NCT07164313

A Study of ZW251 in Participants With Advanced Solid Tumors

A First-In-Human, Phase 1, Open-Label, Multicenter Study of ZW251, a Novel Glypican-3 Targeting Antibody-Drug Conjugate, in Participants With Advanced Solid Tumors, Including Hepatocellular Carcinoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Zymeworks BC Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out if ZW251, an antibody-drug conjugate targeting glypican-3 (GPC3), is safe and can treat participants with advanced cancers, including hepatocellular carcinoma (HCC), squamous cell non-small cell lung cancer (NSCLC), or germ cell tumors (GCT).

Detailed description

Part 1 (dose escalation) of the study will evaluate the safety and tolerability of ZW251 in HCC, squamous cell NSCLC, and GCT. Part 2 (dose optimization) of the study will further assess safety and potential anti-tumor activity of the ZW251 established recommended doses in HCC.

Conditions

• Hepatocellular Carcinoma
• Squamous Cell Non-Small Cell Lung Cancer
• Germ Cell Tumor

Interventions

Type	Name	Description
DRUG	ZW251	Administered intravenously

Timeline

• Start date: 2025-10-21
• Primary completion: 2027-09-01
• Completion: 2028-05-01
• First posted: 2025-09-10
• Last updated: 2026-04-14

Locations

23 sites across 6 countries: United States, Ireland, Japan, Portugal, Spain, Taiwan

Regulatory

• FDA-regulated drug study