Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07176650
The ClinicalTrials.gov registry entry for NCT07176650 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 246 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 335-participant average among 15 other Hepatocellular Carcinoma (HCC) trials with a reported enrollment target (27% lower). The listed sponsor is Shanghai Henlius Biotech, which has 8 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.
-
ET140203 T Cells in Pediatric Subjects With Hepatoblastoma, HCN-NOS, or Hepatocellular Carcinoma
RECRUITING · Phase 1
-
Study of Zanzalintinib in Combination With Immuno-Oncology Agents in Participants With Solid Tumors
RECRUITING · Phase 1
-
A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced Solid Tumors (KEYNOTE-G08)
RECRUITING · Phase 1
-
A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206)
RECRUITING · Phase 1
-
A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies
RECRUITING · Phase 1
-
A Study of Cobolimab Plus Dostarlimab in Pediatric and Young Adult Participants With Cancer
ACTIVE NOT RECRUITING · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.