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RecruitingPHASE1, PHASE2INTERVENTIONAL

A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers

This research is investigating a new medication called Marlotamig (also known as REGN7075). We're testing it on its own, and also in combination with Cemiplimab, sometimes with chemotherapy, for adults with advanced solid cancers. The main goals are to understand how safe Marlotamig is, how well people tolerate it, and to find the most effective dose when used with other treatments. We also want to see if these treatments can help shrink tumours. The study will look at any side effects, how the body processes the drugs, and whether the body creates antibodies against them. This helps us understand if the treatment is an effective option for cancer patients.

At a glance

Status
Recruiting
Phase
PHASE1, PHASE2
Sponsor
Regeneron Pharmaceuticals
Enrolment target
933
Start
21 Dec 2020
Estimated completion
07 Apr 2027

What is this study about?

This clinical trial is designed to investigate a new medication called Marlotamig (also known as REGN7075). It's being studied for people who have advanced solid tumours, which means cancers that have grown or spread.

The main aims of this study are to understand two very important things: firstly, how safe Marlotamig is and if people can tolerate it well, both on its own and when combined with another drug called Cemiplimab (sometimes with extra chemotherapy). Secondly, the study is trying to find the best dose of Marlotamig to give. We also want to see how effective these treatments are at helping to control the cancer and potentially shrink the tumours.

Researchers will also be carefully watching for any side effects people might experience. They'll also be looking at how the body uses and processes Marlotamig, and if the body develops a reaction to the study drugs that could make them less effective. This comprehensive approach helps us learn as much as possible about this new potential treatment.

Key takeaways

  • A new drug, Marlotamig, is being tested for advanced solid cancers.
  • The study checks the safety and effectiveness of Marlotamig alone and with other treatments.
  • Researchers want to find the best dose and monitor for side effects.
  • It's open to adults aged 18 and over with certain advanced cancers.
  • Participation involves regular visits and monitoring by the study team.

Who may be eligible?

To join this study, you would generally need to have a confirmed diagnosis of certain advanced solid cancers. Your general health and how well you can carry out daily activities will be assessed. You would also need to be willing to provide a fresh tissue sample from your tumour if requested.

There are also some reasons why you might not be able to join. For example, if you're already taking part in another clinical trial, have recently had certain other cancer treatments or major surgery, or have another serious illness that requires ongoing strong medication. The study team will review all your medical information carefully to see if this study is right for you and if it’s safe for you to take part.

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.

  1. Are you 18 years old or older?
  2. Do you have an advanced solid tumour diagnosis?
  3. Are you generally well enough to do your daily activities?
  4. Have you discussed your participation with your doctor?
  5. Are you currently not involved in another medical research study?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medication, Marlotamig, either on its own or with Cemiplimab, and potentially chemotherapy. You would have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how the treatment is working. Researchers would also be checking for any side effects. The total duration of your participation would depend on how your body responds to the treatment and the phase of the study you are in, but there would be follow-up appointments after the main treatment period.

Potential risks and benefits

Participating in a clinical trial might offer potential benefits, as you would have access to a new treatment a research drug that isn't widely available yet. There is no guarantee that the treatment will work for you, and it's possible it may not benefit you at all. All medications have potential side effects, and some serious side effects could occur. The research team will monitor you closely for any unwanted effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (57)

  • Valkyrie Clinical Trials
    Verified postcode
    Los Angeles, United States· Recruiting
  • University of California Los Angeles (UCLA) Medical Center
    Verified postcode
    Los Angeles, United States· Recruiting
  • The Regents of the University of California, San Francisco
    Verified postcode
    San Francisco, United States· Recruiting
  • University of Colorado Hospital - Anschutz Cancer Pavilion - Lung Cancer Clinic
    Verified postcode
    Aurora, United States· Recruiting
  • University of Florida Health
    Verified postcode
    Gainesville, United States· Recruiting
  • Moffitt Cancer Center
    Verified postcode
    Tampa, United States· Completed
  • University of Illinois Cancer Center
    Verified postcode
    Chicago, United States· Recruiting
  • University of Iowa Hospitals and Clinics
    Verified postcode
    Iowa City, United States· Recruiting
  • Dana Farber Cancer Institute Brookline Avenue
    Verified postcode
    Boston, United States· Withdrawn
  • START Midwest - Cancer & Hematology Centers of Western Michigan, PC
    Verified postcode
    Grand Rapids, United States· Recruiting
  • Rutgers Cancer Institute of New Jersey
    Verified postcode
    New Brunswick, United States· Recruiting
  • Memorial Sloan Kettering Cancer Center
    Verified postcode
    New York, United States· Recruiting

Common questions

What kind of cancer is this study for?

This study is for adults who have advanced solid tumours, which are cancers that have grown or spread in the body.

What is Marlotamig?

Marlotamig is a new, investigational drug that researchers are hoping could help treat certain cancers. It's also known as REGN7075.

Will I receive chemotherapy?

Depending on which group you are in, you might receive Marlotamig on its own, with Cemiplimab, or with Cemiplimab and chemotherapy.

What are the main goals of the study?

The study aims to see how safe this new drug is, how well people tolerate it, to find the best dose, and to see if it's effective at treating cancer.

Can I leave the study at any time?

Yes, you are free to leave the study at any point without it affecting your future medical care.

How to find out more

Clinical Trials Administrator

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

Interested in taking part?

Register your interest

Share your details and the research team for "A Trial to Find Out How Safe REGN7075 is and How Well it Wor…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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