Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A Phase 1 Study of SGN-ALPV in Advanced Solid Tumors

This is an early-stage research study, called a Phase 1 trial, looking into a new medication named SGN-ALPV. It's designed for people with advanced solid cancers, such as those affecting the stomach, lungs, cervix, ovaries, or womb, as well as specific types of germ cell tumours. The main goal of this study is to carefully check the safety of SGN-ALPV. Researchers will be watching closely for any side effects and how severe they are when the medication is first given to people. They will also look at how much of the drug gets into the body. This helps them understand if the treatment is safe enough to study further and what might be the best dose.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Seagen Inc.

Enrolment target

Start

26 Jul 2022

What is this study about?

This study is a very early step in testing a new potential treatment called SGN-ALPV. When a new medicine is discovered, it goes through different stages of testing before it can be made widely available. This is a 'Phase 1' study, which means it's one of the first times this specific treatment is being given to people. The main purpose of this stage is not to cure cancer, but to understand how safe the treatment is, what side effects it might cause, and how the body handles it.

The study is recruiting people with several types of advanced solid cancers that have spread or are difficult to treat. These include certain cancers of the stomach, where the food pipe joins the stomach, and some lung cancers. It also includes cancers of the cervix, ovaries, and womb, as well as specific types of germ cell tumours that can affect different parts of the body. By looking at a range of different cancers, researchers can start to see if the treatment might have an effect across different tumour types while primarily focusing on safety.

While safety is the main focus, researchers will also be looking for early signs of whether the treatment is having any effect on the cancer. They'll measure things like whether tumours shrink, how long people live without their cancer getting worse, and overall survival. They will also check for substances in the blood that are sometimes used to monitor ovarian cancer. This information, combined with the detailed safety data, helps them decide if SGN-ALPV is promising enough to move into larger studies, which would then look more closely at how well it works.

Key takeaways

Tests a new drug (SGN-ALPV) for advanced solid cancers.
Main focus is safety and side effects (Phase 1 study).
Looks at how the body handles the new medicine.
Includes several types of stomach, lung, and gynaecological cancers.
Potential to access a new treatment not yet widely available.

Who may be eligible?

To be able to take part in this study, you must be at least 18 years old. The study is open to both men and women. Generally, participants will have advanced solid cancer that has spread or hasn't responded to standard treatments. This includes specific types of cancer affecting the stomach, food pipe (oesophagus), lungs, cervix, ovaries, or womb. It also includes certain types of germ cell tumours, which are rare cancers that can be found in different parts of the body.

The research doctor will need to check your medical history, recent scans, and blood test results carefully to make sure the study is a safe and suitable option for you. For instance, they will need to ensure your cancer is one of the specific types they are studying and that your general health is good enough to potentially receive the new treatment.

There will be other specific rules about who can and cannot join, such as how well your liver and kidneys are working, and what other treatments you might have had in the past. These rules are in place to keep participants safe and to make sure the study results are clear. Your doctor will discuss all these criteria with you in detail.

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.

Am I at least 18 years old?
Do I have one of the listed advanced solid cancers?
Am I currently receiving other cancer treatments?
Is my general health good enough for a clinical trial?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this clinical trial, you would first have a number of tests and checks to make sure you're suitable. Once enrolled, you would receive the study drug, SGN-ALPV, on a regular schedule, typically through an infusion, but the exact timings would be explained by the study team. You would need to attend regular clinic visits for blood tests, physical examinations, and possibly scans to monitor your health, check for any side effects, and see how your cancer is responding. These visits are very important to make sure you are safe and that the researchers are collecting all the necessary information. The study will continue for as long as the treatment is beneficial and you are tolerating it well, or until your doctor decides it's no longer the best option for you. After stopping the treatment, there will likely be follow-up visits to continue monitoring your health.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of accessing a new treatment that isn't yet widely available, which might help your condition. However, because this is a new treatment, there are also potential risks. We don't yet know all the possible side effects, and some could be serious. The study team will closely monitor you for any problems. You will always have the right 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
Spain
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Unverified
Sweden
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Unverified
Netherlands
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Unverified
Denmark

Common questions

What is a 'Phase 1' study?

It's the first stage of testing a new drug in people. The main goal is to find out if it's safe and what side effects it might cause, rather than primarily looking at how well it treats the disease.

What type of cancers is this study for?

It's for several types of advanced solid cancers, including those of the stomach entrance (gastroesophageal junction), lung (non-small cell), stomach, cervix, ovaries, womb, and certain types of germ cell tumours.

What is SGN-ALPV?

SGN-ALPV is the name of the new experimental drug being tested in this study.

Will this drug cure my cancer?

As this is a very early-stage study, the main aim is to understand safety. While researchers hope it shows promise, it's not designed or expected to be a cure at this stage.

Can I leave the study if I want to?

Yes, you are completely free to leave the study at any time, for any reason, without it affecting your future medical care.