RecruitingHepatocellular Carcinoma (HCC)
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
Eligible age
18–65 yrs
Accepts
All genders
Locations
5 states
Healthy volunteers
No
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About this study
This is a multicenter, randomized, double-blind, parallel-controlled, phase I clinical study to evaluate the PK characteristics, safety, efficacy, and immunogenicity of HLX13 and US-sourced YERVOY® in patients with unresectable hepatocellular carcinoma who have not received prior systemic therapy.
Sponsor: Shanghai Henlius Biotech
You may qualify if…
- ✓ 1. Subjects must have signed and dated an IRB/IEC-approved written informed consent form (ICF) in accordance with regulatory and institutional guidelines.
- ✓ 2. Male or female, 18 years ≤ age ≤ 65 years at the time of signing the ICF.
- ✓ 3. Body weight: 50 kg-85 kg.
- ✓ 4. Histologically diagnosed hepatocellular carcinoma (HCC); and must have an advanced HCC, defined as: a) not eligible for curative surgical and/or locoregional therapies; or b) progressive disease after surgical and/or locoregional therapies. Subjects with only a radiologic diagnosis of hepatocellular carcinoma may be enrolled for screening in the study but histological confirmation is mandatory prior to randomization.
- ✓ 5. At least one measurable lesion as assessed by investigator based on RECIST v1.1 within 4 weeks prior to the first dose in this study. The measurable lesion is not from sites that have been previously treated with surgery, radiotherapy, and/or locoregional therapy.
- ✓ 6. No systemic therapy for relapsed metastatic or advanced hepatocellular carcinoma prior to screening. Note: prior neo-adjuvant or adjuvant systemic therapy is permitted if recurrence occurs ≥12 months after treatment completion.
- ✓ 7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 within 7 days prior to the first dose.
- ✓ 8. Cirrhotic status of Child-Pugh Class A within 7 days prior to the first dose.
You may not qualify if…
- ✕ 1. With other histopathological types of hepatocellular carcinoma, including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or mixed cholangiocarcinoma and hepatocellular carcinoma.
- ✕ 2. Other malignancies active within 3 years prior to or at screening except for localized tumors that have been cured such as basal cell carcinoma, squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
- ✕ 3. Liver transplant, or organ allograft or allogeneic bone marrow transplantation prior to screening, or the above transplantation is scheduled during the study.
- ✕ 4. History of hepatic encephalopathy prior to screening.
- ✕ 5. Clinically significant ascites.
- ✕ 6. Patients with tumor thrombus at the main portal vein (Vp4), or inferior vena cava prior to screening, or clear invasion into the bile duct, or HCC with ≥50% liver occupation.
- ✕ 7. Presence of nervous system disorders at screening.
- ✕ 8. Evidence of portal hypertension with bleeding esophageal or gastric varices within 6 months prior to the randomization. The aforementioned patients have undergone endoscopy to exclude those with high hemorrhage risk may be enrolled. For a patient receiving endoscopy within 6 months prior to randomization, repeat examination is not required.
Where it's recruiting
California
Glendale
Florida
Jacksonville · Margate · Orange City · Plantation …
Tennessee
Brentwood
Texas
Houston
Washington
Olympia · Tacoma
Source: ClinicalTrials.gov · NCT07176650 · last updated 2026-03-16