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ZW191

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Zymeworks Inc.|Trials Updated: May 7, 2026

ZW191 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Aug 2024

ZW191 target and mechanism

Molecular targetFR⍺
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment145

FDA Designations

No designations recorded

ZW191 clinical trials

ZW191 · 1 trial · 1 indication

Phase 1 1
NCT06555744A Study of ZW191 in Participants With Solid TumorsAdvanced Solid Tumors
ACTIVE NOT_RECRUITING145 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study of ZW191 in Participants With Solid Tumors
Advanced Solid TumorsUnlock trial analytics

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 to 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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Competitive Landscape -Other Solid Tumors 10 trials (matched to "Advanced Solid Tumors")

Frequently asked questions about ZW191

What is ZW191 used for?

ZW191 is an investigational small molecule being studied for the treatment of advanced solid tumors. It is in Phase 1 clinical development and is not approved for any indication. The ongoing study enrolls adults with advanced solid tumors across the United States, Australia, Japan, Singapore, South Korea, and Spain.

What does ZW191 target?

ZW191 targets folate receptor alpha, also known as FR alpha, a protein expressed on certain tumor cells. By binding this target, ZW191 is designed to deliver its anti-tumor activity to FR alpha positive cancers. It is a small molecule therapeutic being developed for advanced solid tumors.

Who is developing ZW191?

ZW191 is being developed by Zymeworks Inc., a biopharmaceutical company listed on the Nasdaq under the ticker ZYME. Zymeworks is the sponsor of the Phase 1 clinical trial evaluating ZW191 in patients with advanced solid tumors.

What phase is ZW191 in?

ZW191 is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA or any regulatory authority. The Phase 1 trial is currently active and recruiting participants with advanced solid tumors.

What clinical trials is ZW191 in?

ZW191 is being evaluated in a single Phase 1 trial, NCT06555744, titled A Study of ZW191 in Participants With Solid Tumors. The trial has an estimated enrollment of 145 adults and is currently active but not recruiting. It is an open-label, uncontrolled study.