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A Study of ZW251 for Advanced Solid Tumors

This study is testing a drug called ZW251 to see if it is safe and effective for people with advanced cancers, including hepatocellular carcinoma (HCC, a type of liver cancer), squamous cell non-small cell lung cancer (NSCLC), or germ cell tumors. ZW251 is an antibody-drug conjugate, which means it's designed to deliver a drug directly to cancer cells. The study will look at side effects (adverse events) and how well ZW251 works. You may be able to join if you are 18 or older and have one of these advanced cancers. The study is currently recruiting about 100 participants.

Study design
This is an interventional study with an unclear phase, planning to enroll 100 participants. It will involve two parts: dose escalation and dose optimization.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for side effects and laboratory changes for up to approximately 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07164313

A Study of ZW251 in Participants With Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Zymeworks BC Inc.
~100 participants
Updated 2026-05-07 on ClinicalTrials.gov
What's tested:ZW251

At a glance

Recruiting sites
25 of 25 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of dose-limiting toxicities (DLTs; Part 1)
Measured over Up to 3 weeks
+3 more outcomes measured

Conditions

Hepatocellular Carcinoma
Squamous Cell Non-Small Cell Lung Cancer
Germ Cell Tumor

Explore related trials

Germ Cell TumorHepatocellular CarcinomaLung Non-Small Cell Squamous CarcinomaGlypican-3

Where it's being run

25 sites across 11 states
Spain8
Japan4
California2
Texas2
Portugal2
Taiwan2
Kentucky1
Michigan1

Study leadership

  • Maggie Weinstein, MD, PhD, MPH · STUDY_DIRECTOR · Zymeworks BC Inc.

Who to contact

Zymeworks Clinical Trial Resource
[email protected]
(206) 237-1030
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Pathologically or cytologically confirmed diagnosis of HCC with evidence of locally advanced (unresectable, and ineligible for transplant) and/or metastatic disease. Noninvasive methods may be used to confirm diagnosis
Pathologically or cytologically confirmed diagnosis of squamous cell NSCLC with evidence of locally advanced (unresectable) and/or metastatic disease
Pathologically or cytologically confirmed diagnosis of GCT with evidence of yolk sac and/or choriocarcinoma predominant component and locally advanced (unresectable) and/or metastatic disease
Measurable disease per RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
Liver function status of Child-Pugh Class A (for HCC only)
Adequate organ function

Exclusion

Known additional malignancy that is progressing or that has required active treatment within the last year
History of hepatic encephalopathy within the past 6 months or requirement for medications to control encephalopathy
Participants with HCC experiencing main portal vein tumor invasion require sponsor approval for enrollment
Known gastrointestinal bleeding within 3 months
Acute or chronic uncontrolled renal disease, pancreatitis, or non-malignant liver disease

What this trial measures

  • Incidence of dose-limiting toxicities (DLTs; Part 1)Up to 3 weeks

    Number of participants who experienced a DLT. DLTs include specifically defined adverse events (AEs) considered to be related to ZW251

  • Incidence of AEs (Parts 1 and 2)Up to approximately 2 years

    Number of participants who experienced AEs, adverse events of special interest, or serious adverse events

  • Incidence of clinical laboratory abnormalities (Parts 1 and 2)Up to approximately 2 years

    Number of participants who experienced a maximum severity of Grade 3 or higher post-baseline laboratory abnormality, including either hematology or chemistry. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0

  • Objective response rate (Part 2)Up to approximately 2 years

    Number of participants who achieved a best overall response of either confirmed complete response (CR) or partial response (PR) during treatment according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1