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Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers

NCT02892123 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 279

Last updated 2024-11-27

No results posted yet for this study

Summary

This is a first-in-human, 3-part study to investigate the safety, tolerability, and effectiveness of ZW25 (zanidatamab) by itself and combined with selected chemotherapy agents in patients with locally advanced (unresectable) and/or metastatic human epidermal growth factor receptor 2 (HER2)-expressing cancers. This study will also the evaluate the way the body absorbs, distributes, and eliminates ZW25 (pharmacokinetics or PK).

Conditions

  • HER2-expressing Cancers

Interventions

DRUG

ZW25 (Zanidatamab)

ZW25 administered IV once weekly, once every 2 weeks, or once every 3 weeks. Part 1: in multiple increasing doses; Part 2: ZW25 given at the MTD, OBD, or an RD identified in Part 1; Part 3: ZW25 given at the MTD, OBD, or an RD combined with one of the following selected drug combination:

DRUG

Paclitaxel

Combination therapy with ZW25 - Part 3 Treatment Groups 1 and 4

DRUG

Capecitabine

Combination therapy with ZW25 - Part 3 Treatment Groups 2 and 5

DRUG

Vinorelbine

Combination therapy with ZW25 - Part 3 Treatment Groups 3 and 6

DRUG

Tucatinib

Combination therapy with ZW25 and Capecitabine - Part 3 Treatment Group 7

DRUG

Tucatinib

Combination therapy with ZW25 - Part 3 Treatment Group 8 (may be opened if recommended by the Safety Monitoring Committee and/or the sponsor)

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2024-10-31
Completion
2024-10-31

Countries

  • United States
  • Canada
  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT02892123 on ClinicalTrials.gov