A Study of ZW251 in Participants With Advanced Solid Tumors

About

Brief 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).

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 1

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

Inclusion Criteria:

Pathologically or cytologically confirmed diagnosis of HCC with evidence of locally advanced (unresectable, and ineligible for transplant) and/or metastatic disease. Noninvasive methods may be used to confirm diagnosis
Measurable disease per RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
Liver function status of Child-Pugh Class A
Adequate organ function

Exclusion Criteria:

Known additional malignancy that is progressing or that has required active treatment within the last year
History of hepatic encephalopathy within the past 6 months or requirement for medications to control encephalopathy
Portal vein thrombosis within 3 months prior to Cycle 1 Day 1 that require coagulation therapy or is not stable
Known gastrointestinal bleeding within 3 months
Acute or chronic uncontrolled renal disease, pancreatitis, or non-malignant liver disease

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