Upper Gastrointestinal Cancer Study
Now Enrolling
Tagmokitug (CHS-114): Phase 1b, Cohorts A-C: Advanced Solid Tumors
Trial ID: NCT06657144
About This Study
TREGCHECK™ 102
Upper Gastrointestinal Cancer Study
Clinical Trial ID: NCT06657144
This study is evaluating the investigational drug called tagmokitug (CHS-114) in combination with toripalimab – with or without chemotherapy – for individuals with advanced or metastatic esophageal squamous cell carcinoma (ESCC), esophageal adenocarcinoma (EAC), gastroesophageal junction (GEJ) or gastric cancers.
This combination is investigational and not approved to treat any disease.
Who Can Participate?
Is this trial right for you?
You may be eligible for the TREGCHECK™ 102 clinical trial if:
Only the study team can determine if you meet all eligibility criteria. For more information on eligibility criteria, please visit https://www.clinicaltrials.gov/study/NCT06657144#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™ 102 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™ 102 is testing a combination of drugs including a new research drug called tagmokitug (CHS-114), toripalimab, with or without chemotherapy to see if they may work in people with certain advanced upper gastrointestinal cancers:
- esophageal squamous cell carcinoma (ESCC)
- esophageal adenocarcinoma (EAC)
- gastroesophageal junction (GEJ) cancer
- gastric cancer
What is tagmokitug (CHS-114)
Tagmokitug (CHS-114) is a type of drug called immunotherapy. Tagmokitug (CHS-114) is an investigational drug and is not yet 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 when administered in combination with another drug called toripalimab. Some study participants will also receive chemotherapy in combination with tagmokitug (CHS-114) and toripalimab. Toripalimab is also an immunotherapy drug that has been approved by the FDA to treat nasopharyngeal cancer. Toripalimab has not been approved by the FDA to treat upper gastrointestinal cancers.
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 two and a half years with follow-up visits of up to three years.
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. Procedures and chemotherapy that are part of your standard of care may be billed to your insurance company.
Will I be compensated?
You may be compensated for your time depending on the total number of study visits that you complete, or you may be reimbursed for the costs associated with your travel to the study site.
What to Expect
Guiding You Through Each Step with Care
If you qualify and choose to participate in our TREGCHECK™ 102 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, with or without chemotherapy, once every three weeks, over a period of two-and-a-half years.
3
Follow-Up
Your health and disease status will be monitored for several years following treatment.
TREGCHECK™ 102 Trial Sites
Finding a location that works for you
Patient Support
Patient Advocacy Organizations
