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Tests treatment safety and results for Hepatocellular Carcinoma (HCC)
Official title 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
ClinicalTrials.gov ID: NCT07176650
What this study is testing
What is HLX13?
HLX13 is an investigational medicine, being studied as a potential treatment for hepatocellular carcinoma (hcc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- people must have signed and dated an IRB/IEC-approved written informed consent form (ICF) in accordance with regulatory and institutional guidelines.
- Male or female, 18 years ≤ age ≤ 65 years at the time of signing the ICF.
- Body weight: 50 kg-85 kg.
- Histologically diagnosed hepatocellular carcinoma (HCC); and must have an advanced HCC, defined as: a) not eligible for curative surgical and/or...
- 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...
You likely can't join if
- With other histopathological types of hepatocellular carcinoma, including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular...
- Other malignancies active within 3 years prior to or at screening except for localized tumors that have been cured such as basal cell carcinoma...
- Liver transplant, or organ allograft or allogeneic bone marrow transplantation prior to screening, or the above transplantation is scheduled during...
- History of hepatic encephalopathy prior to screening.
- Clinically significant ascites.
- 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...
See the full eligibility criteria
Who can join
- people must have signed and dated an IRB/IEC-approved written informed consent form (ICF) in accordance with regulatory and institutional guidelines.
- Male or female, 18 years ≤ age ≤ 65 years at the time of signing the ICF.
- Body weight: 50 kg-85 kg.
- 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...
- 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...
- 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...
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 within 7 days prior to the first dose.
- Cirrhotic status of Child-Pugh Class A within 7 days prior to the first dose.
- Left ventricular ejection fraction (LVEF) ≥ 50% as measured by echocardiography.
- Normal major organ functions prior to the first dose.
- For patients with active hepatitis B virus (HBV), the HBV-DNA must be less than 500 IU/mL or 2500 copies/mL within 28 days prior to the randomization, an anti-HBV treatment (e.g., entecavir) has been started prior to...
- Women of childbearing potential should have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to the first dose.
What rules you out
- With other histopathological types of hepatocellular carcinoma, including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or mixed cholangiocarcinoma and hepatocellular carcinoma.
- 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...
- Liver transplant, or organ allograft or allogeneic bone marrow transplantation prior to screening, or the above transplantation is scheduled during the study.
- History of hepatic encephalopathy prior to screening.
- Clinically significant ascites.
- 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.
- Presence of nervous system disorders at screening.
- 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...
- Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 3 months prior to screening except for esophageal or gastric varices.
- History of non-healing wounds, bone fractures, or ulcers at risk of bleeding within 3 months prior to randomization.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to the randomization or those who receive minor surgical procedures (e.g., core biopsy) within 7 days prior to randomization.
- Known active or suspected autoimmune diseases prior to screening. Patients with stable disease who do not require systemic immunosuppressive therapy may also participate.
- Treatment with systemic corticosteroids (\> equivalent dose of 10 mg/day prednisone) or other immunosuppressive agents within 14 days prior to the first dose or during the study. However, for patients with conditions...
- Active co-infection with both hepatitis B and C (or detectable HBV surface antigen or HBV-DNA and HCV-RNA at screening), or hepatitis D infection in people with hepatitis B.
- people with a history of co-infection with both hepatitis B and C.
- Human immunodeficiency virus (HIV) infection prior to screening (or positive anti-HIV at screening).
- Any active infections (including, but not limited to bacteria, fungi, mycoplasma, chlamydia, and herpes zoster virus) requiring systemic treatment within 14 days prior to screening.
- Uncontrolled cardiovascular diseases within 6 months prior to screening.
- Known interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, and severe lung function abnormalities that may impede the investigators' diagnosis and management of drug-related pulmonary...
- Patients who have used traditional Chinese herbs or medicines with anti-tumor indications within 14 days prior to randomization.
- Patients who have received treatment with live vaccines within 28 days prior to randomization. Those who received inactivated viral vaccines for seasonal influenza or COVID-19 are eligible.
- Patients who have received any T-cell costimulatory agents or immune checkpoint blockade therapy, including but not limited to cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2...
- Radical radiotherapy within 4 weeks prior to randomization.
- Other prior/concomitant therapy: a) Treatment with strong CYP3A4 inducers within 1 week prior to randomization, including rifampin (and its analogues) or St. John's wort. b) Use of anticoagulants such as, warfarin or...
- Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or IMP administration, impair the ability of the subject to receive...
- Anaphylaxis to ipilimumab, nivolumab, or any other monoclonal antibody, or any component of the IMPs prior to screening.
- History of psychotropic substance abuse or illicit drug use as judged by the investigator prior to screening.
- Pregnant and lactating women, and those intending to become pregnant during the study or within 5 months after the last study treatment.
- Currently participating in another clinical study prior to screening, or less than 4 weeks or 5 half-lives of the IMPs in the previous study, whichever is longer, between the screening of the study and the end of...
- Patients who have other conditions not suitable for inclusion per investigator's judgments.
The study team makes the final eligibility decision.
Where it's taking place
- Glendale, California, United States
- Jacksonville, Florida, United States
- Margate, Florida, United States
- Orange City, Florida, United States
- Plantation, Florida, United States
- Tamarac, Florida, United States
- Brentwood, Tennessee, United States
- Houston, Texas, United States
- Olympia, Washington, United States
- Tacoma, Washington, United States
- Beijing, China
- Bengbu, China
- Changchun, China
- Changsha, China
- Chengdu, China
- Dongguan, China
- Fuzhou, China
- Ganzhou, China
- Guangzhou, China
- Haikou, China
+ 18 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glendale, California, United States; Jacksonville, Florida, United States; Margate, Florida, United States; Orange City, Florida, United States; Plantation, Florida, United States; Tamarac, Florida, United States and 32 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.