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

Study Identifier:
ZWI-ZW251-101
CT.gov Identifier:
NCT07164313
EudraCT Identifier:
2025-523088-39
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study 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). To evaluate safety and tolerability of ZW251 will be evaluated in patients with advanced solid tumors, including hepatocellular carcinoma. Part 1 (dose escalation) will determine the maximum tolerated dose (MTD) and recommended dose (RD). Part 2 (dose optimization) will evaluate the safety and potential antitumor activity of the RD

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Liver
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: ZW251 Drug: ZW251 Administered intravenously JRCT In Part 1 (dose escalation), ZW251 will be administered intravenously once every 21 days (Q3W). Approximately 6 dose levels are expected as follows: Level 1: 3.2 mg/kg, Level 2: 6.4 mg/kg, Level 3: 9.6 mg/kg, Level 4: 12.8 mg/kg, Level 5: 16 mg/kg, Level 6: 19.2 mg/kg. In Part 2 (dose optimization), ZW251 will be administered intravenously once every 21 days (3QW) at the two dose levels determined in Part 1.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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 diagnosisPathologically or cytologically confirmed diagnosis of squamous cell NSCLC with evidence of locally advanced (unresectable) and/or metastatic diseasePathologically or cytologically confirmed diagnosis of GCT with evidence of yolk sac and/or choriocarcinoma predominant component and locally advanced (unresectable) and/or metastatic diseaseMeasurable disease per RECIST v1.1Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1Liver function status of Child-Pugh Class A (for HCC only)Adequate organ function
    Exclusion criteria
    • Known additional malignancy that is progressing or that has required active treatment within the last yearHistory of hepatic encephalopathy within the past 6 months or requirement for medications to control encephalopathyParticipants with HCC experiencing main portal vein tumor invasion require sponsor approval for enrollmentKnown gastrointestinal bleeding within 3 monthsAcute or chronic uncontrolled renal disease, pancreatitis, or non-malignant liver disease

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Dublin
    Dublin, Ireland, D07 R2WY
    Investigator
    Austin Duffy
    Status
    Recruiting
    Condition(s) Treated at Site
    Liver
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Emiliano Calvo
    Status
    Recruiting
    Condition(s) Treated at Site
    Liver
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Manuel Pedregal Trujillo
    Status
    Recruiting
    Condition(s) Treated at Site
    Liver
    Location
    START Lisbon
    Lisbon, Portugal, 1649-035
    Investigator
    Andre Mansinho
    Status
    Recruiting
    Condition(s) Treated at Site
    Liver
    Location
    START Barcelona
    Barcelona, Spain, 08023
    Investigator
    Tatiana Hernandez Guerrero
    Status
    Recruiting
    Condition(s) Treated at Site
    Liver
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Muralidhar Beeram
    Status
    Recruiting
    Condition(s) Treated at Site
    Liver
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