ZW25 (Zanidatamab) for HER2-expressing Gastrointestinal Cancers

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
HER2-expressing Gastrointestinal CancersZW25 (Zanidatamab) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer drug, zanidatamab, to see if it is safe and effective for treating certain types of gastrointestinal cancers. Eligible patients have cancer that has spread and cannot be removed by surgery.

Eligible Conditions
  • HER2-expressing Gastrointestinal Cancers

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 12 Secondary · Reporting Duration: Up to 2 years

Up to 10 months
Disease control rate (Parts 1 and 2)
Objective response rate (ORR) (Part 1)
Objective response rate (ORR) (Part 2)
Up to 11 months
End of infusion concentration of ZW25 (Parts 1 and 2)
Incidence of adverse events (Part 1)
Incidence of adverse events (Part 2)
Incidence of anti-drug antibodies (ADAs) (Parts 1 and 2)
Incidence of lab abnormalities (Part 1)
Incidence of lab abnormalities (Part 2)
Maximum serum concentration of ZW25 (Parts 1 and 2)
Trough concentration of ZW25 (Parts 1 and 2)
Up to 2 years
Clinical benefit rate (Parts 1 and 2)
Duration of response (Parts 1 and 2)
Overall survival (Parts 1 and 2)
Progression-free survival (Parts 1 and 2)
Up to 6 weeks
Incidence of dose-limiting toxicities (DLTs) (Part 1)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

5 Treatment Groups

ZW25 + XELOX
1 of 5
ZW25 + mFOLFOX6 with bevacizumab
1 of 5
ZW25 + FP
1 of 5
ZW25 + mFOLFOX6
1 of 5
ZW25 + CisGem
1 of 5

Experimental Treatment

362 Total Participants · 5 Treatment Groups

Primary Treatment: ZW25 (Zanidatamab) · No Placebo Group · Phase 2

ZW25 + XELOXExperimental Group · 3 Interventions: ZW25 (Zanidatamab), Capecitabine, Oxaliplatin · Intervention Types: Drug, Drug, Drug
ZW25 + mFOLFOX6 with bevacizumabExperimental Group · 5 Interventions: ZW25 (Zanidatamab), Oxaliplatin, Bevacizumab, Fluorouracil, Leucovorin · Intervention Types: Drug, Drug, Drug, Drug, Drug
ZW25 + FPExperimental Group · 3 Interventions: ZW25 (Zanidatamab), Cisplatin, Fluorouracil · Intervention Types: Drug, Drug, Drug
ZW25 + mFOLFOX6Experimental Group · 4 Interventions: ZW25 (Zanidatamab), Oxaliplatin, Fluorouracil, Leucovorin · Intervention Types: Drug, Drug, Drug, Drug
ZW25 + CisGemExperimental Group · 2 Interventions: Gemcitabine, Cisplatin · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
FDA approved
Capecitabine
FDA approved
Oxaliplatin
FDA approved
Bevacizumab
FDA approved
Cisplatin
FDA approved
Fluorouracil
FDA approved
Leucovorin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

Zymeworks Inc.Lead Sponsor
10 Previous Clinical Trials
2,288 Total Patients Enrolled
Jonathan Grim, MD, PhDStudy DirectorZymeworks Inc.
1 Previous Clinical Trials
714 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have HER2-expressing, locally advanced, recurrent or metastatic colorectal cancer
You have CRC: Same as Part 1\n\nCriterion: Plasma concentration of creatinine < 0.
You have measurable disease.\n
You have a performance status of 0 or 1.
You have adequate organ function.