Zanidatamab + Evorpacept for Advanced HER2-Expressing Cancer

Recruiting at 14 trial locations

Overseen By Bruno Fang, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Jazz Pharmaceuticals

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

52 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a combination of two drugs, zanidatamab and evorpacept, to see if they are safe and effective for patients with advanced HER2-expressing cancers. The treatment works by targeting cancer cells and boosting the immune system. Evorpacept has been studied for its safety, tolerability, and antitumor activity in combination with other drugs like pembrolizumab and trastuzumab.

Research Team

Elaina Gartner, MD

Principal Investigator

Zymeworks Inc.

Phoebe Harvey, MD

Principal Investigator

Zymeworks BC Inc.

Eligibility Criteria

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.

Inclusion Criteria

My heart's left ventricle pumps well, with an efficiency of 50% or more.

My advanced cancer has worsened despite treatment.

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

Exclusion Criteria

I do not have another cancer that could affect this treatment's safety or results.

I have active hepatitis.

I do not have severe pancreatitis or advanced liver disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part 1: Safety and Tolerability

Evaluation of safety, tolerability, and establishment of recommended doses of zanidatamab in combination with evorpacept (ALX148)

Up to 7 months

Part 2: Anti-tumor Activity

Evaluation of anti-tumor activity of the combination of zanidatamab plus evorpacept (ALX148) at the recommended dose levels

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• ALX148
• Evorpacept
• Zanidatamab

Trial Overview 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.

Participant Groups

Group I: Zanidatamab plus evorpacept (ALX148) Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Jazz Pharmaceuticals

Lead Sponsor

Trials

252

Recruited

35,100+

Bruce C. Cozadd

Jazz Pharmaceuticals

Chief Executive Officer since 2009

BA in Economics from Yale University, MBA from Stanford University

Dr. Austin

Jazz Pharmaceuticals

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Zymeworks Inc.

Lead Sponsor

Trials

11

Recruited

2,400+

ALX Oncology Inc.

Industry Sponsor

Trials

9

Recruited

1,200+