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ZW191

Phase 1

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

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

FAST_TRACK

Clinical trial landscape

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 9 trials (matched to "Advanced Solid Tumors")

Frequently asked questions about ZW191

What is ZW191 used for?

ZW191 is an investigational small molecule being developed for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied in a clinical trial enrolling participants with advanced solid tumors.

What does ZW191 target?

ZW191 targets folate receptor alpha (FR⍺), a protein that is often overexpressed in certain types of cancer cells. By targeting FR⍺, ZW191 aims to deliver its therapeutic effect specifically to tumor cells that express this receptor, potentially reducing damage to healthy cells.

Who is developing ZW191?

ZW191 is being developed by Zymeworks Inc., a biopharmaceutical company listed on the stock exchange under the ticker symbol ZYME. The company is conducting clinical trials to evaluate the safety and efficacy of ZW191 in patients with advanced solid tumors.

What phase is ZW191 in?

ZW191 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities such as the FDA. The ongoing Phase 1 trial is designed to assess the drug's safety, tolerability, and preliminary efficacy in patients with advanced solid tumors.

What clinical trials is ZW191 in?

ZW191 is being studied in a Phase 1 clinical trial with the identifier NCT06555744, titled 'A Study of ZW191 in Participants With Solid Tumors.' This trial is actively recruiting participants and has an estimated enrollment of 145 patients. The study is being conducted in the United States, Australia, Japan, Singapore, South Korea, and Spain.

Is ZW191 FDA approved?

ZW191 is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials. However, it has received Fast Track designation from the FDA, which is a process designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need.