Active not recruitingPHASE1INTERVENTIONAL

Study of TSR-042, an Anti-programmed Cell Death-1 Receptor (PD-1) Monoclonal Antibody, in Participants With Advanced Solid Tumors

This study is looking at a new medicine called dostarlimab for people who have advanced solid tumours and have already tried other treatments without success. It's a 'first-in-human' study, meaning it's one of the first times this drug is being tested in people. The main goals are to figure out the safest dose, how the drug acts in the body, and if it helps to treat the cancer. The study will happen in stages. First, different doses will be tested carefully to find the best amount. Then, the drug will be given in fixed doses, and finally, it will be tested in groups of people with specific types of advanced solid tumours to see if it helps reduce their cancer.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Tesaro, Inc.

Enrolment target

730

Start

07 Mar 2016

Estimated completion

25 Jan 2027

Neoplasms

What is this study about?

Imagine your body has a natural defence system, like a security guard, that usually spots and fights off unhealthy cells. Sometimes, cancer cells can put on a disguise to hide from this security guard. The new medicine, dostarlimab, is like a signal to your body's defence system to help it recognise and attack these hidden cancer cells again.

This study, called a Phase 1 study, is the very first step in testing a new treatment like dostarlimab in people. The main aim is to check if the medicine is safe and to find the best dose to give. It's being offered to people with advanced solid tumours, which means cancers that have spread and for which other treatments haven't worked or can't be used.

The study will carefully increase the dose of dostarlimab in small steps, watching closely to see how people react. Once a safe and effective dose range is found, the study will then look at fixed doses and finally examine how well dostarlimab works against specific advanced solid tumours, such as certain types of advanced womb cancer.

Key takeaways

It's about a new drug (dostarlimab) for advanced solid cancers.
The main goals are checking safety and finding the best dose.
It's for people whose cancers haven't responded to other treatments.
Participation involves receiving the drug and regular check-ups.
Potential benefits include access to a new treatment; risks include side effects.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old. You must have an advanced solid tumour that has either come back or gotten worse after trying other cancer treatments, or you can't tolerate those treatments.

Depending on which part of the study you might join, there are slightly different requirements. For example, some parts of the study are open to anyone with an advanced solid tumour, while other parts are more specific. For certain groups, like those with advanced womb cancer, you would need to have specific types of cancer, and it would need to have progressed after certain previous treatments. You might also need to have measurable cancer spots that can be tracked.

The doctors will also check specific features of your cancer, such as certain genetic markers, to see if it's the right fit for the study. They will also need to review scans of your tumour to confirm it meets the study's requirements.

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 at least 18 years old?
Do you have an advanced solid tumour that has either returned or progressed after other treatments, or you can't tolerate those treatments?
Do you have a specific type of advanced solid tumour mentioned in the study (e.g., advanced womb cancer for certain parts of the study)?
Are you able to have regular scans and check-ups?
Have you discussed your previous cancer treatments with your doctor?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will receive doses of the study drug, dostarlimab. In the first part of the study, the dose you receive will be carefully decided, starting low and slowly increasing, with doctors checking you very closely. Later parts of the study will involve receiving fixed doses of either 500mg every three weeks or 1000mg every six weeks. You will have regular appointments and tests to check your health, how the drug is affecting you, and if your cancer is responding. The total duration of your participation will depend on how you respond to the treatment and the stage of the study you are in, but it will involve ongoing check-ups and monitoring.

Potential risks and benefits

Potential benefits of joining this study could include access to a new treatment that might help reduce your cancer when other options haven't worked. However, it's important to remember that this is a new drug, and not everyone will benefit. Potential risks include side effects from the medication, which will be carefully monitored by the study team. Every effort will be made to manage any side effects you might experience. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (105)

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

GSK Investigational Site
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Birmingham, United States
GSK Investigational Site
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Goodyear, United States
GSK Investigational Site
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Scottsdale, United States
GSK Investigational Site
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Fayetteville, United States
GSK Investigational Site
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Encinitas, United States
GSK Investigational Site
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La Jolla, United States
GSK Investigational Site
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Los Angeles, United States
GSK Investigational Site
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Newport Beach, United States
GSK Investigational Site
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San Francisco, United States
GSK Investigational Site
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San Marcos, United States
GSK Investigational Site
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Santa Monica, United States
GSK Investigational Site
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Washington D.C., United States

Common questions

What is a 'solid tumour'?

A solid tumour is a growth of abnormal cells that forms a lump, like breast cancer or bowel cancer, as opposed to blood cancers like leukaemia.

What does 'advanced' cancer mean?

Advanced cancer usually means the cancer has spread from where it started to other parts of the body, or it has come back after previous treatment.

What is 'dostarlimab'?

Dostarlimab is a new type of cancer medicine, sometimes called immunotherapy. It works by helping your body's own immune system find and fight cancer cells.

What does 'Phase 1 study' mean?

A Phase 1 study is the first step in testing a new drug in humans. Its main goal is to find out if the drug is safe, what side effects it might have, and what is the best dose to give.

Will I definitely get the new medication?

Yes, everyone in this particular study will receive the active study drug, dostarlimab. This is an 'open-label' study, meaning both you and your doctors will know you are receiving the drug.