A Study of ZW191 in Participants With Solid Tumors

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.

Conditions

Advanced Solid Tumors

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Study Overview

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Study Details

Study overview

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.

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

A Study of ZW191 in Participants With Solid Tumors

Condition
Advanced Solid Tumors
Intervention / Treatment

-

Contacts and Locations

San Antonio

NEXT Oncology, San Antonio, Texas, United States, 78229

Fairfax

NEXT Virginia, Fairfax, Virginia, United States, 22031

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Pathologically or cytologically confirmed diagnosis of cancers with evidence of locally advanced (unresectable), recurrent and/or metastatic disease.
  • * Measurable disease per RECIST v1.1.
  • * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
  • * 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).
  • * Other adequate organ function.
  • * Known additional malignancy that is progressing or requires active treatment or may interfere with study endpoints.
  • * Has received prior Topoisomerase I inhibitor(TOPO1i) antibody drug conjugate treatment, regardless of washout period.
  • * Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease.
  • * Severe chronic or active infections (including known active SARS-CoV-2 infection) requiring systemic therapy, including antibacterial, antifungal, or antiviral therapy.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Zymeworks BC Inc.,

Joseph Woolery, PharmD, BCOP, STUDY_DIRECTOR, Zymeworks BC Inc.

Study Record Dates

2027-01