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ZW191

Phase 1

Advanced Solid Tumors | 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 Enrollment145
FDA Designations
FAST_TRACK
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06555744A Study of ZW191 in Participants With Solid TumorsPHASE1 ACTIVE NOT_RECRUITING 145Oct 30, 2024Jan 1, 2027May 7, 202627 United States, Australia +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 ZW191

Incidence of adverse events (AEs; Parts 1 and 2)
Up to approximately 2 years

Number of participants who experienced AEs, adverse events of special interest (AESIs), or serious adverse events (SAEs)

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 (CTCAE), version 5.0

Confirmed 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
Confirmed objective response rate (Part 1)
Up to approximately 2 years
Clinical benefit rate (Parts 1 and 2)
Up to approximately 2 years
Duration of response (DOR; Part 2)
Up to approximately 2 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ZW191EXPERIMENTAL -
Interventions
NameTypeDescription
ZW191DRUGAdministered intravenously
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites27

Inclusion Criteria: * Pathologically or cytologically confirmed diagnosis of cancers with evidence of locally advanced (unresectable), recurrent and/or metastatic disease. * Measurable disease per RECIST v1.1. * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. * Adequat...

Countries:United StatesAustraliaJapanSingaporeSouth KoreaSpain
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06555744Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT06555744studyFirstPostDate: changed