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Clinical Trials List

Protocol NumberZWI-ZW251-101
NCT Number(ClinicalTrials.gov Identfier)NCT07164313
Not yet recruiting

2025-09-24 - 2028-11-30

Phase I

Recruiting3

ICD-10C45.9

Mesothelioma, unspecified

ICD-10C79.9

Secondary malignant neoplasm of unspecified site

ICD-10C7A.00

Malignant carcinoid tumor of unspecified site

ICD-10C7A.094

Malignant carcinoid tumor of the foregut NOS

ICD-10C7A.095

Malignant carcinoid tumor of the midgut NOS

ICD-10C7A.096

Malignant carcinoid tumor of the hindgut NOS

ICD-10C7A.1

Malignant poorly differentiated neuroendocrine tumors

ICD-10C7A.8

Other malignant neuroendocrine tumors

ICD-10C7B.00

Secondary carcinoid tumors, unspecified site

ICD-10C80.1

Malignant (primary) neoplasm, unspecified

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9199.1

Malignant neoplasm of unspecified site (primary) (secondary)

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

  • Sponsor

    PPD DEVELOPMENT (HK) LIMITED TAIWAN BRANCH

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Yi-Hsiang Huang 醫學研究部

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ann-Lii Cheng Division of Hematology & Oncology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Cheng Chang

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Advanced Solid Tumors, Including Hepatocellular Carcinoma

Objectives

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).

Test Drug

ZW251

Active Ingredient

ZW251

Dosage Form

Infusion Solution

Dosage

ZW251

Endpoints

Primary Outcome Measures
Incidence of dose-limiting toxicities (DLTs; Part 1)
Incidence of AEs (Parts 1 and 2)
Incidence of clinical laboratory abnormalities (Parts 1 and 2)
Confirmed objective response rate (Part 2)

Inclution Criteria

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

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

The Estimated Number of Participants

  • Taiwan

    16 participants

  • Global

    100 participants