A Study of ZW251 in Participants With Advanced Solid Tumors

a study on Hepatocellular Cancer Liver Cancer Solid Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
study ends around
Principal Investigator
by Katie Kelley, MD
Headshot of Katie Kelley
Katie Kelley

Description

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).

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

Details

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

Keywords

Hepatocellular Carcinoma, GPC3-expressing cancer, antibody drug conjugate, ADC

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UCSF Comprehensive Cancer Center accepting new patients
    San Francisco California 94158 United States
  • START San Antonio accepting new patients
    San Antonio Texas 78229 United States

Lead Scientist at UCSF

  • Katie Kelley, MD
    Dr. Robin Kate Kelley is a gastrointestinal oncologist who specializes in cancers arising from the liver, including hepatocellular carcinoma, bile duct cancer (cholangiocarcinoma), and gallbladder carcinoma.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Zymeworks BC Inc.
ID
NCT07164313
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 100 study participants
Last Updated
Contact us about this trial