A Phase 1 interventional study of ZW251 in Hepatocellular Carcinoma, Squamous Cell Non-Small Cell Lung Cancer and Germ Cell Tumor, sponsored by Zymeworks BC Inc.. Recruiting at 25 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Zymeworks BC Inc. (part of Zymeworks) · Phase 1, Interventional, and Treatment
The purpose of this study is to find out if ZW251, an antibody-drug conjugate targeting glypican-3 (GPC3), is safe and can treat participants with advanced cancers, including hepatocellular carcinoma (HCC), squamous cell non-small cell lung cancer (NSCLC), or germ cell tumors (GCT).
Part 1 (dose escalation) of the study will evaluate the safety and tolerability of ZW251 in HCC, squamous cell NSCLC, and GCT. Part 2 (dose optimization) of the study will further assess safety and potential anti-tumor activity of the ZW251 established recommended doses in HCC.
3,648 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,061 are open to participants now.
This study's planned enrollment of 140 is above the median of 54 across 2,618 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Zymeworks BC Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: ZW251
Administered intravenously
Incidence of dose-limiting toxicities (DLTs; Part 1)
Number of participants who experienced a DLT. DLTs include specifically defined adverse events (AEs) considered to be related to ZW251
Time frame: Up to 3 weeks
Incidence of AEs (Parts 1 and 2)
Number of participants who experienced AEs, adverse events of special interest, or serious adverse events
Time frame: Up to approximately 2 years
Incidence of clinical laboratory abnormalities (Parts 1 and 2)
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
Time frame: Up to approximately 2 years
Objective response rate (Part 2)
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
Time frame: Up to approximately 2 years
Objective response rate (Part 1)
Number of participants who achieved a best overall response of either confirmed CR or PR during treatment according to RECIST v1.1
Time frame: Up to approximately 2 years
Best overall response (Parts 1 and 2)
Time frame: Up to approximately 2 years
Disease control rate (Parts 1 and 2)
Number of participants who achieved a best response of CR, PR, or stable disease during treatment per RECIST v1.1
Time frame: Up to approximately 2 years
Duration of response (Parts 1 and 2)
The time from the first objective response (CR or PR) to the first documented progressive disease (PD) per RECIST v1.1 or death within 30 days of last dose of study treatment from any cause. Only participants who achieve a confirmed response will be included in the analysis
Time frame: Up to approximately 2 years
Progression-free survival (Part 2)
The time from the first dose of study treatment to the date of first documented PD per RECIST v1.1 or death from any cause
Time frame: Up to approximately 2 years
Area under the concentration-time curve (AUC0-504) of ZW251 (Parts 1 and 2)
Area under the concentration-time curve of ZW251 after first dose administration
Time frame: Up to approximately 2 years
Maximum concentration (Cmax) of ZW251 (Parts 1 and 2)
ZW251 maximum concentration after first dose administration
Time frame: Up to approximately 2 years
Area under the concentration-time curve of ZW251 at steady state (AUCtau,ss; Parts 1 and 2)
Area under the concentration-time curve of ZW251 at steady state after fourth dose administration
Time frame: Up to approximately 2 years
Maximum concentration of ZW251 at steady state (Сmax,ss; Parts 1 and 2)
ZW251 maximum concentration at steady state after fourth dose administration
Time frame: Up to approximately 2 years
Minimal concentration of ZW251 at steady state (Сmin,ss; Parts 1 and 2)
ZW251 minimal concentration at steady state after fourth dose administration
Time frame: Up to approximately 2 years
Incidence of anti-drug antibodies (ADAs; Parts 1 and 2)
Number of participants who develop ADAs
Time frame: Up to approximately 2 years
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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