# 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

> **NCT07176650** · PHASE1 · RECRUITING · sponsor: **Shanghai Henlius Biotech** · enrollment: 246 (estimated)

## Conditions studied

- Hepatocellular Carcinoma (HCC)

## Interventions

- **DRUG:** HLX13
- **DRUG:** Yervoy
- **DRUG:** OPDIVO

## Key facts

- **NCT ID:** NCT07176650
- **Lead sponsor:** Shanghai Henlius Biotech
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2025-11-25
- **Primary completion:** 2026-12
- **Final completion:** 2026-12
- **Target enrollment:** 246 (ESTIMATED)
- **Last updated:** 2026-03-16


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT07176650

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07176650, "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". Retrieved via AI Analytics 2026-05-29 from https://api.ai-analytics.org/clinical/NCT07176650. Licensed CC0.

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