RECRUITING

A Study of ZW191 in Participants With Solid Tumors

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Conditions

Advanced Solid TumorsAdvanced or Metastatic CancersADCFolate alpha receptor

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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 ZW191 is safe and can treat participants with advanced cancers, including ovarian, endometrial, and non-small cell lung cancers.

Official Title

A Phase 1, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Ascending Doses of a Folate Receptor Alpha Antibody Drug Conjugate, ZW191, in Participants With Advanced Solid Tumors

Quick Facts

Study Start:2024-10-30
Study Completion:2027-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06555744

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 cancers with evidence of locally advanced (unresectable), recurrent and/or metastatic disease.
  2. * Measurable disease per RECIST v1.1.
  3. * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
  4. * Adequate cardiac function: Cardiac left ventricular function, as defined by left ventricular ejection fraction (LVEF) ≥ 50% as determined by either echocardiogram (ECHO) or multigated acquisition scan (MUGA).
  5. * Other adequate organ function.
  1. * Known additional malignancy that is progressing or requires active treatment or may interfere with study endpoints.
  2. * Has received prior Topoisomerase I inhibitor(TOPO1i) antibody drug conjugate treatment, regardless of washout period.
  3. * Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease.
  4. * Severe chronic or active infections (including known active SARS-CoV-2 infection) requiring systemic therapy, including antibacterial, antifungal, or antiviral therapy.

Contacts and Locations

Study Contact

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

Principal Investigator

Joseph Woolery, PharmD, BCOP
STUDY_DIRECTOR
Zymeworks BC Inc.

Study Locations (Sites)

NEXT Oncology
San Antonio, Texas, 78229
United States
NEXT Virginia
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Zymeworks BC Inc.

  • Joseph Woolery, PharmD, BCOP, 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 Date2024-10-30
Study Completion Date2027-01

Study Record Updates

Study Start Date2024-10-30
Study Completion Date2027-01

Terms related to this study

Keywords Provided by Researchers

  • Advanced or Metastatic Cancers
  • ADC
  • Folate alpha receptor

Additional Relevant MeSH Terms

  • Advanced Solid Tumors