ZW49 for Cancer

Recruiting in Palo Alto (17 mi)

+16 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Zymeworks BC Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing ZW49, a new drug, to find the safest and most effective dose. It focuses on patients with advanced or metastatic HER2-positive cancers. The drug works by targeting and destroying cancer cells marked by the HER2 protein.

Research Team

Joseph Woolery, PharmD, BCOP

Principal Investigator

Zymeworks BC Inc.

Eligibility Criteria

This trial is for patients with advanced HER2-positive cancers, including breast cancer and gastroesophageal adenocarcinoma (GEA), who have tried standard treatments without success or cannot tolerate them. Participants must have a confirmed diagnosis, measurable disease for certain cohorts, an ECOG performance status of 0 or 1 indicating they are fully active or restricted in physically strenuous activity but ambulatory, and adequate organ function.

Inclusion Criteria

I have HER2-high breast cancer and was treated with trastuzumab, pertuzumab, and T-DM1.

My cancer can be measured or is known to exist.

I am fully active or can carry out light work.

See 11 more

Exclusion Criteria

I have been diagnosed with HIV.

I have a serious lung condition not caused by cancer spread.

I have stable, treated brain metastases and haven't needed steroids or seizure medicine for over a month.

See 4 more

Treatment Details

Interventions

ZW49 (Monoclonal Antibodies)

Trial OverviewThe study is testing ZW49 to find the highest dose patients can take without severe side effects (MTD) and to see how safe it is. It's open-label so everyone knows they're getting ZW49, and it starts by giving small doses that get bigger until they find the MTD or recommended dosage.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: ZW49Experimental Treatment1 Intervention