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Monoclonal Antibodies

Zanidatamab + Evorpacept for Advanced HER2-Expressing Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Jazz Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Progression after or during the most recent systemic regimen of treatment for advanced cancer with prior therapies including approved agents known to confer clinical benefit

Locally advanced (inoperable) and/or metastatic HER2-expressing cancer based on local or central laboratory test results

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is testing a new drug to see if it's safe and effective for treating patients with advanced HER2-expressing cancer.

Who is the study for?

This trial is for adults with advanced HER2-expressing cancers, including breast and gastroesophageal cancer. Participants must have had prior treatments, an ECOG performance status of 0 or 1 (which means they are fully active or restricted in physically strenuous activity but ambulatory), measurable disease, and adequate organ function. They cannot join if they've had recent heart issues, certain other cancers, uncontrolled diseases like pancreatitis or hepatitis, HIV unless well-controlled, brain metastases that are untreated or recently treated.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of zanidatamab combined with evorpacept in treating advanced HER2-expressing cancers. Zanidatamab targets proteins on cancer cells to stop growth while evorpacept helps the immune system attack the cancer.See study design

What are the potential side effects?

Potential side effects may include reactions related to the immune system's increased activity against cancer cells which can sometimes affect normal cells too. Specific side effects aren't listed but generally could involve fatigue, nausea, inflammation-related symptoms among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My advanced cancer has worsened despite treatment.

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My cancer is advanced, cannot be removed by surgery, and is HER2 positive.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am willing to have a new biopsy for HER2 testing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Confirmed objective response rate (ORR)(Part 2)

Incidence of AEs (Part 1)

Incidence of clinical laboratory abnormalities (Part 1)

+1 more

Secondary outcome measures

Clinical benefit rate (CBR)(Part 2)

Disease control rate (DCR)(Part 2)

Duration of response (DOR)(Part 2)

+8 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Zanidatamab plus evorpacept (ALX148)Experimental Treatment2 Interventions

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jazz PharmaceuticalsLead Sponsor

248 Previous Clinical Trials

34,192 Total Patients Enrolled

Zymeworks Inc.Lead Sponsor

10 Previous Clinical Trials

2,216 Total Patients Enrolled

ALX Oncology Inc.Industry Sponsor

8 Previous Clinical Trials

1,247 Total Patients Enrolled

Media Library

Zanidatamab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05027139 — Phase 1 & 2

Cancer Research Study Groups: Zanidatamab plus evorpacept (ALX148)

Cancer Clinical Trial 2023: Zanidatamab Highlights & Side Effects. Trial Name: NCT05027139 — Phase 1 & 2

Zanidatamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05027139 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

With how many people is this clinical trial being conducted?

"The sponsor, Zymeworks Inc., needs 93 patients that meet the clinical trial's requirements to start the study. The research will be conducted at different locations including University of Vermont Medical Center in Burlington, Vermont and Northwest Medical Specialties, PLLC in Tacoma, Washington."

Answered by AI

Can patients still join this clinical trial?

"The study, which is currently looking for willing participants, was first posted on September 15th 2021. The clinical trial information available online was last updated on September 2nd of this year."

Answered by AI

To your knowledge, how many times has Zanidatamab been tested in a clinical setting?

"Zanidatamab is the focus of 5 different clinical trials with 0 in Phase 3. While it's Anaheim, California that plays host to several of these studies, Zanidatamab is also being trialed in 138 other locations."

Answered by AI

Is this a new method being trialed?

"Zanidatamab is being trialed in 5 different studies across 9 countries and 45 cities. The first trial began in 2016 and was completed successfully in the Phase 1 drug approval stage. Zymeworks Inc. sponsored the study which enrolled 279 patients. Since then, 0 new trials have emerged."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Zanidatamab (ZW25) With Evorpacept (ALX148) in Patients With Advanced HER2-expressing Cancer

2021. "A Study of Zanidatamab (ZW25) With Evorpacept (ALX148) in Patients With Advanced HER2-expressing Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05027139.