Study Details

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CHS-388-202- A Trial of Casdozokitug in Combination With Toripalimab Plus Bevacizumab

This research is being done in participants who have Hepatocellular Carcinoma (HCC), also referred to as Liver Cancer, to evaluate how 3 drugs work in combination, and which dose is the best to treat your disease. The 3 drugs are casdozokitug (casdozo-key-tug), toripalimab (tor-i-pal-i- mab) and bevacizumab (bev-uh-siz-oo-mab). Toripalimab and bevacizumab have been approved by the Food and Drug Administration (FDA) to treat other cancers, but not Liver cancer. Casdozokitug has not been approved by the FDA to treat any cancers.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

If you are eligible to participate in this study, you will undergo one or more of the study procedures at each study visit. Some of these procedures may no longer be necessary depending on the visit day in the study treatment cycle. Your study doctor will let you know if you are not required to undergo a procedure. Please note that you may be asked to repeat a procedure or test and/or have additional procedures if your study doctor feels it is needed to evaluate your condition. You may participate in the study for up to 2 years. Thirty days after your last dose of study drug, you will return to the clinic for a Safety Follow-up visit. You will then be contacted by phone, or during a regular office visit, 90 days after your last dose of study drug to see if you have started any new medications and see how you are feeling. For 4 years after you begin this study, we will contact you every 6 months to see how you are doing.

In-person visits:
12

Total length of participation:
24 months

Looking for Specific Volunteers

Able to participate:

Disease that is not amenable to curative surgical and/or locoregional therapies or progressive disease after surgical and/or locoregional therapies.
Unresectable locally advanced or metastatic HCC with clinically confirmed diagnosis
An Eastern Cooperative Oncology Group performance status of 0 or 1.
Documented serology test for hepatitis by screening hepatitis B surface antigen, antibody to hepatitis B core antigen (anti-HBc Ab), and antibody to hepatitis C virus.
A baseline tumor tissue sample is mandatory. An archival tumor tissue sample (block or 10-15 unstained slides with associated pathology report) is acceptable.

Not eligible if:

Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior
Has a history of or current hepatic encephalopathy.
Unable to undergo disease evaluation with CT or MRI because of contrast allergy or other contraindication.
History of Grade 4 allergic or anaphylactic reaction to any monoclonal antibody therapy
Has any ongoing radiation-related toxicity or an ongoing corticosteroid requirement due to radiation

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Secondary Visit Location

Gastrointestinal (GI) Medicine
UNC Hospitals Hillsborough Campus
460 Waterstone Dr, Hillsborough, NC 27278, USA

Additional Study Information

Principal Investigator

Jingquan Jia
Medicine- Oncology

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Colorectal)
Kidneys and Liver

IRB Number

24-3054

ClinicalTrials.gov

NCT06679985