145 Participants Needed

ZW191 for Advanced Cancers

Recruiting at 22 trial locations
ZC
Overseen ByZymeworks Clinical Trial Resource
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ZW191 to determine its safety and effectiveness for people with advanced cancers. The focus is on difficult-to-treat cancers such as ovarian, endometrial, and non-small cell lung cancers. The trial seeks participants with a confirmed diagnosis of these advanced cancers that cannot be surgically removed or have metastasized. Ideal candidates may have tried other treatments without success and have no other serious health issues that could affect the study. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on treatments for severe infections or have received certain cancer treatments before, it might affect your eligibility.

Is there any evidence suggesting that ZW191 is likely to be safe for humans?

Research has shown that ZW191 is safe for people with advanced solid tumors. In earlier studies, patients received doses up to 11.2 mg/kg without major problems. Most patients continued the treatment without significant issues, suggesting that ZW191 is generally well-tolerated in humans. While this is early evidence of safety, it encourages those considering participation in clinical trials for this treatment.12345

Why do researchers think this study treatment might be promising?

ZW191 is unique because it targets advanced cancers in a new way. Unlike traditional chemotherapy, which attacks all rapidly dividing cells, ZW191 is designed to specifically target cancer cells, potentially reducing side effects and improving effectiveness. Researchers are excited about ZW191's novel mechanism of action, which aims to disrupt cancer cell growth more precisely, offering hope for patients with limited treatment options.

What evidence suggests that ZW191 might be an effective treatment for advanced cancers?

Research has shown that ZW191, the investigational treatment in this trial, may help treat advanced cancers. Early results indicate that 44% of patients with these cancers responded to the treatment. Specifically, patients with gynecological cancers, such as ovarian and endometrial cancers, showed a 64% response rate when given higher doses. These findings suggest that ZW191 could be effective for these cancers, with positive responses even at lower doses. The treatment appears safe and well-tolerated, which is also promising.13678

Who Is on the Research Team?

AK

Akira Kojima, MD

Principal Investigator

Zymeworks BC Inc.

Are You a Good Fit for This Trial?

This trial is for people with advanced cancers like ovarian, endometrial, and non-small cell lung cancer. Participants must have a confirmed diagnosis of these cancers that are advanced or metastatic, measurable by certain criteria (RECIST v1.1), good heart function (LVEF ≥ 50%), and be in fairly good health overall (ECOG score of 0 or 1).

Inclusion Criteria

My organs are functioning well.
My heart pumps well, with an ejection fraction of 50% or higher.
My cancer is advanced, cannot be surgically removed, has come back, or has spread.
See 2 more

Exclusion Criteria

I do not have severe or active infections needing treatment.
I do not have another cancer that is getting worse or needs treatment.
I have been treated with a TOPO1i antibody drug before.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Evaluation of safety and tolerability of ZW191

3 weeks

Treatment Part 2

Further evaluation of safety and exploration of anti-tumor activity of ZW191

Up to approximately 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • ZW191
Trial Overview The study is testing ZW191 to see if it's safe and effective for treating participants with specific types of advanced cancers. It aims to understand the appropriate dosage and assess how well tumors respond to this treatment.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: ZW191Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Zymeworks BC Inc.

Lead Sponsor

Trials
6
Recruited
1,300+

Citations

Zymeworks Presents Initial Clinical Data from the Phase 1 ...Preliminary efficacy data, combined with a tolerable safety profile, reinforce the potential of ZW191 in patients with advanced solid tumors ...
Zymeworks Presents Initial Clinical Data from the Phase 1 ...Preliminary efficacy data, combined with a tolerable safety profile, reinforce the potential of ZW191 in patients with advanced solid tumors ...
AACR-NCI-EORTC: Preliminary Efficacy Data + Tolerable ...The initial results from the phase I study, which enrolled 41 patients, showed that ZW191 demonstrated an objective response rate (ORR) of 44% ...
A Study of ZW191 in Participants With Solid Tumors64% overall response rate in gynecological cancers at doses ≥6.4mg/kg. Responses observed at all doses evaluated at 3.2mg/kg....Dose optimization of ZW191 in ...
Zymeworks Provides Corporate Update and Reports Third ...As of the September 2025 data cut, objective response rates between 6.4 mg/kg to 9.6 mg/kg were: 53% (overall) and 64% (gynecological cancers).
A Study of ZW191 in Participants With Solid TumorsThe purpose of this study is to find out if ZW191 is safe and can treat participants with advanced cancers, including ovarian, endometrial, and non-small cell ...
ZWI-ZW191-101This is an ongoing, first-in-human, phase I study (ZWI-ZW191-101) of ZW191 in participants with advanced ovarian cancer (OC), endometrial cancer (EC), or non- ...
LB-A011ZW191 has been safely administered during dose escalation up to. 11.2 mg/kg, with most participants still on treatment.
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