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NCT07176650 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Hepatocellular Carcinoma (HCC), sponsored by Shanghai Henlius Biotech.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 246
- Enrollment target
- 20
- Study locations
NCT07176650: Recruiting Phase 1 study of Hepatocellular Carcinoma (HCC), sponsored by Shanghai Henlius Biotech.
NCT07176650 is a Phase 1 study of Hepatocellular Carcinoma (HCC) that is actively recruiting participants, run by Shanghai Henlius Biotech. The registered enrollment target is 246 participants, below the 335-participant average among 15 other Hepatocellular Carcinoma (HCC) trials with a reported enrollment target (27% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07176650, a Phase 1 study of Hepatocellular Carcinoma (HCC), is actively recruiting participants, sponsored by Shanghai Henlius Biotech.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 246 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Conditions Studied
Interventions
- DRUG HLX13
- DRUG Yervoy
- DRUG OPDIVO
Study Locations (20)
Other
- Cancer Hospital Chinese Academy of Medical Sciences - Beijing
- Peking Union Medical College Hospital - Beijing
- Peking university international hospital - Beijing
- The First Affiliated Hospital of Bengbu Medical University - Bengbu
- JiLin Cancer Hospital - Changchun
- The First Hospital of Jilin University - Changchun
- People's Hospital of Hunan Province - Changsha
- Chengdu Fifth People's Hospital - Chengdu
- Sichuan Cancer Hospital - Chengdu
Florida
- Cancer Specialists of North Florida - Jacksonville
- D&H National Research Centers, LLC - Margate
- Mid Florida Hematology and oncology Center - Orange City
- Florida Clinical Trials Group - Plantation
- Florida Clinical Trials Group - Tamarac
California
- Oncology Physicians Network (OPN) - Los Alamitos /OPN Healthcare - Glendale
- Los Angeles Cancer Network - Glendale
Washington
- American Oncology Network Vista Oncology Division/Physician Partner Associate - Olympia
- Northwest Medical Specialties PLLC (NWMS) - Tacoma
Tennessee
- HCA Research Institute, LLC - Brentwood
Texas
- Oncology Consultants - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 246 participants |
| Start Date | 2025-11-25 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What NCT07176650 shows while recruiting
NCT07176650 is an interventional study that assigns participants to a tested intervention. The registered 246 participants enrollment target is mid-sized for trials with a published cap, below the 335-participant average among 15 other Hepatocellular Carcinoma (HCC) trials with a reported enrollment target (27% lower).
The record links to 1 condition, with Hepatocellular Carcinoma (HCC) appearing as the primary indexed condition, and to 3 interventions - of which HLX13 is the first listed.
NCT07176650 names 20 study sites across 6 states, led by Other, Florida, California.
Frequently Asked Questions
What is clinical trial NCT07176650 about?
NCT07176650 is a clinical study titled "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". 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.
What is the current status of trial NCT07176650?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 246 participants. The study started on 2025-11-25. Estimated completion is 2026-12.
What conditions does trial NCT07176650 study?
This clinical trial studies the following conditions: Hepatocellular Carcinoma (HCC).
What interventions are being tested in trial NCT07176650?
The interventions under investigation include: HLX13 (DRUG), Yervoy (DRUG), OPDIVO (DRUG).
Who is sponsoring clinical trial NCT07176650?
This trial is sponsored by Shanghai Henlius Biotech, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07176650 being conducted?
This trial has 20 study locations across California, Florida, Tennessee, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatocellular Carcinoma (HCC)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07176650's enrollment target sits among peer trials
246 7th of 15 higher than 9 of 15 other Hepatocellular Carcinoma (HCC) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatocellular Carcinoma (HCC) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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