ZW49 for Cancer

Recruiting at 16 trial locations

Overseen By Zymeworks Clinical Trial Resource

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Zymeworks BC Inc.

Must be taking: Trastuzumab, Pertuzumab, T-DM1

Disqualifiers: Cardiac disease, Hepatitis, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

112 Participants Needed

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

3+3 dose-escalation study design to evaluate the safety and tolerability of ZW49 and determine the MTD or RD

Up to 4 weeks

Expansion Cohorts

Selected expansion cohorts to further evaluate the safety and tolerability of ZW49 at the MTD or RD and assess preliminary anti-tumor activity

Up to 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

Treatment Details

Interventions

• ZW49

Trial Overview The 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

Group I: ZW49 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Zymeworks BC Inc.

Lead Sponsor

Trials

6

Recruited

1,300+

Zymeworks Inc.

Lead Sponsor

Trials

11

Recruited

2,400+