A Study of ZW251 in Participants With Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorZymeworks BC Inc.
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
ZW251
DrugAdministered intravenously
Treatment groups
140 Participants
are divided into 1 treatment groupGroup A: ZW251Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 weeks2
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 years3
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 years4
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 yearsSecondary outcomes
1
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 years2
Best overall response (Parts 1 and 2)
Time frame
Up to approximately 2 years3
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 years4
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 yearsSponsors and contacts
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Source ClinicalTrials.gov