head and neck cancer or a type of cancer that affects the bile ducts, called cholangiocarcinoma. When cancer is 'advanced', it often means it has grown or spread. This study wants to see if adding LSTA1 to the treatments people are already receiving could be helpful.

Think of it like this: if you have a recipe that usually uses a few ingredients, this study wants to see what happens if you add one more special ingredient (LSTA1) to that same recipe. Researchers will carefully watch to see if this new ingredient causes any unexpected problems or side effects. They also want to find out if it makes the overall 'dish' (your health) better, perhaps by slowing down the cancer's growth or shrinking it.

This kind of study helps doctors learn more about new ways to treat serious illnesses. By taking part, you could be helping to find better treatments for future patients, even if it doesn't directly benefit you. Every new medicine we have today started with studies just like this one.

Key takeaways

This study tests a new drug (LSTA1) for advanced head and neck cancer or cholangiocarcinoma.
It aims to see if LSTA1 is safe and helps control cancer when added to usual treatments.
Half of participants will get LSTA1, half will get a dummy pill (placebo), plus their regular treatment.
Scientists are especially interested in side effects, but also if it helps tumours shrink or people live longer.
Participation involves regular hospital visits for checks and tests.

Who may be eligible?

To join this study, people generally need to be 18 years old or older. The study is open to both men and women.

Participants must have either advanced head and neck cancer or advanced cholangiocarcinoma (a type of bile duct cancer). These are very specific conditions, and the study team will need to confirm your diagnosis.

There will be other health checks and medical requirements that the study doctors will go through with you to make sure the study is a safe and suitable option for you.

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 over?
Do you have advanced head and neck cancer?
Or do you have advanced cholangiocarcinoma (a type of bile duct cancer)?
Are you able to attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would receive either the new treatment LSTA1 or a dummy treatment (placebo), both given alongside the standard care for your cancer. Neither you nor your doctor would know which treatment you are receiving, which helps make the study fair and accurate. You would need to make regular visits to the hospital for medical checks, blood tests, and scans to see how you are responding to the treatment and to monitor for any side effects. The exact number of visits and the full duration of your participation would depend on how your treatment progresses and the study's follow-up plan, but the medical team will explain this in detail.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as access to a new treatment (LSTA1) that isn't widely available yet, and receiving very close medical monitoring. However, there are also potential risks; LSTA1 might cause unexpected side effects that we don't fully know about yet, or it might not help your condition. The standard treatments (like GEMCITABINE, DURVALUMAB, CISPLATIN, PACLITAXEL) also have their own known side effects. It's very important to remember that you can stop participating in 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.

—
Unverified
Spain

Common questions

What is 'standard of care'?

Standard of care means the best, most accepted treatments currently available for your type of cancer.

What is a 'placebo'?

A placebo is an inactive substance, sometimes called a 'dummy drug', that looks exactly like the real medicine but contains no active ingredients. It helps researchers compare the new drug's effects.

What does 'double-blind' mean?

Double-blind means that neither you nor your study doctor will know whether you are receiving the new treatment or the placebo. This helps prevent bias in the results.

Will I still get my usual cancer treatment?

Yes, everyone in this study will continue to receive the standard, approved treatments for their cancer, with LSTA1 or a placebo added on top.

What kind of cancers are included in this study?

This study is for people with advanced head and neck cancer or a type of bile duct cancer called cholangiocarcinoma.