A Study of ZW251 in Participants With Advanced Solid Tumors

a study on Hepatocellular Cancer Liver Cancer Lung Cancer Non-Small Cell Lung Cancer Germ Cell Tumor Solid Tumor Lung Tumor Squamous Cell Carcinoma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSF
Dates
study started
study ends around
Principal Investigator
by Robin Kate Kelley (ucsf)

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), squamous cell non-small cell lung cancer (NSCLC), or germ cell tumors (GCT).

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, squamous cell NSCLC, and GCT. 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, Squamous Cell Non-Small Cell Lung Cancer, Germ Cell Tumor, GPC3-expressing cancer, antibody drug conjugate, ADC, Lung Cancer, Non-Small Cell Lung Cancer, Squamous Cell Cancer, Germ Cell and Embryonal Neoplasms, Lung Neoplasms, Non-Small-Cell Lung Carcinoma, Squamous Cell Neoplasms

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
  • Pathologically or cytologically confirmed diagnosis of squamous cell NSCLC with evidence of locally advanced (unresectable) and/or metastatic disease
  • Pathologically or cytologically confirmed diagnosis of GCT with evidence of yolk sac and/or choriocarcinoma predominant component and locally advanced (unresectable) and/or metastatic disease
  • 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 (for HCC only)
  • 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
  • Participants with HCC experiencing main portal vein tumor invasion require sponsor approval for enrollment
  • 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
  • University of California Los Angeles - Cancer Care - Santa Monica (UCLA) accepting new patients
    Santa Monica California 90404 United States

Lead Scientist at University of California Health

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