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A Dose Finding Study of ZW49 in Patients With HER2-Positive Cancers

NCT03821233 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2025-01-29

No results posted yet for this study

Summary

This is a first-in-human, Phase 1, multicenter, open-label, dose-escalation study to establish the maximum-tolerated dose (MTD) or recommended dosage (RD) of ZW49, the investigational agent under study, and to assess the safety and tolerability of ZW49. Eligible patients include those with locally advanced (unresectable) or metastatic HER2-expressing cancers.

Conditions

  • HER2-expressing Cancers

Interventions

DRUG

ZW49

* Dose Escalation: ZW49 administered intravenously at dose levels determined by the SMC * Expansion: MTD or RD identified in the dose-escalation part of the study

Sponsors & Collaborators

  • Zymeworks BC Inc.

    lead INDUSTRY

Principal Investigators

  • Joseph Woolery, PharmD, BCOP · Zymeworks BC Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-15
Primary Completion
2024-09-27
Completion
2024-10-08
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03821233 on ClinicalTrials.gov