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TREGCHECK 101

Head and Neck Cancer Study

Exploring a potential new treatment for people whose head and neck cancer has returned or worsened.

Now Enrolling

Tagmokitug (CHS-114) Phase 1 Arm 3: Advanced Solid Tumors

Trial ID: NCT05635643

About This Study

TREGCHECK™ 101

Head and Neck Cancer Study
Clinical Trial ID: NCT05635643

This study is evaluating an investigational drug called tagmokitug (CHS-114), in combination with toripalimab, for individuals with recurrent or metastatic head and neck cancer. This combination is investigational and not approved for any disease.

Who Can Participate?

Is this trial right for you?

You may be eligible for the TREGCHECK 101 clinical trial if:

You have been diagnosed with head and neck squamous cell carcinoma

Your cancer has worsened or come back after treatment

You have had fewer than two prior treatments for your condition

Only the study team can determine if you meet all eligibility criteria. For more information on eligibility criteria, please visit https://clinicaltrials.gov/study/NCT05635643#participation-criteria or contact one of the study sites. Your doctor may also be able to help you.

Frequently Asked Questions

Answers to Some Questions You May Have for the TREGCHECK™ 101 Clinical Trial

What is informed consent?

An Informed Consent Form helps you understand all the facts about your treatment.

What is this study about?

TREGCHECK 101 is testing an investigational drug called tagmokitug (CHS-114) to see if it can be tested further for people with head and neck cancer.

What is tagmokitug (CHS-114)?

Tagmokitug (CHS-114) is a type of drug called immunotherapy. Tagmokitug is an investigational drug and it is not approved by the FDA.

What is being tested?

Tagmokitug (CHS-114) is being tested to see if it may help the body’s own immune system to fight cancer. Tagmokitug is being tested in combination with another drug called toripalimab. Toripalimab is also an immunotherapy drug that has been approved by the FDA to treat a different form of head and neck cancer.

How do I sign up for the study?

First, talk to your doctor to see if this study may be right for you. You can also learn more about clinical trials by visiting a website like ClinicalTrials.gov or click here to find locations near you where the study is ongoing. Each study location has a website or phone number where you can ask questions. A nurse or study leader will help you understand what’s needed to join.

How long will I be in this study?

The treatment may be for up to 24 months, with follow-up visits for another 24 months or more.

Are there any disadvantages to taking part in this study?

The disadvantages of taking part in this study are those associated with treatment such as side effects and follow up as well as the time and inconvenience to you of attending the research site for further visits.

Will I have to pay for anything?

You will not need to pay for study drug tagmokitug (CHS-114), toripalimab, medical visits, laboratory tests, or any imaging and procedures that may be done as part of the study.

What to Expect

Guiding You Through Each Step with Care

If you qualify and choose to participate in our TREGCHECK 101 clinical trial, here’s what the process typically involves:

1

Screening

After you sign an Informed Consent Form, the study team will evaluate you to confirm that you can participate in the study.

2

Treatment

You will receive tagmokitug (CHS-114) and toripalimab once every three weeks, up to 24 months.

3

Follow-Up

Your health and disease status will be monitored for several years following treatment.

TREGCHECK 101 Trial Sites

Finding a location that works for you

This study is offered at select research sites. Find your nearest location below to learn more.

Study site locations are subject to change. Please visit ClinicalTrials.gov for the most up to date list of locations.

Patient Support

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