RecruitingPHASE1INTERVENTIONAL

A Study of MGC026 in Participants With Advanced Solid Tumors

This study is looking at a new medicine called MGC026 for people with advanced solid cancers that have either returned after treatment or spread to other parts of the body. The main goals are to understand how safe the medicine is, what side effects it might cause, and if it shows any signs of helping to treat the cancer. Participants will receive MGC026 through a drip into their vein. Doctors will carefully watch for any side effects and check how the cancer responds. The study is in its early stages (Phase 1), meaning it's one of the first times this medicine is being tested in people. It aims to find the best dose to use in future studies.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

MacroGenics

Enrolment target

250

Start

06 Mar 2024

Estimated completion

01 Oct 2028

What is this study about?

This study is investigating a new medicine, called MGC026, for people who have advanced solid cancers. 'Advanced' means the cancer may have spread to other parts of the body or come back after previous treatments. The treatment is given through a drip into a vein. Doctors want to learn a lot about MGC026 in this early stage study.

The main aim is to understand the safety of MGC026. This means finding out what side effects it might cause and how well people can tolerate the treatment. They also want to understand how the body handles the medicine and if it shows any early signs of helping to shrink or control the cancer. This information will help them decide if MGC026 is promising enough to study further in more people.

Participants will receive MGC026 in different dose levels. Doctors will carefully monitor everyone to see how they react to the medicine. The study involves a starting phase to find the safest and most effective dose, and then a second phase where more people will receive that chosen dose. This careful process helps ensure that new treatments are tested safely and effectively.

Key takeaways

It's a Phase 1 study, focusing on safety and finding the right dose.
The new medicine, MGC026, is for various advanced solid cancers.
Treatment is given through a drip into your vein.
Participation involves regular checks for side effects and cancer response.
There are potential benefits and risks, and you can leave the study at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old. You must have a type of advanced solid cancer that is either locally advanced (meaning it has grown into nearby tissues but cannot be removed by surgery), or has spread to other parts of the body. Cancers included are head and neck, lung, bladder, certain soft tissue cancers (sarcoma), endometrial, melanoma, prostate, breast, ovarian, cervical, bowel, stomach, gullet, pancreas, kidney, and liver cancers.

Your general health needs to be good enough to take part, and blood tests will be taken to check this. You'll also need to have a tumor sample available, either from a previous biopsy or by having a new one if it's safe to do so. If you could become pregnant, you must be willing to use effective birth control during and for several months after the study treatment. You cannot be pregnant or breastfeeding.

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 an advanced solid cancer that has returned or spread?
Are you able to provide a recent or new tumour sample?
Are you willing and able to use effective birth control if applicable?
Are you generally well enough to participate in a clinical study?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the study medicine, MGC026, through a drip into a vein. The doctors will decide your dose when you start. You could receive this treatment for up to 35 cycles, as long as the medicine is not causing severe side effects and your cancer is not getting worse. Throughout the study, you will have regular check-ups. This will involve monitoring for any side effects, having blood tests for routine checks and for research purposes, and having scans or other tests to see if your cancer is responding to the treatment. The total duration of your participation will depend on how you respond to the treatment.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as access to a new experimental treatment that is not yet widely available. While MGC026 is being studied to see if it can help treat cancer, there is no guarantee that it will be effective for you. There are also potential risks, as the medicine might cause side effects, some of which could be serious. The study team will carefully explain all known and potential risks. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (12)

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

The Angeles Clinic and Research Institute
Verified postcode
Los Angeles, United States· Recruiting
START Midwest
Verified postcode
Grand Rapids, United States· Recruiting
START-New York Long Island
Verified postcode
Lake Success, United States· Recruiting
Providence Cancer Institute
Verified postcode
Portland, United States· Recruiting
The University of Texas MD Anderson Cancer Center
Verified postcode
Houston, United States· Recruiting
University of Texas Health Science Center at Houston
Verified postcode
Houston, United States· Recruiting
START Mountain Region
Verified postcode
West Valley City, United States· Recruiting
ICON Cancer Centre Wesley
Verified postcode
Auchenflower, Australia· Recruiting
ICON Cancer Centre Kurralta Park
Verified postcode
Kurralta Park, Australia· Recruiting
Austin Health- Olivia Newton John Cancer Center
Verified postcode
Heidelberg, Australia· Recruiting
Oxford University Hospitals NHS Foundation Trust
Verified postcode
Oxford, United Kingdom· Recruiting
The Royal Marsden NHS Foundation Trust
Verified postcode
Sutton, United Kingdom· Recruiting

Common questions

What does 'Phase 1' mean?

Phase 1 means this is one of the first times this new medicine is being tested in people. The main goals are to find out if it's safe and to determine the best dose to use.

What kind of cancer does this study focus on?

This study is for people with various types of advanced solid cancers that have spread or come back after previous treatments. Examples include lung, breast, bowel, and ovarian cancer.

How will I receive the medicine?

The study medicine, MGC026, will be given to you through a drip directly into a vein (intravenously).

Will this medicine cure my cancer?

This is a new medicine, and while doctors hope it might help, there's no guarantee it will cure your cancer. The study is designed to see if it shows promising results.

How long will I be on the treatment?

You could receive treatment for up to 35 cycles, as long as it's safe for you and your cancer isn't getting worse. The study team will discuss this more specifically with you.

How to find out more

Global Trial Manager

info@macrogenics.com 301-251-5172 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.