RECRUITING

A Study of ZW251 in Participants With Advanced Solid Tumors

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Conditions

Hepatocellular CarcinomaGPC3-expressing cancerantibody drug conjugateADC

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2025-09
Study Completion:2028-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07164313

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Measurable disease per RECIST v1.1
  3. * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
  4. * Liver function status of Child-Pugh Class A
  5. * Adequate organ function
  1. * Known additional malignancy that is progressing or that has required active treatment within the last year
  2. * History of hepatic encephalopathy within the past 6 months or requirement for medications to control encephalopathy
  3. * Portal vein thrombosis within 3 months prior to Cycle 1 Day 1 that require coagulation therapy or is not stable
  4. * Known gastrointestinal bleeding within 3 months
  5. * Acute or chronic uncontrolled renal disease, pancreatitis, or non-malignant liver disease

Contacts and Locations

Study Contact

Zymeworks Clinical Trial Resource
CONTACT
(206) 237-1030
medinfo@zymeworks.com

Principal Investigator

Maggie Weinstein, MD, PhD, MPH
STUDY_DIRECTOR
Zymeworks BC Inc.

Study Locations (Sites)

START Midwest
Grand Rapids, Michigan, 49546
United States

Collaborators and Investigators

Sponsor: Zymeworks BC Inc.

  • Maggie Weinstein, MD, PhD, MPH, STUDY_DIRECTOR, Zymeworks BC Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09
Study Completion Date2028-05

Study Record Updates

Study Start Date2025-09
Study Completion Date2028-05

Terms related to this study

Keywords Provided by Researchers

  • GPC3-expressing cancer
  • hepatocellular carcinoma
  • antibody drug conjugate
  • ADC

Additional Relevant MeSH Terms

  • Hepatocellular Carcinoma