Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Phase IB Study to Assess the Safety, Tolerability and Efficacy of PM14 in combination with Atezolizumab in Pretreated Patients with Selected Advanced Solid Tumors

This is an early-stage study looking into a new treatment approach for advanced cancers that have already received previous treatments. The study combines two existing medications, PM14 and atezolizumab, to see how they work together. Doctors are carefully checking if this new combination is safe for people to take and if they can tolerate it well. They also want to see if it has any positive effects on treating these cancers. This type of study, often called a Phase 1 study, is important for understanding new treatments in a small group of people before they can be studied more widely.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Pharma Mar S.A.

Enrolment target

Start

23 Jul 2024

Advanced solid tumors

What is this study about?

This study is about exploring a new way to treat certain advanced cancers. We call these 'solid tumors' because they form a lump or mass, unlike blood cancers. These are cancers that have unfortunately grown or spread and have already been treated with other medicines in the past. Researchers are looking at a combination of two medications: PM14 and atezolizumab.

Atezolizumab is a type of medicine called immunotherapy. It works by helping your own immune system find and fight cancer cells. The other medicine, PM14, is also being tested to see how it can help. The main goal of this particular study is to see if giving these two medicines together is safe and if people can take them without too many problems. This is a very early step in testing new treatments.

Studies like this are crucial because they help doctors learn which new treatments might be promising. By understanding how new drug combinations affect a small group of people, scientists can decide if it's worthwhile to continue testing them in larger studies. The hope is to find new and more effective ways to treat difficult cancers.

Key takeaways

This study is testing a new combination of two cancer drugs.
It's for people with advanced cancers that have already been treated.
The main goal is to check for safety and how well people tolerate the treatment.
It's an early-stage (Phase 1) study, important for developing new treatments.
Participants must be 18 or older with specific types of solid tumors.

Who may be eligible?

This study is open to adults aged 18 years and older. It includes both men and women.

To be considered for this study, you would need to have certain types of advanced cancer (also known as 'solid tumors') that have already been treated with other medicines. The doctors running the study will carefully check your medical history and current health to see if you meet all the specific requirements.

It's important to remember that not everyone with advanced cancer will be able to join. There are usually strict healthy criteria and specific cancer types that are included or excluded to make sure the study is safe and effective for participants.

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 type of advanced solid tumor (cancer that forms a lump)?
Has your cancer been treated with other medicines before?
Are you able to attend regular clinic appointments and tests?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the two study medications, PM14 and atezolizumab, according to a schedule set by the study doctors. You will have regular visits to the clinic for various checks and tests. These might include blood tests, physical examinations, and scans to see how your body is responding to the treatment.

The doctors and nurses will closely monitor you to see how you are tolerating the medicines and if you experience any side effects. You'll have frequent opportunities to discuss any concerns or changes in your health. The total duration of your participation, including follow-up appointments after treatment, will be explained to you in detail by the study team.

Potential risks and benefits

Participating in a study like this might offer a chance to try a new treatment combination that isn't yet widely available. While there's no guarantee it will help your specific condition, doctors learn valuable information that could benefit future patients. However, like all medicines, these study drugs may have side effects, and some could be serious. The research team will explain all known risks before you decide to join. Remember, 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
Spain

Common questions

What does 'advanced solid tumors' mean?

It means cancers that form a lump or mass and have spread or grown beyond where they started. They've also been treated before.

What is immunotherapy?

Immunotherapy is a type of treatment that uses your body's own immune system to fight cancer.

Will I definitely get the new treatment combination?

Yes, in this type of study, all participants receive the study medications. There isn't a placebo group in this early phase.

What is a 'Phase I' study?

It's an early-stage study, usually involving a small number of people, to check if a new treatment is safe and to find the right dose.

Will I have to pay to be in the study?

Typically, you don't pay for study medications or study-related tests and visits. Any specific costs will be fully explained by the research team.