Phase I Study of HLX13 vs. YERVOY® for Unresectable Liver Cancer
This study is testing a new drug called HLX13 against an approved drug, YERVOY®, as a first treatment for people with liver cancer (unresectable hepatocellular carcinoma) that cannot be removed by surgery. It also includes OPDIVO® as part of the treatment. The main goals are to understand how HLX13 moves through the body (pharmacokinetics), its safety, and whether it causes an immune response. Researchers will also look at how well it works. You might be able to join if you are between 18 and 65 years old, weigh between 50 kg and 85 kg, and have not had other treatments for your liver cancer. The study is currently recruiting 246 participants, but its overall status is unclear.
- Study design
- This is a Phase I, randomized, double-blind study, meaning participants are randomly assigned to a treatment group and neither you nor your doctor will know which drug you are receiving. It aims to enroll 246 participants.
- What's involved
- You would receive treatment with either HLX13, YERVOY®, or OPDIVO® on the first day of each 3-week cycle, for up to 4 cycles. Some participants may continue with OPDIVO® monotherapy.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures drug levels for up to 21 days after the first dose and up to 78 days (20 weeks) after the fourth dose.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Phase I Clinical Study To Evaluate Pharmacokinetic Profile, Safety, Efficacy and Immunogenicity Of Ipilimumab Biosimilar HLX13 Vs. YERVOY® (US-Sourced YERVOY®) As A First-Line Treatment For Patients With Unresectable Hepatocellular Carcinoma
At a glance
Conditions
NCT07176650
Where you'd take part
This study runs at 51 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Affiliated Hospital of Jining Medical University
Jining, Chinano site contact published
Recruiting
American Oncology Network Vista Oncology Division/Physician Partner Associate
Olympia, Washingtonno site contact published
Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Chinano site contact published
Recruiting
Cancer Specialists of North Florida
Jacksonville, Floridano site contact published
Not yet recruiting
Chengdu Fifth People's Hospital
Chengdu, Chinano site contact published
Recruiting
D&H National Research Centers, LLC
Margate, Floridano site contact published
Recruiting
Dongguan People's Hospital
Dongguan, Chinano site contact published
Recruiting
Florida Clinical Trials Group
Plantation, Floridano site contact published
Not yet recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Area under the serum concentration-time curve from time 0 to 21 days (AUC0-21d) after the 1st dosefrom time 0 to 21 days after the 1st dose (3 weeks)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
- Area under the serum concentration-time curve within a dosing interval at steady-state (AUCss) after the 4th dosefrom time 0 to 78 days after the 4th dose (20 weeks)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan