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ZW251

Phase 1

Hepatocellular Carcinoma | Small molecule | Oncology |Zymeworks Inc.|Last Updated: May 7, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07164313A Study of ZW251 in Participants With Advanced Solid TumorsPHASE1 RECRUITING 100Oct 21, 2025May 1, 2028May 7, 202625 United States, Ireland +4
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Study Endpoints
Primary Endpoints
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

Secondary Endpoints
Objective response rate (Part 1)
Up to approximately 2 years
Best overall response (Parts 1 and 2)
Up to approximately 2 years
Disease control rate (Parts 1 and 2)
Up to approximately 2 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ZW251EXPERIMENTAL -
Interventions
NameTypeDescription
ZW251DRUGAdministered intravenously
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites25

Inclusion Criteria: * 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 s...

Countries:United StatesIrelandJapanPortugalSpainTaiwan
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07164313primaryCompletionDate: changed
LOWMay 24, 2026NCT07164313studyFirstPostDate: changed